Granules Pharmaceuticals successfully completes USFDA post marketing adverse drug experience inspection with zero observations

The inspection was conducted at Granules Pharmaceuticals Inc. (GPI) from July 31, 2023 to August 03, 2023

USFDA completes two cGMP inspections at Biocon Biologics' insulins facility in Malaysia

The agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories

USFDA completes inspection at Dr Reddy's Laboratories' Bollaram API unit

The inspection closed with zero observations

Bliss GVS Pharma updates on inspection by USFDA

The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection

Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection

This is the second US FDA GMP inspection of this facility within one year

Lupin announces completion of pharmacovigilance inspection by USFDA

The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide

Lupin announces successful completion of UK MHRA inspection of Pithampur facilities

With the combination of oral solid, inhalation, dermatology, high potent and oral contraceptive products, this is an important facility of the company

USFDA completes inspection of Lupin’s Vizag facility

The inspection concluded with no observations

Strides flagship facility in Bangalore receives USFDA inspection closure

USFDA completes regulatory inspection of Natco's Vizag formulation facility

At the end of the inspection, the facility received two observations, one on written production process control procedure and the other on investigation procedure