News about Quality / GMP

Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis

Viatris and Mapi Pharma Announce FDA Acceptance of New Drug Application Filing for GA Depot for the Treatment of Relapsing Forms of Multiple Sclerosis

Quality / GMP | 08/08/2023 | By Sudeep Soparkar |  588

USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

USFDA concludes inspection at Solara's Cuddalore facility with Zero 483 inspectional observations

Quality / GMP | 08/08/2023 | By Sudeep Soparkar |  593

US FDA issues warning letter to Intas Pharma's Sanand plant

US FDA issues warning letter to Intas Pharma's Sanand plant

Quality / GMP | 07/08/2023 | By Sudeep Soparkar |  909

Granules Pharmaceuticals, Inc. Successfully Completes USFDA Post-Marketing Adverse Drug Experience (PADE) Inspection with Zero Observations

Zero Observations indicate a commitment to the highest level of patient safety and product quality

Quality / GMP | 04/08/2023 | By Sudeep Soparkar |  732

Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of TydemyTM

Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of 2 Lots of TydemyTM

Quality / GMP | 31/07/2023 | By Sudeep Soparkar |  488

Biocon gets 8 observations from USFDA after inspection of Malaysia insulins facility

Biocon gets 8 observations from USFDA after inspection of Malaysia insulins facility

Quality / GMP | 25/07/2023 | By Sudeep Soparkar |  487

Aurobindo Pharma Ltd gets 3 observations from USFDA for Unit 3 at Bachupally Village

Aurobindo Pharma Ltd gets 3 observations from USFDA for Unit 3 at Bachupally Village

Quality / GMP | 24/07/2023 | By Sudeep Soparkar |  2775

Lupin receives tentative approval from U.S. FDA for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets

Lupin receives tentative approval from U.S. FDA for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets

Quality / GMP | 24/07/2023 | By Sudeep Soparkar |  528

Dr. Reddy's Laboratories Limited's API facility at Srikakulam completes USFDA inspection successfully

Dr. Reddy's Laboratories Limited's API facility at Srikakulam completes USFDA inspection successfully

Quality / GMP | 20/07/2023 | By Sudeep Soparkar |  2305

US FDA Inspection at Aurobindo Pharma Ltd's Unit XIV, Anakapalli District, Andhra Pradesh

US FDA Inspection at Aurobindo Pharma Ltd's Unit XIV, Anakapalli District, Andhra Pradesh

Quality / GMP | 18/07/2023 | By Sudeep Soparkar |  457