+91 80 2808 2808

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

  • Posted by: BIOCON


Company Statement

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

Author: BIOCON
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 >>