11-Sept-2026 13:26:45

SHILPA MEDICARE: SEC GRANTS MARKETING AUTHORIZATION FOR OERISTM

• Shilpa Medicare Limited has received final approval from the Subject Expert Committee (SEC) under CDSCO for marketing authorization of OERIS™ (Ondansetron Extended-Release Injection, 100 mg/mL). • OERIS™ is designed to be the world's first extended-release ondansetron injectable formulation providing sustained antiemetic action for up to 120 hours (5 days) following a single administration. • The approval is based on successful completion of a multicenter, randomized, double-blind Phase III trial. • OERIS™ will be launched in India and enjoys patent protection until 2039. • The company plans to initiate commercial launch across India upon receipt of final marketing authorization.

Shilpa Medicare Limited

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