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Biocon Receives EIR from US FDA for Visakhapatnam API Facility Following Successful Inspection

  • Fri, 30-Aug-2024
  • Posted by: BIOCON
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NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

 

Visakhapatnam, Andhra Pradesh, India, August 30, 2024

“This is to inform you that the Company has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (US FDA), for our greenfield API facility (Site 6), located at Visakhapatnam, Andhra Pradesh.

This is based on a pre-approval inspection conducted by the agency between the 10th and 14th of June, 2024, and now allows us to commence commercial supplies from this facility to the U.S. market.”


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Author: BIOCON

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