News about Quality / GMP

Dr. Reddys API plant in Hyderabad gets EIR from U.S. FDA

Dr. Reddy’s API plant in Hyderabad gets EIR from U.S. FDA

Quality / GMP | 08/08/2023 | By Sudeep Soparkar |  1675

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 |  721

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 |  1107

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 |  1303

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 |  994

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 |  601

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 |  708

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 |  3881

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 |  670

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 |  2625