EU-GMP Certification Renewed for Unit II Facility

Regulatory Product ApprovalBusiness Updates View source PDF

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AI summary

OneSource Specialty Pharma has received the renewal of its European Union Good Manufacturing Practices (EU-GMP) certification for its flagship Unit II manufacturing facility in Bengaluru. The certification was granted after an inspection by a European regulatory authority. Unit II is an integrated biologics drug-substance and drug-product manufacturing site with capabilities in drug-device combinations and sterile injectable products. The renewal allows the company to continue manufacturing and supplying products for the European market.

Likely market impact

Positive — EU-GMP renewal enables continued manufacturing and exports to European markets, supporting existing and new business opportunities.