Biocon Malaysia Gets EMA Approval to Supply Semglee Insulin to Europe
Bengaluru: Biocon Limited has announced that Biocon Malaysia has received approval from the European Medicines Agency (EMA) for a new drug product fill finish line for Semglee (insulin glargine) at its insulin manufacturing facility in Malaysia.
The company disclosed the development through a regulatory filing with the stock exchanges on July 16, 2026, under applicable SEBI regulations.
According to the company, the EMA approval covers the newly established fill finish line for Semglee (insulin glargine), enabling Biocon Malaysia to manufacture and supply the insulin product from the approved facility for the European market. The approval marks a significant regulatory milestone for the company's insulin manufacturing operations in Malaysia.
Biocon stated that commercial supplies to Europe from the newly approved fill finish line are expected to commence from the second quarter of FY2026-27 (Q2FY27). The company indicated that the approval supports its plans to strengthen the supply of insulin products to European markets through its Malaysian manufacturing facility.
The company issued the announcement in the form of a Company Statement titled "Biocon Malaysia Receives EMA Approval for New Drug Product Fill Finish Unit for Insulins", which was enclosed with its stock exchange filing. Biocon also informed investors that the information would be made available on its official website.
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