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
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
Routine regulatory filing confirms completion of demat and share transfer compliances for March quarter
The company will address the observations and respond to the U.S. FDA within the stipulated timeframe
The inspection concluded with zero observations, confirming the facility's compliance with current Good Manufacturing Practices
The Pre-Approval Inspection (PAI) was completed on February 13, 2026, and the company is initiating corrective actions.
These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products
The company will respond to the US FDA within the stipulated timelines
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