The U.S. Food and Drug Administration (US FDA) conducted a GMP surveillance inspection of Biocon’s API facility (Site 6), located at Visakhapatnam, Andhra Pradesh, between November 3rd and 7th, 2025. Two observations were noted at the end of the inspection, which the Company will address within the stipulated time. The Company does not foresee any impact on the business.
GMP Inspection at Visakhapatnam Facility
Biocon has announced that the U.S. Food and Drug Administration (US FDA) completed a Good Manufacturing Practice (GMP) surveillance inspection at its API facility (Site 6) in Visakhapatnam, Andhra Pradesh. The inspection took place between November 3rd and 7th, 2025.
Observations and Company Response
At the conclusion of the inspection, two observations were cited. Biocon has committed to addressing these observations within the stipulated timeframe. The company currently anticipates that these observations will not have any significant impact on its business operations.
Source: BSE
