CONTACT
+91 80 2808 2808
info@biocon.com

Biocon Receives GMP approval for Biologics Drug Substance facilities from French Regulator; Drug Product facility to be re-inspected

  • Posted by: BIOCON

Bengaluru, Karnataka, India, July 09, 2017:

“The French inspecting authority (ANSM) conducted pre-approval inspection audits of our Bangalore drug substance and drug product sites related to the pending EMA Marketing Authorization Applications for Trastuzumab, Pegfilgrastim, and related to Insulin Glargine (pen assembly only).

While there were no critical observations mentioned in the final report, ANSM notified Biocon that the receipt of a GMP compliance certificate for the drug product facility will require a follow up inspection from ANSM to verify implementation of the proposed  corrective and preventive actions (CAPAs). ANSM has reviewed the proposed CAPA plan and Biocon is progressing towards completion of the implementation of these CAPAs. Biocon, with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow-up inspection of the drug product facility and the Marketing Authorization Applications with the goal of an early re-inspection.

We are pleased however that ANSM has issued GMP compliance certificates for our two drug substance manufacturing facilities in Bangalore. This is important as the drug substance manufacture is core to the production of the actual biologic product in GMP compliance.

Biocon is committed to ensuring the highest level of quality in all of its products.”

– Company Spokesperson

Author: BIOCON
Share
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 >>