News about Quality / GMP

Lupins Mandideep Unit-2 Facility Completes U.S. FDA Inspection with No Observations

Lupin’s Mandideep Unit-2 Facility Completes U.S. FDA Inspection with No Observations

Quality / GMP | 14/08/2023 | By Sudeep Soparkar |  922

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 |  1739

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 |  749

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 |  1145

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 |  1352

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 |  1026

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 |  610

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 |  723

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 |  3975

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 |  694