CONTACT
+91 80 2808 2808
info@biocon.com

Biocon Biologics’ Drug Substance Facility in Bengaluru Classified as Voluntary Action Indicated (VAI)

  • Posted by: BIOCON

NOTIFICATION TO STOCK EXCHANGE

COMPANY STATEMENT

Bengaluru, Karnataka, India, Oct 30, 2024

“The U.S. Food and Drug Administration (FDA) has classified Biocon Biologics’ Drug Substance Facility at Biocon Campus, (Site 1) located in Bengaluru, Karnataka, as Voluntary Action Indicated (VAI).

This relates to the cGMP inspection conducted by the agency between February 20-28, 2024 and pertains to the supply of rh-Insulin (rhI) Drug Substance to the United States.

Biocon Biologics remains committed to global standards of Quality and Compliance.”

– Company Spokesperson

Author: BIOCON
Share
Leaving the Biocon site!

You are now leaving the Biocon website for a Biocon affiliate site or third party site that is solely responsible for its content, including its compliance with guidelines applicable in certain geographies. Links to Biocon affiliate sites and third party sites are provided as a resource to our visitors and may not be governed by the same regulatory requirements applicable to this site and unaffiliated third party sites are subject to their own terms and data protection notices and practices. Moreover, if their third party site is subject to other country laws, regulatory requirements, data protection requirements or medical practices may differ between countries and the information provided therein may not be suitable for use in your country.

Agree >>