Biocon Receives EMA Approval for New Insulin Drug Product Fill Finish Unit in Malaysia
Biocon Ltd has received approval from the European Medicines Agency (EMA) to establish a new drug product fill finish line for Semglee® (insulin glargine). The manufacturing unit is situated at the company's insulin production facility located in Malaysia.This development enhances the company's manufacturing capabilities for its insulin products. Biocon expects that commercial supplies to Europe from this dedicated production line will begin during the second quarter of fiscal year 2027 (Q2FY27).DetailInformationProduct InvolvedSemglee® (insulin glargine)Regulatory AuthorityEuropean Medicines Agency (EMA)Manufacturing LocationMalaysia...