SHILPAMEDNSEShilpa Medicare Limited· PharmaceuticalsHighPositive
Announced Sat, 3 May · 14:49 IST

Shilpa Medicare Limited has informed the Exchange about Europe (AGES, Austria) Inspection of Shilpa Biologicals Pvt Ltd (SBPL), a wholly owned subsidiary ofShilpa Medicare Ltd.

Regulatory Product ApprovalBusiness Updates View source PDF

SHILPAMED · price

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▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.

Price reaction · full curve

Awaiting price reaction for this filing.

AI summary

Shilpa Medicare's biologics arm, Shilpa Biologicals Pvt Ltd (SBPL), has received European GMP certification for its manufacturing site in Dharwad, Karnataka. The certification followed an inspection conducted by Austria's regulatory authority (AGES) from February 18 to 20, 2025. The inspection covered the sterile drug product filling and packaging line, quality systems, and quality control laboratories, and the facility was found compliant with EU GMP guidelines under Directive (EU) 2017/1572. Shilpa Biologics' CEO, Dr. Sridevi Khambhampaty, said the outcome affirms the company's commitment to global quality standards. This enables the Dharwad facility to manufacture test batches for European markets.

Likely market impact

Positive for shareholders — EU GMP certification opens the door to manufacturing and supplying biologics to European clients, which could translate into new contract development and manufacturing orders and revenue growth from the biologics segment.