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| CMP-0001-26 | 01/01/2026 | RA | Permanent | Major | Overprinting of QR matrix code, GTIN number and Serial Number on unit cartons of Pharmaceutical products exporting in Uzbekistan and implementation of aggregation process. | Currently, products exporting to Uzbekistan only contain batch number, manufacturinng date and expiry date on finished product. | 1) It is proposed to carry out overprinting of QR matrix codes, GTIN numbers, and serial numbers on the unit cartons of pharmaceutical products intended for export to Uzbekistan as per following information.
The QR matrix code will contain specific product and serialization information. This data will provided by our partner in Uzbekistan in the form of an excel sheet. The data in the sheet will be converted in the form of data matrix codes. The information will be unique to each individual unit carton and will be shared by the partner separately for each upcoming order destined for the Uzbekistan market.
GTIN number: (Already provided by PharmEvo to partner and will be included in the excel sheet shared by partner)
Serial Number: (Will be provided by partner)
Individual Sequence number: (Will be provided by partner)
Verification code: (Will be provided by partner)
While following information will be printed in human readable form in the following format:
GTIN:
BATCH NO:
MFG:
EXP:
SN:
2) Aggregation process will be implemented for all pharmaceutical products exporting in Uzbekistan. | N/A | Approved | 31/05/2026 | In Progress | Pharma | 1) Serial number, individual sequence number and verification codes required for printing on each unit carton of Uzbekistan order products. (RA)
2) Excel sheet data will be integrated with the PharmaTrax software for code management. (RA)
3) Tertiary packaging (Master carton) label will be generated through pharmatrax software containing all information on unit carton. (RA & Production)
4) Software verification will be performed. QA (Val)
5) Instruction will be incorporate in EPO. (SCM)
6) For every upcoming order for Uzbekistan SCM will inform immediately to RA for the issuance of verification code/ Information in password protected excel sheet. (SCM & RA)
07) SOP to be developed for QR code management for the Uzbekistan. (RA)
08) SOP for the pharmatrax software will be revised to include operation and reconciliation of codes. (Production)
| 01) Done
02) Done
03) Done
04) Done
05) Done
06) Done
| 01) Jan-26
02) Jan-26
03) Jan-26
04) Feb-26
05) Feb-26
06) Jan-26
07) May-26 (Extension till Dec-26)
08) May-26 (Extension till Dec-26)
| Hamza Ahmed | 01/01/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0002-26 | 01/01/2026 | QC | Temporary | Minor | Due to malfunction observed in the IR system within the QC department, IR based identification testing is temporarily unavailable. | Currently, there is a malfunctioning observed in the IR equipment within the QC department, which is preventing the release of materials. | All raw materials will be released using alternative identification methods until the IR equipment is operational. | N/A | Approved | 28/02/2026 | Closed | Pharma | 01) Vendor inspection report required. (QC)
02) Alternate ID test will be perform for raw materials. (QC)
03) Performance Qualification will be perform after the IR system is operational. (QC)
| 01) Done
02) Done
03) Done
| 01) Feb-26
02) Feb-26
03) Feb-26
| Hamza Ahmed | 01/01/2026 | Muhammad Haris | 18/03/2026 |
|
| CMP-0003-26 | 07/01/2026 | QC | Permanent | Moderate | Sampling of Nutraceutical APIs will be carried out as per vN +1 rule. | Currently, sampling of nutraceutical APIs is performed on 100% of containers for identification. | It is proposed that sampling of all nutraceutical APIs will be carried out in accordance with the vN +1 rule. | N/A | Approved | 31/03/2026 | Closed | Pharma | 1) SOP will be developed. (QC)
2) Training will be provided to concern person. (QC)
| 01) Done
02) Done
| 01) March-26
02) March-26
| Hamza Ahmed | 07/01/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0004-26 | 07/01/2026 | SCM | Permanent | Major | Alternate source induction for Empty Shell Hard Gelatin Capsule Size 0,1 & 2. | We are currently purchasing Empty Hard Gelatin Capsules Size 0,1 & 2 from M/s Health Capsules Pakistan Add: P-25, Phase 1-A, Sahiawala Industrial Estate, FIEDMC, Faisalabad | It is proposed to induct one more source M/s. PharmNova Pvt Ltd. located at Plot # 154 & 93, Deh Kanto Tappo, Landhi Bin Qasim, Karachi | N/A | Approved | 31/12/2026 | In Progress | Pharma | 1) Source approval document will be submitted to QA. (SCM)
2) Procurement of material from new source. (SCM)
3) Vendor list will be updated. (QA)
4) Source name will be added in SAP. (QC)
5) Process validation will be performed. QA(Val)
6) Stability will be performed on validation batches. (QC)
| 01) Done
02) Done
03) Done
04) Done
| 01) Jan-26
02) Jan-26
03) Feb-26
04) Done
05) Dec-26
06) Dec-26
| Hamza Ahmed | 08/01/2026 | Muhammad Haris | 11/03/2026 |
|
| CMP-0005-26 | 08/01/2026 | BD | Permanent | Minor | Revision of Zi-AD Syrup Label (5mg/5ml). | The currently approved label dimensions for Zi-AD Syrup are not compatible with the 60ml PET bottle dimensions.
Existing label dimensions: 50mmx85mm. | Revision of label dimension inline with 60ml PET bottle dimensions.
Proposed Label Dimensions: 50mmx85mm | N/A | Approved | 31/03/2026 | Closed | Pharma | 01) Artwork will be developed. (BD)
02) Item code will be open. (BD)
03) Existing inventory will be write off. (SCM)
04) Old item code will be block for procurement. (SCM)
05) BOM will be revise in SAP. (QA)
06) PO will be revise. (QA)
| 01) Done
02) Done
03) Done
04) Done
05) Done
06) Done
| 01) Done
02) Done
03) Done
04) Done
05) March-26
06) March-26
| Hamza Ahmed | 08/01/2026 | Muhammad Haris | 13/05/2026 |
|
| CMP-0006-26 | 13/01/2026 | BD | Permanent | Moderate | Revision of GTM artworks as per EXGP-S. | Currently, all products commercialized in Guatemala are assigned country-specific finished goods (FG) and packaging (PKG) codes. The artworks are also country-specific. | Existing artworks will be revised to allign with EXGP-S requirement. The current orders will be processed using the existing Guatemala-specific FG codes with new EXGP-S Artwork. New orders will be subsequently placed using FG codes in accordance with EXGP-S | N/A | Approved | 31/08/2026 | In Progress | Pharma | 01) Notification required from ministry. (RA)
02) Development and approval of artwork. (BD)
03) Item code will be open. (BD)
04) FG code will be open. (SCM)
05) Existing inventory will be write off. (SCM)
06) Old item code will be block for procurement. (SCM)
07) BOM will create in SAP. (QA)
08) BPR will be prepared. (QA)
09) Procurement of packaging material. (SCM)
10) Specification will be updated in SAP. (QC)
|
| 01) June-26
02) June-26
03) June-26
04) June-26
05) June-26
06) June-26
07) June-26
08) June-26
09) June-26
10) Aug-26
| Hamza Ahmed | 13/01/2026 | Muhammad Haris | 18/03/2026 |
|
| CMP-0007-26 | 13/01/2026 | PD | Permanent | Major | Change in Formulation of Finerdia 10mg tablet & Finerdia 20mg tablet. | 1. The product is currently manufactured as per the formulation in Annexure-1
2. Currently Opadry White 03F580033 is being utilized in the formulation. | 1. The proposed formulation is qualitatively similar to the existing but differs quantitatively as mentioned in annexure-1.
2. Replacing Opadry White 03F580033 with sheffcoat PVA White to improve the physical appearance of tablet. | RA-0003-26-P | Approved | 30/04/2026 | In Progress | Pharma | 01) PD trial is required. (PD)
02) SFG BOM will be revise in SAP. (QA)
03) BDR & BMR will be revise. (QA)
04) Routing will be created in SAP. (Prod)
05) Process Validation will be performed. QA(Val)
06) Stability will be performed on validation batches. (QC)
| 01) Done
02) Done
03) Done
04) Done
| 01) Done
02) Jan-26
03) Jan-26
04) Jan-26
05) April-26 (Extension till June-26)
06) April-26 (Extension till June-26)
| Hamza Ahmed | 13/01/2026 | Muhammad Haris | 09/05/2026 |
|
| CMP-0008-26 | 13/01/2026 | Engineering | Permanent | Moderate | Installation of non-returnable valves at all points of compressed air in the production area. | Currently, ball valve are install at compressed air point of use total 31 valves are served in the production areas. | It is proposed to installed non return valves at compressed air point of use in order to compliant with GMP requirement. | N/A | Approved | 31/03/2026 | Closed | Pharma | 01) Installation of non-return valves at all points of compressed air. (Engineering)
02) Inspection of non-return valves will be added in current preventive maintenance program. (Engineering)
03) Chemical testing of product contact point will be perform. QC & QA (Val)
04) Micro testing of product contact point will be perform. QC (Micro)
05) Compressed air layout need to be developed with IDs. (Engineering)
| 01) Done
02) Done
03) Done
04) Done
05) Done
| 01) Feb-26
02) Feb-26
03) March-26
04) Feb-26
05) Feb-26
| Hamza Ahmed | 13/01/2026 | Muhammad Haris | 09/05/2026 |
|
| CMP-0009-26 | 13/01/2026 | QA | Permanent | Moderate | Change in Batch Numbering System for Pharma and Nutra products. | Currently, batch numbering system for pharma products consist of five alphanumeric characters.(i.e. 6A001) and for nutra batch numbering system consist of six alphanumeric characters.(i.e. N6A001).
For Pharma:
B.No =6A001
First letter “6” represents the year
2nd letter “A” represents the month of dispensing
Last three letters “001”Serial number of batches in a month.
For Nutra:
B.No =N6A001
First letter “N” represents the nutra
2nd letter “6” represents the year
3rd letter “A”represents the month of dispensing
Last three letters “001” serial number of batches in a month. | It is proposed to change the batch numbering system for pharma products to six Alphanumeric characters.(i.e. 26A001) and for nutra batch numbering system to seven alphanumeric
characters.(i.e. N26A001).
For Pharma:
B.No =26A001
First two letter “26” represents the year
3rd letter “A” represents the month of dispensing
Last three letters “001”Serial number of batches in a month.
For Nutra:
B.No =N26A001
First letter “N” represents the nutra
2nd and 3rd letter “26” represents the year
4th letter represents the month of dispensing
Last three letters 001=Serial number of batches in a month. | RA-0004-26-P | Under Approval | | | Pharma |
|
|
| Hamza Ahmed | 13/01/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0010-26 | 15/01/2026 | BD | Permanent | Moderate | Revision in PS Unit Carton Dimensions for Emglin 25mg Tablets- Central America. | Current;y, the dimensions of the U/C are not adequate to accommodate the Direction Insert (DI). Existing U/C Dimension: 85mmx60mmx15mm. | The U/C dimensions of Emglin 25mg Tablet (PS) will be revised to align with the size requirements of the Direction Insert (DI).
Proposed U/C Dimension: 95mmx70mmx20mm. | N/A | Approved | 30/04/2026 | Closed | Pharma | 01) Development and approval of artwork. (BD)
02) Item code will be open. (BD)
03) Existing inventory will be write off. (SCM)
04) Old item code will be block for procurement. (SCM)
05) BOM will be create in SAP. (QA)
06) BPR will be prepared. (QA)
07) Procurement of packaging material. (SCM)
08) Specification will be updated in SAP. (QC)
| 01) Done
02) Done
03) Done
04) Done
05) Done
06) Done
07) Done
08) Done
| 01) Done
02) Done
03) Feb-26
04) Feb-26
05) Mar-26
06) Mar-26
07) April-26
08) April-26
| Hamza Ahmed | 15/01/2026 | Muhammad Haris | 30/06/2026 |
|
| CMP-0011-26 | 16/01/2026 | Production | Permanent | Major | Transfer of export group A (EXGP-A) products to Hoonga blister machine. | The products mentioned on the attached list are currently being blistered on BM-350 blister machine (List attached). | The products mentioned on the attached list are agreed to move to the Hoonga Blister Machine. (list attached) | RA-0006-26-P | Approved | 31/12/2027 | In Progress | Pharma | 01) Annual notification will be applied in Nigeria and Ghana. (RA)
02) Variation will be applied in Kenya and French West African countries before implementation. (RA)
03) Approval is required for additional pack size in export countries before implementation. (RA)
04) Artwork will be develop as per Hoonga Blister Machine. (BD)
05) Item code will be open. (BD)
06) Procurement of packaging material. (SCM)
07) Existing inventory will be consume. (SCM)
08) BOM will be revise in SAP. (QA)
09) BPR will be revise. (QA)
10) Process validation will be perform by matrixing approach. QA (Val)
11) Specification will be updated in SAP. (QC)
|
| 01) June-26
02) Sep-26
03) Sep-26
04) Jan-27
05) Jan-27
06) June-27
07) June-27
08) Aug-27
09) Aug-27
10) Dec-27
11) Dec-27
| Hamza Ahmed | 16/01/2026 | Muhammad Haris | 17/06/2026 |
|
| CMP-0012-26 | 16/01/2026 | QC | Temporary | Minor | Temporary use of QC ceph lab UV spectrophotometer for QC general pharma testing. | The UV spectrophotometer (UV-01) installed in the QC General Pharma area is out of order. Therefore, batches requiring UV analysis are currently pending at QC testing. | It is proposed that samples to be prepared in the QC General Pharma area and then sent to the QC Ceph Lab for performing the UV analysis. The samples will be discarded in the Ceph lab after analysis to avoid cross-contamination. Documents (UV report) will be shared via email. All the raw data and other documents will be maintained in General Pharma QC Lab. | N/A | Approved | 31/03/2026 | Closed | Pharma | 01) Vendor inspection report required. (QC)
02) Evidence of all activities perform in Ceph area will be perform. (QC)
03) Performance qualification will be perform. (QC)
| 01) Done
02) Done
03) Done
| 01) March-26
02) March-26
03) March-26
| Hamza Ahmed | 16/01/2026 | Muhammad Haris | 09/05/2026 |
|
| CMP-0013-26 | 16/01/2026 | SCM | Permanent | Moderate | Institution order of MCC KPK. | Order of MCC KPK is received from institution market. | We have reviewed order of following products from MCC KPK.
01) BOM code: BOM code required. Product: Cap Zoltar 40mg. Material Status: AF need to be develope. Order Qty: 145,000. Institute: MCC KPK Supplies 2025-26.
02) BOM code: BOM code required. Product: Tab Tansin 50mg. Material Status: AF need to be develope. Order Qty: 90,000. Institute: MCC KPK Supplies 2025-26.
03) BOM code: BOM code required. Product: Tab Zilfom 400mg. Material Status: AF need to be develope. Order Qty: 52,000. Institute: MCC KPK Supplies 2025-26.
04) BOM code: BOM code required. Product: Tab Evopride 2mg. Material Status: AF need to be develope. Order Qty: 10,500. Institute: MCC KPK Supplies 2025-26.
05) BOM code: BOM code required. Product: Tab Aireez 10mg. Material Status: AF need to be develope. Order Qty: 10,000. Institute: MCC KPK Supplies 2025-26.
For Aluminium Foil:
Base color in green with stamp of "GOVERNMENT OF KHYBER PAKHTUNKHWA MCC SUPPLY- NOT FOR SALE".
Commercial Packs with stamp of "GOVERNMENT OF KHYBER PAKHTUNKHWA MCC SUPPLY- NOT FOR SALE". | N/A | Approved | 30/04/2026 | Closed | Pharma | 01) Development and approval of artwork. (BD)
02) Item code will be open. (BD)
03) FG code will be open. (SCM)
04) BOM will be created in SAP. (QA)
05) BPR will be prepared. (QA)
06) Specification will be updated in SAP. (QC)
| 01) Done
02) Done
03) Done
04) Done
05) Done
06) Done
| 01) Done
02) Done
03) Done
04) Feb-26
05) March-26
06) April-26
| Hamza Ahmed | 16/01/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0014-26 | 16/01/2026 | QA | Permanent | Major | Change of PW loop temperature from 80ºC to ambient temperature (25-30ºC). | Currently Purified water is continuously circulated in loop at 80ºC (±5ºC).
| It is proposed to reduce temperature of purified water loop to ambient temperature (25-30ºC). However, due to this purpose change sanitization frequency need to be defined and qualification of purified water system loop will be performed. | RA-0001-26-P | Approved | 30/06/2026 | In Progress | Pharma | 1) Qualification will be performed (validation)
2) Dead leg study will be performed (Engineering)
3) Cleaning procedure with ambient water temperature will be checked for cleaning effectiveness (PD)
4) SOP for sanitization of purified water tank and loop (ENG/2/101) will be revised (Engineering)
5) SOP for "operation of purified water loop heat exchanger" (ENO/2/134) will be obsoleted (engineering)
6) SOP for cleaning of utensils (scoops, spoons, measuring cylinder and sampling thives used in warehouse (WHG/2/033) will be revised. (warehouse)
7) All relevant SOPs of production for cleaning with purified water will be revised to change temperature from 80C to ambient (production)
|
| 01) July-26
02) July-26
03) July-26
04) July-26
05) July-26
06) July-26
07) Sep-26
| Hamza Ahmed | 16/01/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0015-26 | 21/01/2026 | SCM | Temporary | Moderate | Over printing of suffix with batch number for the identification of different shelf life in same batch. | The Products(s) and Batch(es) has already been packed & invociesd as per procedure for export in FWA region. | We need to over print batch. no with mentioning the suffix for identification of different shelf life in sam batch (i.e 24 months(s) and 36 months(s)).
Details of products with complete details is attached. | N/A | Approved | 31/01/2026 | Closed | Pharma | 01) for products distributed in different countries under the same batch number but with different shelf life then suffix "A" will be printed with the batch number for those products whose shelf life is 36 months.
02) COA will be prepared. (QC)
03) Batch Release Certificate will be prepared. (QA)
| 01) Done
02) Done
03) Done
| 01) Jan-26
02) Jan-26
03) Jan-26
| Hamza Ahmed | 21/01/2026 | Muhammad Haris | 18/03/2026 |
|
| CMP-0016-26 | 22/01/2026 | QA | Permanent | Moderate | To implement microbiological assay testing on every batch of Cephalosporin suspension products. | Previously micro testing was performed on every tenth batch of Cephalosporin suspension products. | It is proposed to conduct micro testing on every batch of Cephalosporin suspension products. | N/A | Approved | 30/06/2026 | In Progress | Pharma | 01) Micro testing will be performed on each batch of suspension. QC(Micro)
02) SOP for "Microbiological Enumeration and Specified Micro-organisms Detection in Finished Products" (QCM/2/041) will be revise. QC(Micro)
|
| 01) June-26
02) June-26
| Hamza Ahmed | 22/01/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0017-26 | 22/01/2026 | QC | Permanent | Major | Procurement & Induction of a new semi micro balance Mettler Toledo Model: MA55. | Semi-Micro balance XSR105DU (Asset No. 1500000865) has experienced a critical hardware malfunction. The balance has been sent to the Vendor (Rauf Electronics) for diagnosis. Diagnosis indicates the failure of HMI device. | Semi-Micro balance XSR105DU (Asset No. 1500000865) will be traded off to Vendor (Rauf Electronics) for a new semi micro balance (Model: MA55). New equipment ID and asset number will be allotted as per procedure. | RA-0005-26-P | Approved | 31/08/2026 | In Progress | Pharma | 1) Asset trade form to be generated. (QC)
2) CAPEX of new semi micro balance to be generated. (QC)
03) IQ and OQ will be perform. (QC)
04) SOP will be prepared. (QC)
05) PQ will be perform. QA(Val)
06) Instrument list will be updated. (QC)
07) Calibration list will be updated. QA(Val)
| 01) Done
02) Done
| 01) Feb-26
02) March-26
03) July-26
04) July-26
05) July-26
06) July-26
07) Aug-26
| Hamza Ahmed | 22/01/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0018-26 | 23/01/2026 | Production | Permanent | Major | Tranferring of products to Hoonga Blister Machine Local CP | The products mentioned on the attached list are currently being blistered on 2DT blister machine as per mentioned dimensions (list attached). A/F 170mm & CFF 175mm. (List attached) | The Products mentioned on the attached list are agreed to move to the Hoonga Blister Machine as per mentioned dimensions (list attached). A/F 288mm & CFF 290mm. | N/A | Approved | 30/04/2027 | In Progress | Pharma | 01) Intimation to be submitted in DRAP. (RA)
02) Development and approval of artwork. (BD)
03) New item codes will be open. (BD)
04) Existing inventory will be consume. (SCM)
05) Procurement of packaging material. (SCM)
06) New tooling will be required. (Prod)
07) BOM will be revise in SAP. (QA)
08) BPR will be revise. (QA)
09) Process validation will be performed on blistering stage. QA(Val)
10) Specification will be update in SAP. (QC)
|
| 01) Dec-26
02) Nov-26
03) Nov-26
04) Dec-26
05) Nov-26
06) Oct-26
07) Dec-26
08) Dec-26
09) April-27
10) Dec-26
| Hamza Ahmed | 23/01/2026 | Muhammad Haris | 11/05/2026 |
|
| CMP-0019-26 | 23/01/2026 | SCM | Permanent | Minor | Change in Manufacturer name | We have approved manufacturer by the name of M/s. Venkata Narayana Active Ingredients Private Limited.
Address: Sy. No.69, Chandrapadiya Village, Vinjamur Mandal, S.P.S.R. Nellore District-524 228. Andhra Pradesh. | It is to proposed that manufacturer name has been changed to M/s. Chieron Active Ingredients Pvt. Ltd. Address: While the manufacturer site/material will remain same. | N/A | Approved | 31/03/2026 | Closed | Pharma | 01) Vendor list will be updated. (QA)
02) Vendor name will be updated in SAP. (QC)
| 01) Done
02) Done
| 01) March-26
02) March-26
| Hamza Ahmed | 23/01/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0020-26 | 30/01/2026 | SCM | Permanent | Major | Change of Name and manufacturing site for API Manufacturer M/S PRUDENCE PHARMA CHEM | We are currently procuring APIs Amlodipine Besylate, Febuxostat, Glimepiride from M/S PRUDENCE PHARMA CHEM located at Plot no. 7407, GIDC Estate, Ankleshwar- 393002, Bharuch, Gujarat, India. | Now manufacturer has changed their name to M/S Pridence Lifecare Pvt Ltd and site to a new WHO GMP certified facility which is located at plot no. 6104/6 GIDC industrial estate, Ankleshwar- 393002 Gujrat, India and will start supplying from new facility with new name from June, 2026 onwards. New site will be inducted in Pharmevo as per new details given. | N/A | Approved | 31/12/2028 | In Progress | Pharma | 01) Variation will be submitted in loacal and export countries. (RA)
02) Source approval documents from the new site will be submitted to QA. (SCM)
03) Vendor list will be updated by adding new vendor name and site and excluding previous name and site of the manufacturer. (QA)
04) New manufacturer name and site will be added in SAP and previous name and site will be deleted. (SCM)
05) Procurement of raw material form new site of the manufacturer. (SCM)
06) Process validation will be perform on three consecutive batches. QA(Val)
07) Stability will be perform on validation batches. (QC)
|
| 01)Dec-28
02) March-27
03) March-27
04) March-27
05) March-28
06) Dec-28
07) Dec-28
| Muhammad Haris | 30/01/2026 | Muhammad Haris | 19/03/2026 |
|
| CMP-0021-26 | 30/01/2026 | RA | Permanent | Minor | Change in batch size of SPS 100g Jar. | Currently batch size of SPS 100g SFG Jar is 35Kg. It is ready to fill product. | It is proposed to change this to flexible batch size to meet market demand. | N/A | Approved | 28/02/2026 | Closed | Pharma | 01) BDR will be revise. (QA)
| 01) Done
| 01) Feb-26
| Muhammad Haris | 30/01/2026 | Muhammad Haris | 18/03/2026 |
|
| CMP-0022-26 | 02/02/2026 | Production | Permanent | Moderate | Change of Pack size for local manufacturing of Xcept 15mg and 20mg tablet. | At present, the below mentioned products are blister on the BM-350 using 10's blister tooling. During operation, three blister pockets are intentionally left empty (Pic attached). The final pack configuration is 14's (2 x 7 tablets).
1. Xcept 15mg tab.
2. Xcept 20mg tab. | It is now proposed to utilize all blister pockets during blister operations on the BM-350. The existing blister tooling will be used without leaving any empty pocket. New pack size will be decided in change impact assessment. | N/A | Approved | 31/08/2026 | In Progress | Pharma | 01) Artwork will be develop as per 10’s pack size. (BD)
02) Item codes will be open. (BD)
03) Existing inventory will be consume. (SCM)
04) FG code will be open. (SCM)
05) Procurement of packaging material as per new approved artwork of pack size 10’s. (SCM)
06) BOM will be revise in SAP. (SCM)
07) BPR will be revise. (SCM)
08) Specifications will be update in SAP. (QC)
|
| 01) June-26
02) June-26
03) June-26
04) June-26
05) July-26
06) Aug-26
07) Aug-26
08) Aug-26
| Muhammad Haris | 02/02/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0023-26 | 02/02/2026 | Warehouse | Permanent | Minor | To change the format of GI, LC and MO in BDR and BPR. | In BDR,
1. In LC differential pressure of dispensing areas and laminar air pressure not mentioned.
2. In LC Expiry date of API is mentioned.
3. In MO, QC lot, Net qty issued, tare weight, gross weight , dispensed by, checked by, potency and adjustment are mention manually at the time of dispensing.
In SAP generated GI.
In GI columns with heading (To) (Balance) and (Status) are mentioned. | In BDR,
1. In LC differential pressure of dispensing areas and laminar air pressure will be added.
2. In LC Expiry date of API will be removed , as it is mentioned in GI.
3. In MO, QC lot, net qty issued, tare weight, gross weight, dispensed by, checked by, potency and adjustment will be removed because it is already part of GI.
In SAP generated GI
In GI columns with heading (To) (Balance) and (status) will be removed and further two columns with heading (dispensed by) (checked by) will be added GI.
| N/A | Approved | 31/12/2026 | In Progress | Pharma | 01) Changes will be made in SAP output form. (MIS)
02) UAT will be prepared. QA(Val)
03) PQ will be perform. QA(Val)
04) BDR will be revise. (QA)
|
| 01) June-26
02) June-26
03) July-26
04) Dec-26
| Muhammad Haris | 02/02/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0024-26 | 02/02/2026 | RA | Permanent | Minor | Spelling correction in the artwork of Aireez 4mg Sachet- Vietnam | A few spelling mistakes were identified in the DI of Aireez Sachet 4mg (Vietnamese Language). | The partner has requested correction of the spelling mistakes in the DI. | N/A | Approved | 30/04/2026 | Closed | Pharma | 01) Artwork will be revise. (BD)
02) New item code will be open. (BD)
03) Existing inventory will be write off. (SCM)
04) BOM will be revise in SAP. (QA)
05) Procurement of DI as per revised artwork. (SCM)
| 01) Done
02) Done
03) Done
04) Done
05) Done
| 01) Done
02) Done
03) Done
04) April-26
05) March-26
| Muhammad Haris | 02/02/2026 | Muhammad Haris | 22/06/2026 |
|
| CMP-0025-26 | 02/02/2026 | BD | Permanent | Major | Launch of New Product in Ghana. | The product mentioned below are not launched in Ghana yet.
Product: Galvecta Plus 50/500mg. Generic: Vildagliptin+ Metformin. Pack Size: 56's. Shelf Life: 24months. Registration Timeline: Registered.
Product: Galvecta Plus 50/1000mg. Generic: Vildagliptin+ Metformin. Pack Size: 56's. Shelf Life: 24months. Registration Timeline: Registered. | These products are planned for launch in Ghana. | RA-0045-25 | Approved | 31/08/2026 | In Progress | Pharma | 01) Registration letter required. (RA)
02) Product launch in Ghana. (BD)
03) Development and approval of artwork. (BD)
04) New item code will be open. (BD)
05) FG code will be open. (SCM)
06) BOM will be create in SAP. (QA)
07) BPR will be prepared. (QA)
08) Procurement of packaging material. (SCM)
09) Specification will be developed in SAP. (QC)
|
| 01) Done
02) Aug-26
03) Done
04) Done
05) Done
06) Aug-26
07) Aug-26
08) March-26
09) Aug-26
| Muhammad Haris | 02/02/2026 | Muhammad Haris | 11/05/2026 |
|
| CMP-0026-26 | 03/02/2026 | SCM | Permanent | Major | Alternate Vendor Qualification for Omeprazole Pellets from Vision Pharmaceutical (Pvt) Ltd. Site Address: Plot No: 22-23, Industrial Triangle Kahuta Road, Islamabad, Pakistan | Omeprazole pellets are currently procured from M/S Cohance Life Sciences and comply with the USP dissolution Test I. However, due to relocation and ongoing development of the supplier’s manufacturing facility, procurement from Cohance Life Sciences is currently not feasible.
Site Address: Plot No. A-19C, A-23A & A-23B, Road. No. 18, I.D.A., Nacharam, Medchal-Malkajgiri District- 500076, Telangana, India.
| It is proposed to procure omeprazole pellets from and alternate vendor i.e. Vision Pharmaceutical (Pvt) Ltd. to ensure continuity of supply. The proposed supplier claims compliance with USP specifications, with disolution meeting the USP requirement at Test II. | RA-0008-26-P | Approved | 30/11/2026 | In Progress | Pharma | 01) PD trial documents required. (PD)
02) Source approval document will be submitted to QA. (SCM)
03) Procurement of material from new source. (SCM)
04) Vendor list will be updated by adding new vendor name and site and excluding previous vendor name and site. (QA)
05) Artwork will be revise. (BD)
06) Item code will be open. (BD)
07) Process validation will be perform. QA(Val)
08) Stability will be perform on validation batches. (QC)
09) AMV will be perform. (PD)
10) Testing method will be revise. (QC)
11) Specification will be revise. (QC)
12) Source name will be added in SAP. (QC)
| 01) Done
02) Done
03) Done
04) Done
05) Done
06) Done
09) Done
10) Done
11) Done
12) Done
| 01) Done
02) Done
03) April-26
04) March-26
05) March-26
06) March-26
07) Nov-26
08) Nov-26
09) April-26
10) April-26
11) April-26
12) Done
| Muhammad Haris | 03/02/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0027-26 | 04/02/2026 | BD | Permanent | Moderate | To shift launched products in FWA region from country specific to Group (Shelf life specific) | Currently, products launched in FWA are categorized based on specific countries. | Products will be categorized into two groups based on shelf life instead of region/ countries:
1. FWA-A: 24 months
2. FWA-B: 36 months
Finished products codes will be created according to these groups.
Packaging material codes (A/F, U/C, D/I) will remain unchanged. | N/A | Approved | 30/04/2026 | Closed | Pharma | 01) FG code will be open. (SCM)
02) SCM will intimate QA for the updation of BOM. (SCM)
03) BOM will be revise in SAP. (QA)
| 01) Done
02) Done
03) Done
| 01) Done
02) March-26
03) April-26
| Muhammad Haris | 04/02/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0028-26 | 09/02/2026 | Warehouse | Permanent | Moderate | Change in the dispensing process of EHGC shell. | Currently, we dispensed EHGC shell in Kg but in MO EHGC shell mention in NOS and we also receive EHGC in NOs. As we know that EHGC are moisture sensitive, multiple time cartons are open for dispensing of EHGC shell and there is chance of shell damages due to edges of scoop. | We will dispense the MO quantity of EHGC shells in NOs as mentioned by vendor on the container. Only loose quantity will be dispensed in Kg. | N/A | Approved | 30/06/2026 | In Progress | Pharma | 01) UOM need to be change in SAP. (WH)
|
| 01) June-26
| Muhammad Haris | 09/02/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0029-26 | 12/02/2026 | QA | Permanent | Major | Change in finished product specification of Perabactum Injection range (1g IV/IM, 2g IV/IM) | Currently, Perabactum Injection Range specification is aligned as per Japanese Pharmacopoeia (JP). | It is proposed to revise finished product specifications of Perabactum Injection range from Japanese Pharmacopoeia (JP) specification to the Innovator's specifications. | N/A | Approved | 30/04/2026 | Closed | Pharma | 01) Item code will be open. (BD)
02) Old inventory will be destructed. (SCM)
03) Procurement of packaging material. (SCM)
04) BOM will be revise in SAP. (QA)
05) Testing method of RM and FG will be revise. (QC)
06) Stability specification will be updated. (QC)
07) Specification will be update in LIMS. (QC)
| 01) Done
02) Done
03) Done
04) Done
05) Done
06) Done
07) Done
| 01) Done
02) April-26
03) March-26
04) April-26
05) March-26
06) March-26
07) March-26
| Hamza Ahmed | 12/02/2026 | Muhammad Haris | 09/05/2026 |
|
| CMP-0030-26 | 12/02/2026 | QC | Permanent | Minor | Transfer of Stability Chamber responsibility from Quality Control to Product Development. | As per the current procedure, the Quality Control (QC) department is responsible for the maintenance and calibration of stability chamber 01, 02, 08, 10, 12 and 16, which are used by the Product Development (PD) department. | It is proposed that the responsibility for maintenance and calibration of stability chambers 01, 02, 08, 10, 12 and 16 is transferred to the Product Development (PD) department. | N/A | Approved | 30/06/2026 | In Progress | Pharma | 01) QC will transfer the responsibility of the stability chamber to PD. (QC)
02) QC will submit Chamber maintenance record and IQ, OQ documents to PD. (QC)
03) SOP of chamber will be prepared. (PD)
04) Log book will be prepred for placing samples in the stability chamber. (PD)
05) QC will update the instrument list by excluding the stability chambers 01, 02, 08, 10 and 12. (QC)
06) PD will update the instrument list by including the stability chambers 01, 02, 08, 10 and 12. (PD)
07) Calibration list will be update. QA (Val)
08) A new equipment ID for the stability chamber will be assigned for the Product Development Department. (Engineering)
| 01) Done
02) Done
| 01) March-26
02) March-26
03) June-26
04) June-26
05) June-26
06) June-26
07) June-26
08) June-26
| Muhammad Haris | 12/02/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0031-26 | 13/02/2026 | Warehouse | Permanent | Major | Development and implantation of Extended Warehouse Management. | Currently we are using SAP for inventory management and traceability through different reports. There is no proper visibility and traceability of stock in the warehouse. | We will develop and implement extended warehouse management (EWM) to enhance stock visibility and traceability in the warehouse. Furthermore it helps in optimization of process time and space utilization. | RA-0009-26-P | Approved | 30/06/2026 | In Progress | Pharma | 01) URS to be developed. (WH)
02) Development of EWMS in SAP. (WH)
03) Testing will perform in testing server. (WH)
04) IQ, OQ and PQ will perform. QA(Val)
| 01) Done
| 01) April-26
02) June-26
03) June-26
04) June-26
| Hamza Ahmed | 13/02/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0032-26 | 18/02/2026 | RA | Permanent | Major | Overprinting of QR matrix code on unit carton of Pharmaceutical and Nutraceutical products exporting to Tajikistan | Currently products exporting in Tajikistan only contain batch number, manufacturing date and expiry date on finished product. | It is proposed to carry out overprinting of QR matrix codes on the unit cartons of Pharmaceutical and Nutraceutical products intended for export to Tajikistan as per the following information. The QR matrix code will contain specific product information. This data will be provided by our partner inTajikistan in the form of an excel sheet. The data in the sheet will be converted in the form of data matrix code. The information will be unique to each individual unit carton and will be shared by the partner separately for each upcoming order destined for the Tajikistan market.
While following information will be printed in human readable form in the following format:
Batch No:
MFG:
EXP: | N/A | Approved | 31/07/2026 | In Progress | Pharma | 01) Specific product information in the form of excel sheet for the printing of QR matrix code will be provided. (RA)
02) Excel sheet data will be integrated with the pharmaTrax software for code management. (RA)
03) Tertiary packaging (Master carton) label will be generated through pharmTrax software containing all information of unit carton. (RA & Production)
04) Instruction will be incorporated in EPO. (SCM)
05) For every upcoming order for Tajikistan, (SCM) will inform immediately to RA for the issuance of verification code/Information in password protected sheet. (SCM & RA)
06) SOP to be developed for the QR code management for Tajikistan. (RA)
|
| 01) July-26
02) July-26
03) July-26
04) July-26
05) July-26
06) July-26
| Muhammad Haris | 18/02/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0033-26 | 20/02/2026 | SCM | Permanent | Moderate | Institution order of SHM Lowplat Plus. | Order of DGH Specialized order is received from institution market. | We have reviewed order of following products from PIC Bahawalpur Order:
Products: Lowplat Plus 75mg 1x10's. QTY: 1,000,000. Printing Requirements: BOMs will be opened with Pre-printed foil will be used with green commercial pack codes.
Order need to be provided with above mentioned artwork and pack size.
For Aluminium Foil:
Base color in green with Punjab Govt. Logo, "Punjab Govt Property" "Not for Sale" both in english and urdu. "SHC & MED"
For Green Box:
Green Box, product logo and detail, Traceable GTIN, Punjab Govt. Logo, "Punjab Govt Property" "Not for Sale" both in english and urdu, "Specialized Health Care & Medical Education Department Punjab" | N/A | Approved | 31/05/2026 | Closed | Pharma | 01) Development and approval of artwork. (BD)
02) Item code will be open. (BD)
03) FG code will be open. (SCM)
04) BOM will be created in SAP. (QA)
05) BPR will be prepared. (QA)
06) Specification will be updted in SAP. (QC)
| 01) Done
02) Done
03) Done
04) Done
05) Done
06) Done
| 01) March-26
02) March-26
03) March-26
04) May-26
05) May-26
06) May-26
| Muhammad Haris | 20/02/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0034-26 | 20/02/2026 | Production | Permanent | Minor | It is proposed to shift SPS Jar Ranges from manual labelling to auto labelling machine. | Currently, labelling process for SPS Jar Range is manual in general pharma. | It is proposed to shift SPS Jar Range from manual labelling to auto bottle labelling machine installed in packaging area for General Pharma. | N/A | Approved | 31/10/2026 | In Progress | Pharma | 01) Development and approval of artwork. (BD)
02) Item code will be open. (BD)
03) Old inventory will be consume. (SCM)
04) Procurement of new labels. (SCM)
05) BOM will be revise in SAP. (QA)
06) Specification will be update in SAP. (QC)
| 01) Done
02) Done
| 01) April-26
02) April-26
03) Oct-26
04) Aug-26
05) Aug-26
06) Aug-26
| Muhammad Haris | 20/02/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0035-26 | 25/02/2026 | Production | Permanent | Major | Addition of 3 new tablet de-duster (Model: SZS-750) | Currently, we have procured 3 new tablet de-dusters (Model: SZS-750) for compression use in production non-cephalosporin building. | It is proposed to add 3 newly procured tablet de-duster (Model: SZS-750) for compression machine (ZPW-23, ZPW-26 A & B) in compression section of production non-cephalosporin building. | RA-0011-26-P | Approved | 30/06/2026 | In Progress | Pharma | 01) DQ, IQ, OQ and PQ of equipment will be perform. QA(Val)
02) SOP will be revise. (Prod)
03) Training will be provided to concern person. (Prod)
04) Preventive maintenance plan will be update. (Eng)
05) Equipment list will be revise. (Eng)
|
| 01) June-26
02) June-26
03) June-26
04) June-26
05) June-26
| Muhammad Haris | 25/02/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0036-26 | 25/02/2026 | Production | Permanent | Major | Change in thickness limit. | Currently, the thickness limit of Avsar Plus 160/10/25mg tablet is 4.80mm (4.50-5.10)mm as per BMR specification. | It is proposed to revise the thickness limit of Avsar Plus 160/10/25mg tablet 4.70mm (4.30-5.10)mm to 5.30mm (4.90-5.70)mm as per improved hardness. | RA-0010-26-P | Approved | 30/09/2026 | In Progress | Pharma | 01) BMR will be revise. (QA)
02) Testing method will be revise. (QC)
03) Process validation will be perform on three batches. QA(Val)
04) Stability will be perform on validation batches. (QC)
05) Specification will be update in SAP. (QC)
| 01) Done
02) Done
05) Done
| 01) April-26
02) April-26
03) Sep-26
04) Sep-26
05) April-26
| Muhammad Haris | 25/02/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0037-26 | 26/02/2026 | Production | Permanent | Major | Transferring of products to Hoonga Blister Machine Local CP. | The products mentioned on the attached list are currently blistered on BM 350 blister machine as per mentioned dimensions (list attached). A/F 266mm & CFF 268mm. List attached. | The products mentioned on the attached list are agreed to move to the Hoonga Blister Machine as per mentioned dimensions (list attached). A/F 288mm & CFF 290mm | N/A | Approved | 30/06/2027 | In Progress | Pharma | 01) Intimation to be submitted in DRAP. (RA)
02) Development and approval of artwork. (BD)
03) New item codes will be open. (BD)
04) Existing inventory will be consume. (SCM)
05) Procurement of packaging material. (SCM)
06) New tooling will be required. (Production)
07) BOM will be revise in SAP. (QA)
08) BPR will be revise. (QA)
09) Process validation will be performed on blistering stage. QA (Val)
10) Specifications will be update on SAP. (QC)
|
| 01) Nov-26
02) Oct-26
03) Oct-26
04) Nov-26
05) Nov-26
06) Sep-26
07) Dec-26
08) Dec-26
09) June-27
10) Dec-26
| Muhammad Haris | 26/02/2026 | Muhammad Haris | 11/05/2026 |
|
| CMP-0038-26 | 27/02/2026 | RA | Permanent | Minor | Change of Finished Product Specification for Pregab-Q (Pregablin) 25mg & 75mg Capsules from In-House to BP. | The existing specifications for Pregab-Q (Q-Pharma, Kenya) is in-house. | New Specifications approved for Pregab-Q (Q-Pharma, Kenya) is BP. | N/A | Approved | 30/06/2026 | In Progress | Pharma | 01) Development and approval of artwork (A/F, U/C and DI). (BD)
02) Item code will be open. (BD)
03) BOM will be update in SAP. (QA)
04) Specification will be update in SAP. (QC)
|
| 01) June-26
02) June-26
03) June-26
04) June-26
| Muhammad Haris | 27/02/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0039-26 | 27/02/2026 | SCM | Permanent | Minor | Addition of Supplier for Local Materials. | Currently, we are procuring Iso Propyl Alcohol (IPA) from supplier as per attached sheet. | It is proposed to add one more supplier "Mars Chemicals (Private) Limited" Address: 805, Anum Estate, Shahrah-e-Faisal, Karachi.
For the procurement of above mentioned materials from the same approved manufacturer's as mentioned in attached list. | N/A | Approved | 30/04/2026 | Closed | Pharma | 01) Approved vendor list will be update. (QA)
02) Supplier name will be added in SAP. (SCM)
| 01) Done
02) Done
| 01) April-26
02) April-26
| Muhammad Haris | 27/02/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0040-26 | 27/02/2026 | SCM | Permanent | Minor | Addition of Supplier for Local Materials. | Currently, we are procuring Iso Propyl Alcohol (IPA) USP, Methylene Chloride from supplier as per attached sheet. | It is proposed to add one more supplier "Cheminova Corporation" Address: Plot No. 10, Block 7/8 KMCHS, near Hill Park, Karachi.
For the procurement of above mention material from the Approved Manufacturer, LCY Taiwan, Inovyn Chlor Ltd, Ineos Chlor Ltd, Integrated Commercial Ventures (ICV) China.
| N/A | Approved | 30/04/2026 | Closed | Pharma | 01) Approved vendor list will be update. (QA)
02) Supplier name will be added in SAP. (SCM)
| 01) Done
02) Done
| 01) April-26
02) April-26
| Muhammad Haris | 27/02/2026 | Muhammad Haris | 09/05/2026 |
|
| CMP-0041-26 | 04/03/2026 | PD | Permanent | Major | New launch product Bethanechol Chloride 10mg and 25mg tablet. | Product development activities of generic Bethanechol Chloride 10mg and 25mg tablet has been completed. | It is proposed to commercialize Bethanechol Chloride 10mg and 25mg tablet in pharmevo facility.
Batch size for Bethanechol Chloride 10mg is 100,000 tablet (20kg)
Batch size for Bethanechol Chloride 25mg is 50,000 tablet (25kg) | RA-0012-26-P | Approved | 31/03/2027 | In Progress | Pharma | 01) Trail documents required. (PD)
02) Stability study documents required (three months accelerated and long term stability). (PD)
03) Containment approach report is required. (PD)
04) Cleanibility report is required. (PD)
05) Technology transfer protocol (for process) is required. (PD)
06) Technology transfer protocol (for analytical testing) is required. (PD)
07) Source approval documents will be sumitted to QA. (SCM)
08) Procurement of raw material. (SCM)
09) Artwork will be develop and approved. (BD)
10) Item code will be open for new develop artwork. (BD)
11) Procurement of packaging material. (SCM)
12) Analytical testing method will be prepare. (QC)
13) BOM will be create in SAP. (QA)
14) Batch documents (BDR, BMR and BPR) will be prepared. (QA)
15) Routing will be create in SAP. (Production)
16) Planning of product launch for commercial. (BD)
17) Process Validation will be perform. QA (Val)
18) Hold Time Study will be perform. QA (Val)
19) Assessment will be perform for cleaning validation. QA (Val)
20) Product will be charge on stability study. (QC)
| 01) Done
02) Done
| 01) Done
02) Done
03) June-26
04) June-26
05) June-26
06) June-26
07) July-26
08) Aug-26
09) June-26
10) June-26
11) Aug-26
12) Aug-26
13) aug-26
14) Aug-26
15) Aug-26
16) Aug-26
17) Dec-26
18) March-27
19) Dec-26
20) Dec-26
| Hamza Ahmed | 04/03/2026 | Muhammad Haris | 19/06/2026 |
|
| CMP-0042-26 | 06/03/2026 | QC | Permanent | Major | Addition of new Thin Layer Chromatography appratus in QC laboratory (Non Ceph Area) | Currently QC lab do not have TLC appratus for identification test. | It is proposed to procure an apparatus for Thin Layer Chromatography in the Quality control Laboratory.
S.No: 01. Equipment Name: Thin Layer Chromatography Apparatus. Vendor: IMCO. Make: Local. Quantity: 01. | RA-0013-26-P | Approved | 30/06/2026 | In Progress | Pharma | 01) SOP for Thin Layer Chromatography Plate will be develop. (QC)
02) Training will be provided to concern staff. (QC)
|
| 01) June-26
02) June-26
| Muhammad Haris | 06/03/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0043-26 | 13/03/2026 | BD | Permanent | Major | Launch of new products in French West Africa. | The products mentioned below are not launched in French West Africa.
S.No. 01. Product: Glyzempa 10mg tablet. Generic: Empagliflozin. Pack Size: 4x7's. Shelf Life: 24months. Registration Timeline: Registered.
S.No. 02. Product: Glyzempa 25mg tablet. Generic: Empagliflozin. Pack Size: 4x7's. Shelf Life: 24months. Registration Timeline: Registered. | These products are planned for launch in French West Africa. | RA-0045-25 | Approved | 31/07/2026 | In Progress | Pharma | 01) Planning of product launch for commercial. (BD)
02) Development and approval of artwork. (BD)
03) Item code will be open. (BD)
04) FG code will be open. (SCM)
05) BOM will be create in SAP. (QA)
06) BPR will be prepared. (QA)
07) Procurement of packaging material. (SCM)
08) Specification will be developed in SAP. (QC)
|
| 01) July-26
02) Done
03) Done
04) May-26
05) July-26
06) July-26
07) Subjected to order
08) July-26
| Muhammad Haris | 12/03/2026 | Muhammad Haris | 11/05/2026 |
|
| CMP-0044-26 | 12/03/2026 | PD | Permanent | Major | Manufacturing of batches for submission of WHO dossier of Spectrix 250mg and 500mg tablets with improved formulation. | Product development activities of Spectrix 250mg and 500mg tablets with improved formulation has been completed. | It is proposed to manufacture three batches of Spectrix 250mg and 500mg from API manufacturer "Shangyu Jingxin Pharmaceutical CP Ltd" in Pharmevo facility. Proposed batch size will be as follows:
1) Spectrix 250mg tablet: 150,515 tablets
2) Spectrix 500mg tablets: 50,000 tablets | RA-0016-26-P | Approved | 31/05/2027 | In Progress | Pharma | Spectrix 250mg Tablets:
01) Lab scale trial will be performed. (PD)
02) Trial batch will be charge on stability. (PD)
03) Regulatory will submit the variation in DRAP for change in formulation (Batch will be manufacture after approval) (RA)
04) Technology transfer protocol (for process) will be developed. (PD)
05) Technology transfer protocol (for analytical testing) will be developed. (PD)
06) Placebo sample will be submitted to QC for AMV. (PD)
07) AMV will be performed for both raw material and finished product. (QC)
08) Batches of Spectrix 250mg tablet will be manufacture with old formulation to cover six month market requirement. (SCM)
09) New API code will be open with the name Levofloxacin Hemihydrate (WHO Grade). (SCM)
10) Quantity of Levofloxacin (150.00Kg) will be transferred to new opened code of API from PD code. (WH)
11) Manual inspection lot will be created. (QC)
12) Raw material impurity will be procured. (QC)
13) Impurity testing will be performed for both raw material and finished product. (QC)
14) Testing of Levofloxacin from manufacturer "Shangyu Jingxin Pharmaceutical CP Ltd" will be perform. (QC)
15) Compression tooling will be procured for Spectrix 250mg tablet. (Production)
16) Review of artwork as per the WHO requirement. (BD & RA)
17) Revision of artwork if required. (BD & RA)
18) SFG BOM will be revised as per new formulation. (QA)
19) Availability of all required raw and packaging materials as per BOM for three batches. (SCM)
20) Batch documents will be prepared. (QA)
21) Blister operation will be performed on BM-350B machine and only BM-350B machine is the part of BPR. (Production)
22) Routing will be create in SAP. (Production)
23) Planning of spectrix 250mg tablet batches. (SCM)
24) Manufacturing of Spectrix 250mg tablet batches. (Production)
25) NDMA/ NDEA samples will be collected and submitted to QC. (QA)
26) QC will send these samples for outsource testing. (QC)
27) Process validation will be performed. QA (Val)
28) Hold time study will be performed. QA (Val)
29) Cleaning validation will be performed. QA (Val)
30) Product will be charge on stability. QC
31) Dossier will be prepared and submitted. (RA)
Spectrix 500mg Tablets:
01) LAb scale trial will be performed. (PD)
02) Trial batch will be charge on stability. (PD)
03) Regulatory will submit the variation in DRAP for change in formulation (Batch will be manufacture after approval). (RA)
04) Technology transfer protocol (for process) will be developed. (PD)
05) Technology transfer protocol (for analytical testing) will be developed. (PD)
06) Placebo sample will be submitted to QC for AMV. (PD)
07) AMV will be performed for both raw material and finished product. (QC)
08) Batches of Spectrix 500mg tablet will be manufacture with old formulation to cover six month market requirement. (SCM)
09) New API code will be open with name Levofloxacin Hemihydrate (WHO Grade)
10) Quantity of Levofloxacin (150.00Kg) will be transferred to new opened code of API from PD code. (WH)
11) Manual inspection lot will be created. (QC)
12) Raw material impurity will be procured. (QC)
13) Impurity testing will be performed for both raw and finshed product.(QC)
14) Testing of Levofloxacin from manufacturer “Shangyu Jingxin Pharmaceutical CP Ltd” will be perform. (QC)
15) Review of artwork as per the WHO requirement. (BD& RA)
16) Revision of artwork if required. (BD & RA)
17) SFG BOM will be revised as per new formulation. (QA)
18) Availability of all required raw and packaging materials as per BOM for three stability batches. SCM
19) Batch documents will be prepared. QA
20) Blister operation will be performed on BM-350B machine and only BM-350B machine is the part of BPR. (Production)
21) Routing will be create in SAP. (Production)
22) Planning of Spectrix 500mg tablet batches. SCM
23) Manufacturing of spectrix 500mg tablet batches. Production
24) NDMA/NDEA samples will be collected and submitted to QC. QA
25) QC will send these samples for outsource testing. QC
26) Process validation will be performed. QA(Val)
27) Hold time study will be performed. QA(Val)
28) Cleaning validation will be performed. QA(Val)
29) Product will be charge on stability. QC
30) Dossier will be prepared and submitted. RA
|
| Spectrix 250mg Tablet:
01) June-26
02) June-26
03) June-26
04) June-26
05) June26
06) June-26
07) June-26
08) June-26
09) June-26
10) June-26
11) June-26
12) June-26
13) July-26
14) Aug-26
15) Aug-26
16) Aug-26
17) Aug-26
18) Sep-26
19) Sep-26
20) Sep-26
21) Sep-26
22) Sep-26
23) Oct-26
24) Oct-26
25) Oct-26
26) Oct-26
27) March-27
28) May-27
29) March-27
30) March-27
31) April-27
Spectrix 500mg Tablet:
01) June-26
02) June-26
03) June-26
04) June-26
05) June-26
06) June-26
07) June-26
08) June-26
09) June-26
10) June-26
11) June-26
12) June-26
13) July-26
14) Aug-26
15) Aug-26
16) Aug-26
17) Sep-26
18) Sep-26
19) Sep-26
20) Sep-26
21) Sep-26
22) Oct-26
23) Oct-26
24) Oct-26
25) Oct-26
26) March-27
27) May-27
28) March-27
29) March-27
30) April-27
| Muhammad Haris | 12/03/2026 | Muhammad Haris | 17/06/2026 |
|
| CMP-0045-26 | 24/03/2026 | SCM | Temporary | | Redressing of Finished Products Intended for Afghanistan Market to Local CP. | Finished products were manufactured and labeled for export to Afghanistan due to suspension of trade relations and export restriction, distribution is no longer permitted, rendering the stock unusable in its current form. Additionally, certain batches were parttially released earlier in local CP, necessitating clear identification and traceability of remaining quantities.
| To redress the existing stock through controlled relabelling and/ or repackaging in compliance with local regulatory requirements (refer attached list of finished products). For partially released batches, a defined suffix "R" will be appended to the batch numbewr to ensure identification, segregation, and traceability of redressed quantities. (E.g: Batch Number 5J001 will be 5J001R) and this batch number will be printed on unit carton only. | N/A | Close without implementation. | | Closed | Pharma |
|
|
| Muhammad Haris | 24/03/2026 | Muhammad Haris | 09/05/2026 |
|
| CMP-0046-26 | 24/03/2026 | SCM | Permanent | Major | Additional source induction of Orlistat Pellets 50%. | We have approved sources for Orlistat Pellets 50% as M/S ALPHAMED FORMULATION PVT. LTD & Surge Labs Pvt Ltd. | We intend to induct one more source M/s. Biocon Limited. Address: Special Economic Zone Plot no. 2, 3, 4 & 5, Phase IV Bommasandra-Jigani Link Road, Bommasandra post Bengaluru-560099 Karnataka, INDIA. | N/A | Approved | 31/12/2026 | In Progress | Pharma | 01) Source approval documents will be submitted to QA. (SCM)
02) Procurement of material from new source. (SCM)
03) Vendor list will be update. (QA)
04) Source name will be added in SAP. (QA)
05) Process validation will be perform. QA(Val)
06) Stability will be perform on validation batches. (QC)
|
| 01) June-26
02) Aug-26
03) June-26
04) June-26
05) Dec-26
06) Dec-26
| Muhammad Haris | 24/03/2026 | Muhammad Haris | 17/06/2026 |
|
| CMP-0047-26 | 25/03/2026 | PD | Permanent | Major | Manufacturing of Zi-AD tablet 5mg for submission of dossier in WHO as per EOI | Currently, Zi-AD 20mg Dispersible tablet is prequalified in WHO with WHO reference number (D1009) | It is proposed to manufacture Zi-AD 5mg Dispersible tablet in Pharmevo as per WHO expression of interest with source of Zinc Sulphate as Canton Labourtries Pvt Ltd. The tablet weight is increase from 95mg/tablet to 120mg/tablet. The tablet is compressed at 7.00mm punch. | RA-0017-26-P | Approved | 31/12/2026 | In Progress | Pharma | 01) Orange Trusil Flavor Powder Sc085569 Tab will be procured. SCM
02) Analytical and micro testing will be performed for Orange Trusil Flavor Powder Sc085569 Tab. QC
03) PD trial document is required along with the analytical report. PD
04) Placebo and sample will be submitted to QC for AMV. PD
05) Method verification to be performed. QC
06) Technology transfer protocol(for process) will be developed. PD
07) Technology transfer protocol(for analytical testing) will be developed. PD
08) New punches(Fette Compression machine) will be procured. Production
09) Blister tubes will be procured. Production
10) Verification of punches and tubes will be performed. Production/PD
11) Artwork will be revised.(U/C, D/I,A/F) BD
12) New item code will be opened for the revised artwork. BD
13) Procurement of material as per revised artwork. SCM
14) New item code will be open for the API, Excipients and primary packaging material by mentioning the manufacturer name. SCM & BD
15) BOM will be created in SAP. QA
16) Batch Documents will be revised. QA
17) Availibilty of raw and packaging material.
SCM
18) Planning of Zi-AD batches for dispensing.
SCM
19) Manufacturing of Zi-AD batches. Production
20) Submission of finished product samples to QC for NDMA/NDEA testing. QA
21) QC will send these sample for outsource testing of NDMA/NDEA. QC
22) Process validation will be performed QA(Val)
23) Product will be charge on stability. QC
24) Cleaning validation will be performed. QA(Val)
25) Hold time study will be performed. QA(Val)
26) Batch will be hold till six month stability results. QA
27) Dossier will be prepared and submitted in DRAP RA
28) Dossier will be prepared and submitted in WHO. RA
| 01) Done
02) Done
03) Done
04) Done
05) Done
06) Done
07) Done
08) Done
09) Done
10) Done
11) Done
12) Done
13) Done
14) Done
15) Done
16) Done
17) Done
| 01) April-26
02) April-26
03) April-26
04) April-26
05) April-26
06) May-26
07) May-26
08) May-26
09) May-26
10) June-26
11) May-26
12) May-26
13) May-26
14) May-26
15) May-26
16) May-26
17) May-26
18) July-26
19) July-26
20) July-26
21) July-26
22) July-26
23) July-26
24) July-26
25) Nov-26
26) Nov-26
27) Dec-26
28) Dec-26
18) June-26
19) Sep-26
| Hamza Ahmed | 25/03/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0048-26 | 25/03/2026 | PD | Permanent | Major | Manufacturing of Zi-AD syrup 5mg/5ml for submission of dossier in WHO as per EOI | Currently, Zinc Sulphate Oral Solution is pre qualified in WHO having WHO reference number (D1010) being manufactured with source Zinc Sulphate as DR. Paul Lohman GMBH. KG source. | It is proposed to develop Zinc Sulphate Oral Solution in Pharmevo as per WHO Expression of Intrest with source of Zinc Sulphate as Canton Labourtries Pvt. Ltd | RA-0018-26-P | Approved | 31/08/2026 | In Progress | Pharma | 01) Orange Trusil Flavor Powder SN942166 Syp will be procured. SCM
02) Analytical and micro testing will be performed for Orange Trusil Flavor Powder Sc085569 Tab. QC
03) Placebo and sample will be submitted to QC for AMV. PD
04) Method verification to be performed. QC
05) Artwork will be revised(U/C, label and D/I) BD
06) New item code will be opened for the revised artwork. BD
07) Procurement of material as per revised artwork. SCM
08) New item code will be open for the API and Excipients by mentioning the manufacturer name. SCM
09) BOM will be revised in SAP. QA
10) Batch Documetns will be revised. QA
11) Availibilty of raw and packaging material.
SCM
12) Planning of Zi-AD batches for dispensing.
SCM
13) Manufacturing of Zi-AD batches. Production
14) Submission of finished product samples to QC for NDMA/NDEA and DEG/EG testing. QA
15) QC will send these sample for outsource testing of NDMA/NDEA and DEG/EG. QC
16) Process validation will be performed QA(Val)
17) Product will be charge on stability. QC
18) Leaching study will be performed for primary packaging material. QC
19) In use stability studies will be performed. QC
20) Hold time study will be performed. QA(Val)
21) Cleaning verification will be performed. QA(Val)
22) Batch will be hold till six month stability results. QA
23) Dossier will be prepared and submitted in DRAP. RA
24) Dossier will be prepared and submitted in WHO. RA
| 01) Done
02) Done
03) Done
05) Done
| 01) April-26
02) April-26
03) April-26
04) May-26
05) May-26
06) May-26
07) May-26
08) May-26
09) May-26
10) May-26
11) May-26
12) June-26
13) July-26
14) July-26
15) July-26
16) July-26
17) July-26
18) July-26
19) July-26
20) July-26
21) July-26
22) July-26
23) Aug-26
24) Aug-26
| Hamza Ahmed | 25/03/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0049-26 | 27/03/2026 | SCM | Permanent | Moderate | Institution order of CPEIC WIC Wazirabad Institute. | Order of CPEIC WIC Wazirabad Institute is received from institution market. | We have recieved order of following products from CPEIC WIC Wazirabad Institute Faisalabad:
Products: Evopride Tab. 4mg Inst. DGH 3x10's. Qty: 6,668. Printing Requirements: Green Unit Carton will be arranged and in-house printing will be done as per requirement of institution.
Order need to be provided with below mentioned artwork and pack size.
For Aluminium Foil:
Base color in green (Not mandatory) with Punjab Govt. logo, " CPEIC Wazirabad" (Not mandatory), "Punjab Govt Property" "Not for Sale".
For Green Box:
Green Box, product logo and details, Traceable GTIN, Punjab Govt. Logo, "CPEIC Wazirabad" "Punjab Govt Property" "Not for Sale" both in english and urdu. | N/A | Approved | 30/04/2026 | In Progress | Pharma | 01) Development and approval of artwork. (BD)
02) Item code will be open. (BD)
03) FG code will be open. (SCM)
04) BOM will be create in SAP. (QA)
05) BPR will be prepare. (QA)
06) Specifications will be update in SAP. (QC)
| 01) Done
02) Done
03) Done
04) Done
05) Done
06) Done
| 01) Done
02) Done
03) April-26
04) April-26
05) April-26
06) April-26
| Muhammad Haris | 27/03/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0050-26 | 30/03/2026 | BD | Permanent | Major | Launch of New Products in Sri Lanka | The products mentioned below are not launched in Sri Lanka yet.
S.No: 01. Products: Arbi-H Tab. 300+12.5mg. Generic: Irbesartan+ HCTZ. Pack Size. 1x10's. Shelf Life: 24 months. Registration Timeline: May-26.
S.No: 02. Products: Arbi-H Tab. 300+25mg. Generic: Irbesartan+ HCTZ. Pack Size. 2x7's. Shelf Life: 24 months. Registration Timeline: May-26.
S.No: 03. Products: Arbi-H Tab. 150+12.5mg. Generic: Irbesartan+ HCTZ. Pack Size. 1x10's. Shelf Life: 24 months. Registration Timeline: May-26. | These products are planned for launch in Sri Lanka | RA-0045-25 | Approved | 30/11/2026 | In Progress | Pharma | 01) Registration is required. (RA)
02) Product launch in Srilanka. (BD)
03) Development and approval of artwork. (BD)
04) Item code of packaging material will be open. (BD)
05) FG code will be open. (SCM)
06) BOM will be create in SAP. (QA)
07) BPR will be prepare. (QA)
08) Procurement of packaging material. (SCM)
09) Specification will be develop in SAP. (QC)
|
| 01) June-26
02) Nov-26
03) Done
04) Done
05) May-26
06) Aug-26
07) Aug-26
08) Based on sales order.
09) Aug-26
| Muhammad Haris | 30/03/2026 | Muhammad Haris | 11/05/2026 |
|
| CMP-0051-26 | 30/03/2026 | BD | Permanent | Major | Launch of New Products in French West Africa. | The products mentioned below are not launched in French West Africa (FWA-A) yet.
S.No. 01. Products: Galvecta Plus Tab. 50+1000mg. Generic: Vildagliptin+ Metformin. Pack Size: 4x7's. Shelf Life: 24 months. Registration Timeline: Registered.
S.No. 02. Products: Galvecta Plus Tab. 50+850mg. Generic: Vildagliptin+ Metformin. Pack Size: 4x7's. Shelf Life: 24 months. Registration Timeline: Registered.
S.No. 03. Products: Galvecta Tab. 50mg. Generic: Vildagliptin+ Metformin. Pack Size: 3x10's. Shelf Life: 24 months. Registration Timeline: Registered. | These products are planned for launch in French West Africa | RA-0045-25 | Approved | 31/08/2026 | In Progress | Pharma | 01) Product launch in French West Africa. (BD)
02) Development and approval of artwork. (BD)
03) Item code of packaging material will be open. (BD)
04) FG code will be open. (SCM)
05) BOM will be create in SAP. (QA)
06) BPR will be prepare. (QA)
07) Procurement of packaging material. (SCM)
08) Specification will be develop in SAP. (QC)
|
| 01) Aug-26
02) Done
03) Done
04) May-26
05) Aug-26
06) Aug-26
07) Based on sales order
08) Aug-26
| Muhammad Haris | 30/03/2026 | Muhammad Haris | 11/05/2026 |
|
| CMP-0052-26 | 30/03/2026 | BD | Permanent | Moderate | Launch of Histalis (Ebastine) 60ml Solution in Local Market through Contract Manufacturing. | Histalis (Ebastine) 60ml solution is not launched in the local market yet.
| Histalis (Ebastine) 60ml Solution is planned for launch in the Local Market through Contract Manufacturing.
Brand Name: Histalis 5mg/5ml Liquid. Generic Name: Ebastine. Dosage Form: Syrup (PET Bottle). Strength: 5mg/5ml. Pack Size (CP): 60ml. Shelf Life: 24 months. Name of Contract Manufacturer: Titlis Pharma (Pvt) Ltd. | N/A | Approved | 31/08/2026 | In Progress | Pharma | 01) Planning of product launch through contract manufacturing. (BD)
02) Development and approval of artwork. (BD)
03) New FG code will be open. (SCM)
04) Standard testing method will be required from contract manufacturer. (QA)
05) List of contract manufacturing will be update. (QA)
|
| 01) Aug-26
02) May-26
03) May-26
04) July-26
05) July-26
| Muhammad Haris | 30/03/2026 | Muhammad Haris | 23/04/2026 |
|
| CMP-0053-26 | 30/03/2026 | QC | Permanent | Major | Revision of Testing methods specification of Finish Product from In-house to Pharmacopeia (USP) | Following products are based on in-house specification as their testing method was not available in USP, BP and JP Pharmacopeia.
01) Dapwiz Tablet 5mg.
02) Dapwiz Tablet 10mg. | The products listed above will be official in United State Pharmacopeia from 01-06-2026. | RA-0021-26-P | Approved | 30/09/2026 | In Progress | Pharma | 01) Variation will be applied in DRAP. (RA)
02) Development and approval of artwork. (BD)
03) Item code will be open. (BD)
04) Old codes of packaging material will be block for procurement. (SCM)
05) Old inventory will be consume. (SCM)
06) Method verification will be perform. (QC)
07) Testing method will be develop as per USP. (QC)
08) BOM will be revise in SAP. (QA)
09) BPR will be prepared. (QA)
10) Packaging specification will be revise in SAP. (QC)
|
| 01) June-26
02) June-26
03) June-26
04) April-26
05) Aug-26
06) June-26
07) June-26
08) Sep-26
09) Sep-26
10) Sep-26
| Muhammad Haris | 30/03/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0054-26 | 01/04/2026 | RA | Permanent | Major | Change of Finished Product Specifications for X-Plended 5mg, 10mg & 20mg and Inosita 100mg from In-house to USP in Srilanka. | The existing specifications for X-Plended 5mg, 10mg & 20mg and Inosita 100mg is In-house for Srilankan market. | New specifications approved for X-Plended 5mg, 10mg & 20mg and Inosita 100mg is USP for Srilankan market. | RA-0021-26-P | Approved | 31/08/2026 | In Progress | Pharma | 01) Approval is required from NMRA. (RA)
02) Artwork will be revise. (BD)
03) Item code will be open. (BD)
04) Old codes of packaging material will be block for procurement. (SCM)
05) Old inventory will be consume. (SCM)
06) Procurement of packaging material. (SCM)
07) BOM will be revise in SAP. (QA)
08) Specification will be update in SAP. (QC)
|
| 01) Done
02) June-26
03) June-26
04) May-26
05) July-26
06) Aug-26
07) Aug-26
08) Aug-26
| Muhammad Haris | 01/04/2026 | Muhammad Haris | 12/06/2026 |
|
| CMP-0055-26 | 06/04/2026 | SCM | Permanent | Major | Additional source induction of Valsartan. | We have existing sources of Valsartan M/S ZHEJIANG TIANYU & ZHEJIANG HUAHAI PHARMACEUTICAL & ZHUHAI RUNDU PHARMA. | We intend to induct one more source M/s. Anhui Menovo Pharmaceutical Co., Ltd.
Address: No. 125 and No. 202, 242299, Zhongshan Road, Economic Development Zone, Guangde City, Xuancheng City, Anhui Province, China | N/A | Approved | 31/12/2026 | In Progress | Pharma | 01) Source approval documents will be submitted to QA. (SCM)
02) Procurement of material from new source. (SCM)
03) Vendor list will be update. (QA)
04) Source name will be added in SAP. (QA)
05) Process validation will be perform. QA(Val)
06) Stability will be perform on validation batches. (QC)
| 01) Done
03) Done
| 01) April-26
02) July-26
03) May-26
04) May-26
05) Dec-26
06) Dec-26
| Muhammad Haris | 06/04/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0056-26 | 15/04/2026 | SCM | Permanent | Major | Revision of batch manufacturing date determination criteria (Dispensing to Granulation Basis). | The manufacturing date of the batch is currently determined based on the batch dispensing date. | The manufacturing date of a batch will be determined based on the 1st manufacturing process i.e Granulation. | RA-0023-26-P | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 15/04/2026 | Muhammad Haris | 07/05/2026 |
|
| CMP-0057-26 | 15/04/2026 | QC | Permanent | Major | Addition of 15 new HPLCs in QC laboratory (General Pharma). | Currently, QC Lab- General Pharma (Non-Ceph) has 23 HPLCs of various makes for testing of raw material, finished products and stability products.
S.No: 01. Instrument Name: HPLC. Quantity: 23. Make: Shimadzu/ Thermo Scientific/ Agilent. | It is proposed that 15 new HPLCs will be installed in QC Lab- General Pharma (Non-Ceph).
S.No: 01. Instrument Name: HPLC. Quantity: 06. Make: Shimadzu. S.No: 02. Instrument Name: HPLC. Quantity: 09. Make: Thermo Scientific. | RA-0024-26-P | Approved | 30/06/2026 | In Progress | Pharma | 01) IQ, OQ and PQ of all instruments will be perform. (QC)
02) SOP of all instruments will be prepared. (QC)
03) Training will be provided to concern person. (QC)
04) Instrument list will be updated. (QC)
| 01) Done
02) Done
| 01) May-26
02) May-26
03) June-26
04) June-26
| Muhammad Haris | 15/04/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0058-26 | 04/05/2026 | QC | Permanent | Moderate | Shifting from manual inventory management of stability samples to SAP inventory module. | Currently, inventory of stability samples are allocated in the excel sheet of sample inventory of stability samples as per the SOP of stability studies QCG/5/016. | Now, it is proposed to transfer the manual inventory management system to SAP inventory management. | N/A | Approved | 31/08/2026 | In Progress | Pharma | 01) URS will be prepared. (QC)
02) OQ and PQ will be perform. QC & QA (Val)
03) UAT will be perform. QC & QA (Val)
04) SOP of "Stability Studies Program" (QCG/2/016) will be revise. (QC)
05) SOP of SAP inventory module will be prepared and training will be provided to concern person.
|
| 01) June-26
02) July-26
03) July-26
04) July-26
05) Aug-26
| Muhammad Haris | 04/05/2026 | Muhammad Haris | 01/06/2026 |
|
| CMP-0059-26 | 05/05/2026 | SCM | Permanent | Moderate | Institution order of DGDP (Defence forces of Pakistan) | Order of DGDP Army is received from institution market. | We have reviewed order of following product DGDP Order:
Products: Anplag Tab. 90mg Inst. DGDP CP 20's. Qty: 22,500 Packs. Printing Requirements: BOMs will be opened with Pre-printed foil will be used with special printed commercial box. | N/A | Approved | 30/06/2026 | In Progress | Pharma | 01) Development and approval of artwork. (BD)
02) Item code will be open. (BD)
03) FG code will be open. (SCM)
04) BOM will be created in SAP. (QA)
05) BPR will be prepared. (QA)
06) Specification will be updated in SAP. (QC)
|
| 01) Done
02) Done
03) May-26
04) June-26
05) June-26
06) June-26
| Muhammad Haris | 05/05/2026 | Muhammad Haris | 12/06/2026 |
|
| CMP-0060-26 | 05/05/2026 | SCM | Permanent | | Implementation of Supplier Evaluation System in SAP. | Currently our system does not include a structured supplier evaluation mechanism, supplier performance and are assessed without standardized criteria. | Integration of a Supplier Evaluation System within SAP to ensure consistent and transparent assessment of suppliers based on material quality, on time delivery, payment term, price, technical support & emergency responsiveness. | N/A | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 05/05/2026 | Muhammad Haris | 05/05/2026 |
|
| CMP-0061-26 | 05/05/2026 | Engineering | Permanent | Major | Replacement of all existing door shutters only in General Pharma (Non-Ceph) production floor. | Currently, there are doors installed at production floor of General Pharma (Non-Ceph) having fiber material inside while covered with color coating in order to ensure the GMP compliance and its smooth cleaning these doors are deteriorating day by day and require frequent maintenance work due to frequent paint peeling off and damages. | Considering the above, it is hereby proposed to replace all such door shutters of Production General Pharma (Non-Ceph) floor with Stainless Steel (SS) shutters in order to enhance cleanliness, ensure compliance with | RA-0028-26-P | Approved | 31/01/2027 | In Progress | Pharma | 01) Air flow direction should be verified as per validated pattern. (Engineering)
02) Magnehelic Stability will be verified. (Engineering)
03) Smoke study will be performed. (Engineering)
04) Environmental monitoring will be performed. QC (Micro)
|
| 01) Jan-27
02) Jan-27
03) Jan-27
04) Jan-27
| Muhammad Haris | 05/05/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0062-26 | 05/05/2026 | PD | Permanent | Moderate | Change in Dissolution specification of Xilica CR 82.5mg Tablet. | The current dissolution specification of the above-mentioned product is as follows:
Test: Dissolution (at 1 hour): Specifications: 14-24%
Test: Dissolution (at 4 hour): Specifications: 36-54%
Test: Dissolution (at 9 hour): Specifications: 58-78%
Test: Dissolution (at 24 hour): Specifications: NLT 80% | It is proposed to revise the dissolution profile/ specification of the product as follows:
Test: Dissolution (at 1 hour): Specifications: 12-32%
Test: Dissolution (at 4 hour): Specifications: 40-60%
Test: Dissolution (at 9 hour): Specifications: 60-80%
Test: Dissolution (at 24 hour): Specifications: NLT 80% | RA-0027-26-P | Approved | 31/07/2026 | In Progress | Pharma | 01) Justification will be submitted to QA. (PD)
02) Testing method will be revise. (QC)
03) Finish product specification will be revise in SAP. (QC)
04) Validation protocol will be update. QA(Val)
|
| 01) Done
02) July-26
03) July-26
04) July-26
| Muhammad Haris | 05/05/2026 | Muhammad Haris | 09/07/2026 |
|
| CMP-0063-26 | 13/05/2026 | International Business | Permanent | Moderate | Addition of "Distributed by:" before the distributor's name on all unit cartons in Cambodia. | Only distributor's name is over-printed on the unit cartons. | "Distributed by:" will be added before the name of the distributor. | N/A | Approved | 30/06/2026 | In Progress | Pharma | 01) Trial will be perform for inkjet printer. (BD)
02) "Distributed by" will be print on unit carton. (Production)
| 01) Done
| 01) May-26
02) June-26
| Muhammad Haris | 13/05/2026 | Muhammad Haris | 12/06/2026 |
|
| CMP-0064-26 | 13/05/2026 | Validation | Permanent | Major | Induction of detergent (RBS 705). | Currently, equipments are cleaned using treated water and rinse from hot purified water. | It is proposed to introduce RBS 705 in the cleaning process for production equipment and accessories along with hot water to improve removal of product residues and enhance cleaning effectiveness. | RA-0031-26-P | Approved | 31/12/2026 | In Progress | Pharma |
|
|
| Muhammad Haris | 13/05/2026 | Muhammad Haris | 09/07/2026 |
|
| CMP-0065-26 | 25/05/2026 | SCM | Permanent | Minor | New Vendor induction. | We are purchasing Unit Carton, Direction Insert, Label, Catch Cover, Other secondary packaging materials from different suppliers. | It is proposed to procure Unit Carton, Direction Insert, Label, Catch Cover, Other secondary packaging materials also from new vendor M/s. Teamwork Packages (Pvt) Ltd. Located at 136-137, Korangi industrial area, sector 23, Karachi. | N/A | Approved | 31/08/2026 | In Progress | Pharma | 01) Vendor will be qualify based on onsite audit. (QA)
02) Approved vendor list will be update. (QA)
03) Supplier name will be added in SAP. (SCM)
04) Print proof and shade card will be approve. (QC)
|
| 01) June-26
02) July-26
03) Aug-26
04) Aug-26
| Muhammad Haris | 25/05/2026 | Muhammad Haris | 12/06/2026 |
|
| CMP-0066-26 | 25/05/2026 | SCM | Permanent | Major | Additional source induction of Vildagliptin. | We have approved sources for Vildagliptin as M/s Jiangxi Synergy, Fuxin Long Rui and Ms. Aparna Organics. | We intend to induct one more source M/s. Zhajiang Tianyu Pharmaceutical Co. Ltd No.15, Donghai 5th Avenue, Zhejiang Provincial Chemical and Medical Raw Materials Base Linhai Zone, Taizhou city, Zhejiang Province 317016, China. | N/A | Approved | 28/02/2027 | In Progress | Pharma | 01) Source approval document will be submitted to QA. (SCM)
02) Procurement of material from new source. (SCM)
03) Vendor list will be updated. (QA)
04) Source name will be added in SAP. (QA)
05) Process validation will be perform on three consecutive batches.
06) Stability will be perform on validation batches. (QC)
|
| 01) Aug-26
02) Oct-26
03) Aug-26
04) Aug-26
05) Feb-27
06) Feb-27
| Muhammad Haris | 25/05/2026 | Muhammad Haris | 12/06/2026 |
|
| CMP-0067-26 | 02/06/2026 | Production | Permanent | Moderate | Standardization of yield calculation and reconciliation in batch documents as per SOP No: PMG/2/084, Revision No: 02 | Currently, yield calculations are recorded in batch documents; however, theoretical yield, progressive yield and final packaging yield calculations are not fully aligned and standardized as per the requirements of SOP No: PMG/2/084. | It is proposed to align yield calculation practices in Batch Manufacturing Records (BMRs) and Batch Packaging Records (BPRs) with the requirements of SOP No: PMG/2/084. Theoretical yield and progressive yield shall be calculated, verified, and documented at each applicable stage of manufacturing. Final packaging yield shall be calculated based on total packed quantity, including QA retention/ sample packs and other approved quantities, in accordance with the approved SOP. | N/A | Approved | 31/12/2026 | In Progress | Pharma | 01) Batch documents (BMR and BPR) will be revise. (QA)
02) SOP of "Standardization of yield calculation and reconciliation in batch documents" (PMG/2/084) will be revise. (Production)
03) Training will be provided to concern person. (Production)
|
| 01) Dec-26
02) Aug-26
03) Aug-26
| Muhammad Haris | 02/06/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0068-26 | 02/06/2026 | Engineering | Permanent | Major | Replacement of G-01 door frames (Sol. Prep, Technical Area & Sieving) in General Pharma (Non-Ceph) Production floor. | Currently, door frames installed at the production floor Granulation-01 (Sol Prep Room, Sieving, Technical Room) of General Pharma (Non-Ceph) are in a damaged and rusted condition, which is not compliant with GMP standards. | Considering the above condition, it is hereby proposed to replace door frames at Granulation-01 (Sol Prep Room, Technical Area & Sieving) production area of General Pharma (Non-Ceph) with new MS door frames to ensure compliance with GMP standard. | RA-0028-26-P | Approved | 31/08/2026 | In Progress | Pharma | 01) All door frames of G-01 area will be replace with MS door frames. (Engineering)
02) Environmental monitoring will be perform. QC (Micro)
03) Smoke study will be perform. (Engineering)
|
| 01) Aug-26
02) Aug-26
03) Aug-26
| Muhammad Haris | 02/06/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0069-26 | 04/06/2026 | PD | Permanent | Moderate | Change of coating material in Gouric 80mg and 40mg from in house coating formulation (sheffcoat PVA White 5Y01440, Quinoline Yellow and Lake Brilliant Blue) to ready-made Sheffcoat PVA Green 5Y04077. | Gouric 40mg & 80mg is being coated with Sheffcoat PVA White Quinoline Yellow and Lake Brilliant Blue Color during the coating process to achieve bright green color.
Existing color of Gouric 80mg is light green. | It is proposed to use Ready-made Sheffcoat PVA Green directly in the coating process.
It is proposed to use the same coating material of Gouric 80mg and 40mg. | RA-0032-26-P | Under Approval | | | Pharma | 01) PD trial documents required. (PD)
02) Accelerated and long term stability required of trial batch. (PD)
03) BOM will be revise in SAP. (QA)
04) Batch documents (BDR and BMR) will be revise. (QA)
05) Routing will be create in SAP. (Production)
06) Testing method will be revise. (QC)
07) Finish product specification will be update in SAP. (QC)
08) Process validation will be performed on three consecutive batches at coating stage. QA(Val)
09) Stability study will be perform on validation batches. (QC)
10) After manufacturing of validation batches SAP BOM will be revert to previous formulation. Previous version of batch documents will be effective again till three months stability results of validation batches. After three months stability results further decision will be made. (QA)
11) After testing of validation batches SAP specification for finished product will be revert back to previous specification. Previous version will be effective again till the three month stability result of validation batches. After the three months stability results further decision will be made. (QC)
12) Validation batches will be released after satisfactory three months stability. (QA)
13) Variation will be submitted in DRAP. (RA)
|
|
| Muhammad Haris | 04/06/2026 | Muhammad Haris | 13/07/2026 |
|
| CMP-0070-26 | 05/06/2026 | PD | Permanent | | Change in coating material for Evopride Plus 1/500mg tablet and Evopride 2/500mg tablet to resolve coating related challenge. | Currently, Sheffcoat White (5Y00625) is being used for both strengths of Evopride Plus tablets. During the coating stage, issues such as edge defects and shade variation have been observed in the finished tablets. | It is proposed to replace Sheffcoat White (5Y00625) with Sheffcoat PVA White (5Y01440) to improve the finished product appearance and to resolve the observed issues during the coating stage. | RA-0033-26-P | Under Approval | | | Pharma | 01) PD trial documents required. (PD)
02) Existing inventory of 200kg Sheffcoat White (5Y00625) will be consume. (SCM)
03) BOM will be revise in SAP. (QA)
04) BDR and BMR will be revise. (QA)
05) Routing will be create in SAP. (Production)
06) Testing method will be revise. (QC)
07) Finish product specification will be update in SAP. (QC)
08) Process validation will be perform on three consecutive batches at coating stage. QA(Val)
09) Stability will be perform on validation batches. (QC)
10) Variation will be update in DRAP. (RA)
|
|
| Muhammad Haris | 05/06/2026 | Muhammad Haris | 24/06/2026 |
|
| CMP-0071-26 | 05/06/2026 | Quality Assurance | Permanent | | Induction of New equipment refrigerator BPR-5V628 Bio-Base China in retention room General Pharma. | Currently, no refrigerator available in retention room General Pharma. | Induction of new equipment Refrigerator BPR-5V628 Bio-Base China in retention room General Pharma. | | Approved | | In Progress | Pharma | 01) DQ, IQ and OQ will be perform through vendor. QA(Val)
02) SOP will be prepare. (QA)
03) Training will be provided to concern person. QA(Val)
04) PQ will be perform. QA(Val)
05) Equipment list will be revise. QA(Val)
06) Calibration list will be update. QA(Val)
|
|
| Hamza Ahmed | 05/06/2026 | Muhammad Haris | 03/07/2026 |
|
| CMP-0072-26 | 08/06/2026 | PD | Permanent | Major | New launch product Tofacitinib 5mg tablet. | Product development activities of generic Tofacitinib 5mg tablet has been completed. | It is proposed to commercialize Tofacitinib 5mg tablet in PharmEvo facility. Batch size for Tofacitinib 5mg is 100,000 tablets (15Kg) | RA-0034-26-P | Approved | 31/10/2027 | In Progress | Pharma | 01) Trial documents required. (PD)
02) Stability study documents required. (PD)
03) Containment approach report is required. (PD)
04) Cleanibility report is required. (PD)
05) Technology transfer protocol (for process) is required. (PD)
06) Technology transfer protocol (for analytical) is required. (PD)
07) Registration letter is required. (RA)
08) Source approval documents will be submitted to QA. (SCM)
09) Procurement of Raw material. (SCM)
10) Artwork will be develop and approved. (BD)
11) Item code will be open for new develop artwork. (BD)
12) SFG and FG codes will be open. (SCM)
13) Procurement of packaging material. (SCM)
14) Analytical testing method will be prepare. (QC)
15) BOM will be create in SAP. (QA)
16) Batch documents (BDR, BMR and BPR) will be prepared. (QA)
17) Routing will be create in SAP. (Production)
18) Planning of product launch for commercial. (BD)
19) Process validation will be performed. QA(Val)
20) Hold time study will be perform. QA(Val)
21) Assessment will be perform for cleaning validation. QA(Val)
22) Product will be charge on stability study. (QC)
|
| 01) Done
02) Done
03) Aug-26
04) Aug-26
05) Sep-26
06) July-26
07) Aug-26
08) July-26
09) Oct-26
10) Sep-26
11) Sep-26
12) Aug-26
13) Oct-26
14) Nov-26
15) Dec-26
16) Dec-26
17) Dec-26
18) Dec-26
19) April-27
20) Oct-27
21) Aug-26
22) Aug-25
| Muhammad Haris | 08/06/2026 | Muhammad Haris | 03/07/2026 |
|
| CMP-0073-26 | 08/06/2026 | PD | Permanent | Major | New launch product Mirogablin 2.5mg, 5mg, 10mg and 15mg tablet. | Product development activities of generic Mirogabalin 2.5mg, 5mg, 10mg and 15mg tablet has been completed. | It is proposed to commercialize Mirogabalin 2.5mg, 5mg, 10mg and 15mg tablet in PharmEvo facility.
1) Batch size for Mirogabalin 2.5mg is 150,000 (15Kg)
2) Batch size for Mirogablin 5mg is 150,000 (15Kg)
3) Batch size for Mirogabalin 10mg is 100,000 tablet (20Kg)
4) Batch size for Mirogabalin 15mg is 50,000 tablet (15Kg) | RA-0035-26-P | Approved | 30/11/2027 | In Progress | Pharma | Mirogabalin 2.5mg Tablets, Mirogabalin 5mg Tablets and Mirogabalin 10mg Tablets and Mirogabalin 15mg Tablets:
01) Trial documents required. (PD)
02) Stability study documents required. (PD)
03) Containment approach report is required. (PD)
04) Cleanability approach report is required. (PD)
05) Technology transfer protocol (for process) is required. (PD)
06) Technology transfer protocol (for analytical) is required. (PD)
07) Registration letter is required. (RA)
08) Source approval documents will be submitted to QA. (SCM)
09) Procurement of raw material. (SCM)
10) Artwork will be develop and approved. (BD)
11) Item code will be open for new develop artwork (BD)
12) SFG and FG codes will be open. (SCM)
13) Procurement of packaging material. (SCM)
14) Blister tubes tooling will be procured for Mirogabalin 5mg tablets. (Production)
15) Analytical testing method will be prepare. (QC)
16) BOM will be create in SAP. (QA)
17) Batch documents (BDR, BMR and BPR) will be prepared. (QA)
18) Routing will be create in SAP. (Production)
19) Planning of product launch for commercial. (BD)
20) Process validation will be perform. QA (Val)
21) Hold time study will be perform. QA (Val)
22) Assessment will be perform for cleaning validation. QA (Val)
23) Product will be charge on stability study. (QC)
|
| 01) Done
02) Done
03) Aug-26
04) Aug-26
05) Sep-26
06) July-26
07) July-26
08) July-26
09) Nov-26
10) Aug-26
11) Aug-26
12) July-26
13) Sep-26
14)
15) Oct-26
16) Nov-26
17) Nov-26
18) Nov-26
19) Nov-26
20) May-27
21) Nov-27
22) Aug-26
23) Aug-26
| Muhammad Haris | 08/06/2026 | Muhammad Haris | 03/07/2026 |
|
| CMP-0074-26 | 08/06/2026 | BD | Permanent | Moderate | Revision of address on unit carton of Evopride 2mg in Vietnam. | Currently the following address is mentioned on the unit carton:
270A Lý Thu?ng Ki?t, P14, Q10, TPHCM
| It is proposed to add the following address as per distribution request.
270A Lý Thu?ng Ki?t, Phu?ng Diên H?ng, TP HCM | N/A | Approved | 31/08/2026 | In Progress | Pharma | 01) Artwork will be develop and approve. (BD)
02) Item code will be open. (BD)
03) BOM will be update in SAP. (QA)
04) BPR will be update. (QA)
05) Specification will be update in SAP. (QC)
| 01) Done
02) Done
03) Done
| 01) June-26
02) June-26
03) June-26
04) Aug-26
| Muhammad Haris | 08/06/2026 | Muhammad Haris | 13/07/2026 |
|
| CMP-0075-26 | 08/06/2026 | RA | Permanent | | Change in tablet appearance (color differentiation) for Avsar Tablets 160/5mg and 160/10mg. | Currently, both Avsar 160/5mg and Avsar 160/10mg tablets have the same appearance, i.e., yellow-colored, oblong- shaped, film coated tablets with a bisect line on one side and plain on the other side. This similarity in appearance may lead to difficulty in visual identification of the two strengths. | Differentiate the tablet color of the two strengths as follows:
01) Avsar 160/5mg: Dark Yellow film-coated tablet. 02) Avsar 160/10mg: Light Yellow film-coated tablet. | N/A | Approved | | In Progress | Pharma | 01) PDR to be revised. (PD)
02) Batch documents will be revised. (QA)
03) FP specification will be revised. (QC)
04) LIMS/ SAP will be updated. (QC)
05) Stability protocol will be provided. (QC)
06) Validation protocol will be revised. /Justification letter will be provided. (Validation)
|
| 01) 12/06/2026
02) 12/06/2026
03) 12/06/2026
04) 12/06/2026
05) 12/06/2026
06) 12/06/2026
| Muhammad Haris | 08/06/2026 | Muhammad Haris | 22/06/2026 |
|
| CMP-0076-26 | 09/06/2026 | SCM | Temporary | | Use of U/C Zilero 2.5 mg 30's HM Packaging Material on BM-350 for Consumption of Remaining A/F and D/I Stock | Currently, we have A/F & D/I of Zilero 2.5mg tablet. 30's CP on BM-350 specs in inventory. | It is requested to use 1200004765 U/C Zilero 2.5mg 30s HM on BM-350 to consume remaining stock of A/F and D/I for one batch only. | | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 09/06/2026 | Muhammad Haris | 16/06/2026 |
|
| CMP-0077-26 | 22/06/2026 | BD | Permanent | | Implementation of Pharma Codes as per Hoonga Specifications. | Currently, the artworks used on the Hoonga Blister Machine do not include Pharma Code on the unit carton (U/C) and leaflet. | All existing artworks used on the Hoonga Blister Machine will be revised to include a pharma code on the unit carton (U/C) and leaflet on same item codes. | N/A | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 22/06/2026 | | |
|
| CMP-0078-26 | 24/06/2026 | PD | Permanent | | Induction of "Sheffcoat PVA Green 5Y01077" from manufacturer "Kerry DO BRASIL LTDA". | Currently, Sheffcoat PVA Green 5Y01077 is not part of inventory. | It is proposed to induct and approve Sheffcoat PVA Green 5Y01077 from manufacturer "Kerry DO BRASIL LTDA". Address: ALAMEDA ARAPOEMA, 480-CENTRO EMPRESARINAL DE-TAMBORE-BARUERI-SAOPALO-BRASIL. | N/A | Approved | | In Progress | Pharma | 01) Source approval documents will be submitted to QA. (SCM)
02) Procurement of material from new source. (SCM)
03) New material code will be open. (SCM)
04) Vendor list will be updated. (QA)
05) Source name will be added in SAP. (QA)
06) Process validation will be performed. QA(Val)
07) Stability will be perform on validation batches. (QC)
|
| 01) July-26
02) Oct-26
03) July-26
04) Aug-26
05) Aug-26
06)
07)
| Muhammad Haris | 24/06/2026 | Muhammad Haris | 09/07/2026 |
|
| CMP-0079-26 | 06/07/2026 | BD | Permanent | | Launch of Glyzemlina 10/5mg and Glyzemlina 25/5mg for Exphar in French West Africa. | The products mentioned below are not launched yet.
S.No: 01. Products: Glyzemlina 10/5mg. Generic: Empagliflozin + Linagliptin. Pack Szie: 4x7's. Shelf Life: 24months. Registration Timeline: Registered.
S.No: 02. Products: Glyzemlina 25/5mg. Generic: Empagliflozin + Linagliptin. Pack Szie: 4x7's. Shelf Life: 24months. Registration Timeline: Registered. | These products will be manufactured for Exphar and Exphar will market these products in French West Africa. These products will solely be manufactured for Exphar. | | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 06/07/2026 | | |
|
| CMP-0080-26 | 06/07/2026 | BD | Permanent | | Shifting of Physician Samples of Srilanka to new standard tool on 2DT blister machine. | Physician Samples in Srilanka are being supplied either by cutting or folding the commercial blisters. | New standard tool for Physician Samples have been developed and currently marketed products of Srilanka will be shifted on the new tool. New Aluminium foils will be developed along with Unit Cartons and DI. | | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 06/07/2026 | | |
|
| CMP-0081-26 | 07/07/2026 | Warehouse | Permanent | | Induction of New Logistics Service Provider. | Finished products are currently dispatched through TCS, LCS, M&P, T.M Cargo, Kinetic, Cargoline. | Induction of a new logistics service provider (MTN Transport Network) with temperature- controlled (below 25C) and dry vehicles. | | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 07/07/2026 | | |
|
| CMP-0082-26 | 07/07/2026 | Warehouse | Permanent | | Change the name of Kinetic Logistics to Kinetic Business Solution. | Kinetic logistics transportation invoices & CN were previously issued under Kinetic Logistics accounts. | Effective immediately, all FTL (Full Truck Load) operations will be processed exclusively through the Kinetic Logistics account. All invoices & CN for FTL services will be issued in the name of Kinetic Business Solutions. | | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 07/07/2026 | | |
|
| CMP-0083-26 | 14/07/2026 | BD | Permanent | | Launch of S-GLP (Semaglutide) injections in local market through contract manufacturing. | S-GLP (Semaglutide) injections are not launched in the local market yet:
Brand Name: S-GLP 0.25mg/0.188ml. Generic Name: Semaglutide. Dosage Form: Injection. Strength: 0.25mg/0.188ml. Pack Size (CP): 1's. Name of Contract Manufacturer: Ferozsons Laboratories Limited.
Brand Name: S-GLP 0.5mg/0.375ml. Generic Name: Semaglutide. Dosage Form: Injection. Strength: 0.5mg/0.375ml. Pack Size (CP): 1's. Name of Contract Manufacturer: Ferozsons Laboratories Limited.
Brand Name: S-GLP 1mg/0.75ml. Generic Name: Semaglutide. Dosage Form: Injection. Strength: 1mg/0.75ml. Pack Size (CP): 1's. Name of Contract Manufacturer: Ferozsons Laboratories Limited. | S-GLP (Semaglutide) injections are planned for launch in the local market through Contract Manufacturing. | | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 14/07/2026 | | |
|
| CMP-0084-26 | 14/07/2026 | QC | Permanent | | Addition of Disintegration Test in Finished Product Specification | Currently, Disintegration Test is performed in IPC at core stage but it is not part of finished product testing method. | It is proposed to include the disintegration test in the finished product specifications. The test will not be a part of the finished product release specification; however, it will be performed on every manufactured batch and the results will be documented in the corresponding raw data records. | | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 14/07/2026 | | |
|
| CMP-0085-26 | 14/07/2026 | RA | Permanent | | Update the existing artwork of Arbi-H 150/12.5mg, 300/12.5mg and 300/25mg tablets in Srilanka. | The generic name on existing artwork of Arbi-H 150/12.5mg, 300/12.5mg and 300/25mg tablets in Srilanka is not aligned as per the guideline on labelling of medicine dated (15/10/2019) by NMRA. | The Generic Name of the artworks for Arbi-H 150/12.5mg, 300/12.5mg and 300/25mg tablets will be updated to meet the labelling requirements as per guideline on labelling of medicine dated (15/10/2019) issued by National Medicine Regulatory (NMRA), Srilanka | | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 14/07/2026 | | |
|
| CMP-0086-26 | 16/07/2026 | BD | Permanent | | Change in Direction Insert of Erli Plus XR Tab 12.5/1000mg 4X7's already launched in Iraq. FG Code: 1400000629 | The current DI for Erli Plus XR Tab. 12.5/1000mg 4X7's Iraq (Item Code: 1200002537) contains prescribing information for only a single strength. | Replace the exisiting DI with a new harmonized DI (Item Code:12000003894) that includes prescribing information for all strengths of Erli Plus XR tablets. | N/A | Under Approval | | | Pharma |
|
|
| Muhammad Haris | 16/07/2026 | | |