+91 80 2808 2808

Biocon Biologics Drug Substance Facilities in Bengaluru Receive EU GMP Certification

  • Posted by: BIOCON


Company Statement

Bengaluru, Karnataka, India – May 12, 2020

“This is to inform you that Biocon Biologics India Ltd., a subsidiary of Biocon Ltd. has received the Certificate of GMP compliance from EMA represented by the competent authority of Germany for its Biologics Drug Substance (DS), facilities at 20th KM, Hosur Road, Bengaluru.

These facilities are used for the manufacture of drug substance of Pegfilgrastim and Recombinant Human Insulin and manufacturing related activities for Insulin Glargine and Insulin Aspart and were inspected by the regulatory agency between January 20 and 23, 2020.

This certification will enable us to continue addressing the growing needs of patients in the EU markets and enhance access to our high quality biosimilars. We remain 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 >>