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Results For "GMP-inspection"

64 News Found

Strides completes EU GMP inspection at Puducherry facility
News | June 29, 2021

Strides completes EU GMP inspection at Puducherry facility

The company has now received the renewed GMP (Good Manufacturing Practices) certificate thereby confirming the successful closure of the inspection


Briefs: Alembic Pharmaceuticals and Tyche Industries
Drug Approval | September 14, 2025

Briefs: Alembic Pharmaceuticals and Tyche Industries

Alembic receives EIR from USFDA for facility at Panelav


FDA completes inspection at Biocon Biologics' facility in Bengaluru
News | September 05, 2025

FDA completes inspection at Biocon Biologics' facility in Bengaluru

The U.S. FDA issued a Form 483 with five observations


Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations
Drug Approval | August 16, 2025

Zydus’ SEZ II, Ahmedabad plant clears USFDA inspection with nil observations

The inspection concluded with NIL observations


Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
Drug Approval | July 17, 2025

Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru

This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms


Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA
Drug Approval | July 11, 2025

Shilpa Medicare Unit VI facility at Dabaspet receives GMP certification from SFDA

This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product


Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA
Drug Approval | July 06, 2025

Shilpa Pharma Lifesciences Unit-1 inspected by ANVISA

The audit has been concluded with no major observations


Briefs: Dr. Reddy's Laboratories, Relonchem,  Shilpa Pharma Lifesciences and Shanmuga Hospital
News | May 18, 2025

Briefs: Dr. Reddy's Laboratories, Relonchem, Shilpa Pharma Lifesciences and Shanmuga Hospital

Shilpa Pharma Lifesciences, Unit-1, received EIR from USFDA