Biocon Receives Europe GMP Approval For Insulin Facility In Malaysia
Bangaluru-based drugmaker Biocon’s subsidiary in Malaysia, Biocon Sdn Bhd, has been issued a certificate of “GMP Compliance” for its insulin manufacturing facility by the HPRA (Ireland) as the representative European Union inspection authority.
The facility was inspected by Irish drug regulator HPRA as the representative European inspection authority in April 2017.
This is the first overseas biopharma manufacturing and research facility of the firm. It is one of Asia’s largest state-of-the-art integrated insulins manufacturing facilities set up with an investment of about $275 million at the BioXcell Biotech park in Malaysia.
The certificate of GMP compliance reflects that the agency considered the site to be in compliance with the principles and guidelines of Good Manufacturing Practices for active substances, sterile drug products and quality control testing operations.
Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said: “We are pleased to support the Ministry of Health of Malaysia in providing high quality, affordable, rh-insulin for people with diabetes in Malaysia. It is a matter of pride that this is a ‘Made in Malaysia’ insulin product manufactured by Biocon Sdn. Bhd. at the BioXcell Biotech Park in Nusajaya, Johor. We expect our Malaysian facility
to cater to the growing needs for affordable insulins across the globe.”Biocon is one of the first Indian companies to join hands with the Malaysian Government to generate value for Biocon and the Malaysian biotechnology sector. The facility draws a majority of its over 500-strong workforce from the local talent pool. It thus provides Malaysia’s biotechnology graduates and scientists a unique opportunity to make a critical contribution to global healthcare. The commercialization of Biocon’s facility will contribute towards Malaysia’s emergence as a global biotechnology hub.
