Biocon is deeply committed and invested in addressing patients’ needs for insulins in Malaysia and other parts of the world. To serve the global demand for insulins, Biocon has created a Center of Excellence (CoE) for insulins in Malaysia with end-to-end capabilities for manufacturing its robust portfolio of human insulin and insulin analogs. The state-of-the-art integrated insulin manufacturing facility in Malaysia was set up at an investment of over USD 350 million, representing the largest foreign direct investment (FDI) in Malaysia’s biotechnology sector. Commercial operations at the facility commenced in 2016 when Biocon’s recombinant human insulin became the first locally manufactured biosimilar product approved for sale in Malaysia. A second-phase expansion of USD 250 million to double capacity has further strengthened Malaysia’s position as a global center of excellence for affordable insulins.

Quality Excellence

The Company takes pride in developing world-class insulin products using its proprietary technology platform. Its manufacturing facility in Johor is approved by NPRA, Malaysia as well as several international regulatory agencies like the U.S. FDA, EMA, TGA (Australia), ANVISA (Brazil), and COFEPRIS (Mexico). The facility has state-of-the-art R&D, Quality Assurance, Quality Control labs and a very robust Quality Management System to ensure that every patient, no matter where they live, receive medicines of the highest quality.

The 562,000 sq. ft. facility had been recognized as the first and largest integrated insulin manufacturers in Malaysia by the prestigious Malaysia Book of Records, the official record-keeping body in Malaysia.