Bengaluru : Leading Indian biopharmaceuticals company Biocon Ltd has announced today that it’s subsidiary in Malaysia, Biocon Sdn. Bhd., which operates Asia’s largest 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.
Biocon’s Malaysia facility is Asia’s largest integrated insulins facility and manufactures Drug Substance and Drug Products in vials, cartridges and insulin delivery devices.