Shilpa Medicare Share Price Gains Over 2%; Receives Final SEC Approval for Grant of Marketing Authorisation for OERIS

Shilpa Medicare Ltd has received final approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) for the grant of marketing authorisation for OERIS™, an Ondansetron Extended-Release Injection, as per an exchnage filing dated September 11, 2026. The injection has a strength of 100 mg/mL. 

Five-Day Coverage 

OERIS™ is an extended-release injectable formulation of ondansetron. Shilpa Medicare said the injection is designed to provide antiemetic action for up to 120 hours, or five days, after a single administration. 

The company has described OERIS™ as the world’s first extended-release ondansetron injectable formulation. It is intended for use in the prophylaxis and control of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately-to-highly emetogenic chemotherapy. 

Phase III Trial 

The SEC approval followed the completion of a multicentre, randomised, double-blind Phase III trial. The study examined the safety and efficacy of OERIS™ in patients receiving moderately-to-highly emetogenic chemotherapy. 

The company said the formulation allows repeat injections to be reduced to a single dose administered once every five days. It stated that this can reduce the frequency of injections for patients and the related workload for healthcare staff. 

India Launch 

OERIS™ is planned for launch in India and has patent protection in the country until 2039. Shilpa Medicare said it plans to begin the commercial launch across India after receiving the final marketing authorisation from CDSCO. 

Shilpa Medicare Overview 

Shilpa Medicare is a pharmaceutical company and integrated CDMO working across small molecules, biologics and complex therapeutics. Its activities include development through commercialisation. 

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Shilpa Medicare Share Price Performance  

As of September 11, 2026, 3:30 pm, Shilpa Medicare share price closed at ₹959.05, up 2.04% from the previous closing price. 

Conclusion 

The SEC has approved the grant of marketing authorisation for OERIS™. The company’s stated next step is commercial launch in India after the final CDSCO authorisation. 

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