News about Quality / GMP

Concord Biotech Limited receives EIR for Unit III

Concord Biotech Limited receives EIR for Unit III

Quality / GMP | 23/08/2023 | By Sudeep Soparkar |  1506

Successful FDA inspection at Auriscos manufacturing site in Yangzhou, China

Successful FDA inspection at Aurisco's manufacturing site in Yangzhou, China

Quality / GMP | 16/08/2023 | By Sudeep Soparkar |  886

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 |  969

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 |  1909

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 |  798

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 |  1256

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 |  1453

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 |  1121

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 |  645

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 |  783