USFDA conducts PAI and GMP inspection of Piramal Pharma's Sellersville facility

The company remains committed to maintain the highest standards of compliance and will work closely with the agency to comprehensively address all the observations

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

Camurus’ Oclaiz NDA resubmission accepted by FDA

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 10, 2026

Briefs: APL Healthcare, Biocon, USFDA, Sun Pharma and Clean Fino-Chem

USFDA determines Sun Pharma's Baska facility inspection classification as OAI

Ind-Swift Laboratories receives GMP compliance certificate from NNGYK-Hungary

The said certificate is valid for a period of 3 years and opens up the European and other markets for the company's products

Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US

Briefs: Zydus, Divi's Laboratories and Relonchem

FDA closes inspection at Zydus' oncology injectable manufacturing facility in SEZ1, Ahmedabad with 2 observations

Marksans Pharma's Goa unit clears FDA inspection

The said inspection concluded with Zero Form 483 observation

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

Briefs: Alembic Pharmaceuticals and Tyche Industries

Alembic receives EIR from USFDA for facility at Panelav