About Biocon Biocon's Products & Services Research & Development Biocon's Technology Investors Media Careers CSR

Company Statement

Pre -Approval U.S. FDA Inspection Conducted at Biocon’s Insulins Facilities in Malaysia

Bengaluru, India, July 8, 2019

"This is to inform you that Biocon Sdn Bhd’s Insulin Glargine Drug Substance, Drug Product and Device assembly facilities in Malaysia underwent a pre-approval inspection by the U.S. FDA between June 24 and July 5, 2019. The inspection across these 3 units concluded with 12 observations issued on the Form 483.

We will respond to the FDA with a Corrective and Preventive Action Plan and are confident of addressing these observations expeditiously. We do not expect any change to our commercialization plans for Insulin glargine in the U.S. Biocon remains committed to global standards of Quality and Compliance."

- Company Spokesperson

<< Back


Download the notification


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