Biocon Biologics receives 5 procedural observations after US FDA inspection at Bengaluru facility
The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026
The US FDA completed a pre-license inspection of Biocon Biologics’ biosimilars manufacturing site at Biocon Park between April 20 and April 29, 2026
The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026
The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets
Patalganga plant received zero observation from USFDA earlier
The company stated that it will work closely with the regulator to address the observations within the stipulated timeframe
The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices
Granules Consumer Health serves as Granules’ front-end division for OTC products in the US
The said inspection concluded with Zero Form 483 observation
The inspection concluded with NIL observations
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