+91 80 2808 2808

Biocon Biologics Receives EIR from U.S. FDA for Two Manufacturing Facilities, Inspection Stands Closed

  • Posted by: BIOCON


Company Statement

Bengaluru, Karnataka, India – April 16, 2020

“This is to inform you that Biocon Biologics India Ltd., a subsidiary of Biocon Ltd. (BSE code: 532523, NSE: BIOCON), has received the Establishment Inspection Report (EIR) from the U.S. FDA for the Pre-Approval Inspection (PAI) at two of its biologics manufacturing facilities in Bengaluru. The inspection was conducted between September 10 and September 19, 2019. Biocon Biologics has responded to the regulator on the eight observations from this inspection, in the month of October 2019.

Subsequent to the above inspection, Biocon Biologics has received approvals for the two products Trastuzumab (Drug Product) and Pegfilgrastim (Drug Substance) from the U.S. FDA in 2019. The receipt of the Establishment Inspection Report (EIR) indicates a successful closure of the inspection. This is an endorsement of our commitment to global standards of Quality and Compliance.

The formal closure of the U.S. FDA inspection is expected to enable filing of marketing authorization applications for our biosimilar products in several global markets. We stay committed to enable affordable access to our high quality biosimilars for millions of patients across the globe.”

– 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 >>