The approval expands Biocon’s capacities, with new large scale devices facility coming up to speed to serve growing needs of people with diabetes in EU
Biocon a biopharmaceuticals company, announced that it’s subsidiary in Malaysia, Biocon Sdn Bhd, which operates Asia’s integrated insulins facility, received the Certificate of GMP compliance from the European Medicines Agency from the representative European inspection authority, Health Products Regulatory Authority (Ireland). This approval expands Biocon’s capacities multi-fold with the new large scale devices facility coming up to speed to serve the growing needs of people with diabetes in EU.
The Malaysia site was inspected in May 2019 and the certificate of GMP compliance received now reflects that the agency considers the manufacturing facilities for drug substances, drug products and insulin delivery devices to be in compliance with the guidelines of Good Manufacturing Practices. Biocon remains committed to highest global standards of quality and compliance.
The recombinant human insulin (rh-Insulin) and Insulin glargine manufactured at this facility are addressing the needs of over 350,000 diabetic patients in Malaysia. Biocon and Mylan’s Biosimilar Insulin Glargine Semglee has previously received regulatory approval from EMA in March 2018 and has been launched in key European markets by its partner Mylan since Nov 2018.