About Biocon Our Business Research & Development Biocon's Technology Investors Media Careers CSR
  Press Releases
  Download Center
  Video Gallery
  Photo Gallery
  Media Contacts

Company Statement

Biocon Receives EIR for Small Molecules API Manufacturing Facility for Pre -Approval and GMP U.S. FDA Inspection

Bengaluru, Karnataka, India, May 8, 2020

"This is to inform you that Biocon has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the Pre-Approval and GMP inspection of its Small Molecules API Manufacturing Facility at Biocon Park SEZ, Bommansandra, Bengaluru, conducted between January 20 and January 24, 2020. At the conclusion of the inspection the agency had issued a Form 483, with five observations, which are being addressed by the Company. The EIR has been closed with a "VAI" classification for the observations.

We remain committed to global standards of Quality and Compliance."

- Company Spokesperson

<< Back


Download the
Company Statement


Recommended sites Biocon on  
About Us

Investor Relations
Media Relations
Site Map
Contact Us
Our Growth Accelerators
Fact Sheet
Branded Formulations
Research Services
Active Discovery Program

Karnataka Vision Group on BT
Syngene International
Biocon Academy

    Linked In   
  Report adverse event/side effects and product complaints    
  * Disclaimer            © 2018, Biocon. All Rights Reserved