Biocon Malaysia Gets UK MHRA Approval for Semglee Insulin Fill-Finish Unit
Bengaluru: Biocon Malaysia has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA), UK, for its new drug product fill-finish unit for Semglee (insulin glargine) at the company's insulin manufacturing facility in Malaysia.
The newly approved facility is intended for the drug product fill-finish operations of Semglee® (insulin glargine) at Biocon’s insulin manufacturing facility in Malaysia.
The latest regulatory clearance follows an earlier approval received by Biocon for the same new drug product fill-finish line. In July 2026, Biocon had secured regulatory approval from the European Medicines Agency (EMA) for the new fill-finish line. The MHRA approval represents an additional regulatory approval for the facility.
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