Shilpa Medicare's Novel Injectable OERIS™ Gets SEC Marketing Approval
Shilpa Medicare received SEC approval for OERIS™, the world's first extended-release ondansetron injectable, offering 5-day antiemetic action. The product is patented until 2039 and will launch in India. This development aims to improve patient convenience and healthcare efficiency.
The approval of a first-of-its-kind product with patent protection and a clear commercialization plan is expected to have a substantial positive impact on the company's market position and financial performance.
The company received final approval for a novel product, which is a significant positive development for its oncology portfolio and future revenue.
Shilpa Medicare Limited announced on September 11, 2026, that it has received final approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) for the marketing authorization of OERIS™ (Ondansetron Extended-Release Injection, 100 mg/mL).
OERIS™ is described as the world's first extended-release ondansetron injectable formulation, designed to provide sustained antiemetic action for up to 120 hours (5 days) after a single administration. This marks a first-of-its-kind approval in both India and globally. The product enjoys patent protection in India until 2039.
The SEC's approval is based on the successful completion of a Phase III trial that evaluated the safety and efficacy of OERIS™ for preventing and controlling chemotherapy-induced nausea and vomiting (CINV). The formulation aims to enhance patient convenience and healthcare staff efficiency by reducing injections to a single dose every five days.
Following the marketing authorization, Shilpa Medicare plans to launch OERIS™ commercially across India. Mr. Vishnukant Bhutada, Managing Director, stated that this approval is a pivotal moment in redefining supportive cancer care and solidifies the company's differentiated oncology portfolio, moving it closer to its vision of becoming a global leader in specialty pharmaceuticals.
What to do with a filing like this
Shilpa Medicare Limited filed this with the NSE as a statutory disclosure, categorised under product launches. It is a primary document, not a recommendation, and the desk marks it high impact, which is the band that most often changes something.
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See the model portfoliosA plain-language summary of a public exchange filing by Shilpa Medicare Limited. Read the original for the full detail.