
Business Update25 Sept 2026, 08:34 am
Biocon Malaysia gets MHRA approval for insulin fill finish unit
AI Summary
Biocon Limited announced that its Malaysian subsidiary has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its new drug product fill finish unit for Semglee® (insulin glargine). This follows a similar approval from the European Medicines Agency (EMA) in July. The facility is located at Biocon's insulin manufacturing site in Malaysia. This development is significant for Biocon's biosimilar insulin production and market expansion in regulated markets.
Key Highlights
- MHRA approval received for new drug product fill finish unit.
- Unit is for Semglee® (insulin glargine) at Malaysia facility.
- EMA approval for the same line was secured in July.
- Enhances Biocon's biosimilar insulin manufacturing capabilities.
Price Impact
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