Shilpa Medicare Limited has received final approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) for its novel complex injectable, OERIST™ (Ondansetron Extended-Release Injection, 100 mg/mL). This marks the world’s first extended-release ondansetron injectable formulation, offering sustained antiemetic action for up to five days with a single administration. The approval is a significant milestone for the company’s oncology portfolio, with launch planned in India and patent protection until 2039.
Key Product Approval Secured
Shilpa Medicare Limited has announced a significant development in its product pipeline with the final approval granted by the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO). This approval is for the marketing authorization of its novel complex injectable, OERIST™ (Ondansetron Extended-Release Injection, 100 mg/mL).
Groundbreaking Formulation
OERIST™ is distinguished as the world’s first extended-release ondansetron injectable formulation. It is designed to provide sustained antiemetic action for an extended period of up to 120 hours (5 days) following a single administration. This innovative approach represents a first-of-its-kind approval in both India and globally, addressing a key need in patient care.
Clinical Efficacy and Patient Benefits
The SEC’s decision is based on the successful completion of a multicenter, randomized, double-blind Phase III trial. This trial evaluated the safety and efficacy of OERIST™ for the prophylaxis and control of chemotherapy-induced nausea and vomiting (CINV) in patients undergoing moderately-to-highly emetogenic chemotherapy. The formulation’s ability to reduce the need for repeat injections to a single dose every five days is expected to significantly enhance patient convenience and improve healthcare staff efficiency.
Market Launch and Future Outlook
Shilpa Medicare plans to initiate the commercial launch of OERIST™ across India upon receiving the final marketing authorization from the CDSCO. The product also benefits from patent protection in India until 2039, positioning it strongly in the market. Mr. Vishnukant Bhutada, Managing Director, Shilpa Medicare Limited, commented that this approval is a pivotal moment, underscoring the company’s dedication to developing complex, patient-first formulations and solidifying its differentiated oncology portfolio.
About Shilpa Medicare Limited
Shilpa Medicare Limited is a global pharmaceutical company and integrated CDMO. It offers end-to-end solutions across small molecules, biologics, and complex therapeutics, partnering with innovators for development through commercialization. The company has a growing focus on high-value specialty and biologics programs.
Source: BSE
