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Shilpa Medicare gets SEC’s final approval for OERIS
Sep-11-2026

Shilpa Medicare has received final approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) for grant of marketing authorization for 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 - a first-of-its-kind approval in both India and globally. OERIS will be launched in India and enjoys patent protection in India until 2039.

SEC’s approval on granting the marketing authorization is based on the successful completion of a multicenter, randomized, double-blind Phase III trial evaluating the safety and efficacy of Shilpa's OERIS for the prophylaxis and control of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately-to-highly emetogenic chemotherapy. By reducing repeat injections to a single dose administered once every five days, the innovative formulation significantly enhances patient convenience and optimizes healthcare staff efficiency. Upon receipt of final marketing authorization from the CDSCO, it plans to initiate commercial launch across India.

Shilpa Medicare produces and exports consistently high-quality Active Pharmaceutical Ingredients Fine Chemicals, intermediates, herbal products and speciality chemical products using sophisticated technology, meticulously following international specifications.


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