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

Company Statement on Status of EMA Dossiers

Bengaluru, Karnataka, India, August 16, 2017:

As previously communicated, whilst our drug substance facilities for Trastuzumab and Pegfilgrastim were approved, the European regulatory authorities had informed us of the need for a re-inspection of our drug product facility for these products.

The request for withdrawal of the dossiers and re-submission is part of the EMA procedural requirements linked to this re-inspection and will be considered by the EMA´s Committee for Medicinal Products for Human Use (CHMP).

We are on track to complete our corrective and preventive actions (CAPAs) by the end of this quarter and it is our intent to seek re-inspection and re-submission thereafter.


- 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