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

Biocon Receives GMP approval for Biologics Drug Substance facilities from French Regulator; Drug Product facility to be re-inspected

Bengaluru, Karnataka, India, July 09, 2017:

“The French inspecting authority (ANSM) conducted pre-approval inspection audits of our Bangalore drug substance and drug product sites related to the pending EMA Marketing Authorization Applications for Trastuzumab, Pegfilgrastim, and related to Insulin Glargine (pen assembly only).

While there were no critical observations mentioned in the final report, ANSM notified Biocon that the receipt of a GMP compliance certificate for the drug product facility will require a follow up inspection from ANSM to verify implementation of the proposed  corrective and preventive actions (CAPAs). ANSM has reviewed the proposed CAPA plan and Biocon is progressing towards completion of the implementation of these CAPAs. Biocon, with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow-up inspection of the drug product facility and the Marketing Authorization Applications with the goal of an early re-inspection.

We are pleased however that ANSM has issued GMP compliance certificates for our two drug substance manufacturing facilities in Bangalore. This is important as the drug substance manufacture is core to the production of the actual biologic product in GMP compliance.

Biocon is committed to ensuring the highest level of quality in all of its products.”

- Company Spokesperson

Video Credits: CNBC-TV18

<< Back


 Download 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