Biocon Malaysia Gets MHRA Insulin Unit Approval

Date: September 25, 2026

Regulatory Approval Disclosure

Biocon Limited announced that its Malaysian subsidiary has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA), UK for a new drug product fill finish unit dedicated to insulin production.

The approval specifically covers the manufacturing of Semglee® (insulin glargine) at Biocon's insulin manufacturing facility located in Malaysia.

This MHRA approval follows a previous regulatory clearance obtained from the European Medicines Agency (EMA) in July 2026 for the same new drug product fill-finish line.