ONESOURCENSEOnesource Specialty Pharma LimitedHighPositive
Announced Tue, 28 Apr · 21:21 IST

Onesource Specialty Pharma Limited has informed the Exchange about General Updates

Regulatory Product ApprovalBusiness Updates View source PDF

ONESOURCE · price

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AI summary

OneSource Specialty Pharma's Sterile Product Division (SPD) facility in Bangalore has received an EU GMP Certificate of Compliance from a German state authority, dated April 27, 2026, following an inspection on October 14, 2025. The certification covers sterile products including aseptically prepared small volume liquids, secondary packing, and quality control testing. The facility already holds approvals from US-FDA, Health Canada, ANVISA, and TGA, and has capabilities across liquid vials, lyophilised vials, pre-filled syringes, and autoinjectors. This adds the EU regulatory market to the company's list of approved jurisdictions for its sterile manufacturing operations.

Likely market impact

This is a positive development for shareholders, as EU GMP certification opens up commercial supply opportunities into European markets, potentially expanding the customer base and revenue pipeline for the company's contract development and manufacturing business.