Shilpa Medicare Limited (BSE: 530549 | NSE: SHILPAMED) has received final approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) for the grant of marketing authorization for OERIS™, an Ondansetron Extended-Release Injection, 100 mg/mLOERIS™ has been developed as an extended-release ondansetron injectable formulation designed to provide sustained antiemetic protection for up to 120 hours, or five days, following a single administration. The company said the approval represents a first-of-its-kind development for the formulation in India and globally.
The SEC approval for the grant of marketing authorization follows the successful completion of a multicenter, randomized and double-blind Phase III clinical trial. The study evaluated the safety and efficacy of OERIS™ for the prophylaxis and control of chemotherapy-induced nausea and vomiting in patients receiving moderately to highly emetogenic chemotherapy.
The formulation is designed to reduce the need for repeated injections by providing treatment through a single administration once every five days. This could improve convenience for patients while helping healthcare providers manage treatment delivery more efficiently. OERIS™ is planned for commercial launch in India following receipt of the final marketing authorization from CDSCO. The product also has patent protection in India until 2039.
Vishnukant Bhutada, Managing Director, Shilpa Medicare Limited, said, “Final approval from SEC for grant of marketing authorization for OERIS™ marks an important step in our efforts to strengthen supportive cancer care. The product reflects our focus on developing complex formulations that address specific clinical needs and improve the treatment experience for patients.” He added that the approval further strengthens Shilpa Medicare’s oncology portfolio and supports its focus on specialty pharmaceuticals and advanced drug delivery systems.
The development is also expected to add to the company’s portfolio of complex and differentiated pharmaceutical products. Shilpa Medicare has been expanding its presence in specialty medicines, biologics and complex therapeutic areas while supporting pharmaceutical development and manufacturing for customers in different markets.
Shilpa Medicare Limited is a global pharmaceutical company and integrated contract development and manufacturing organization. The company provides end-to-end solutions across small molecules, biologics and complex therapeutics. Its operations support partners through product development and commercialization, with an increasing focus on high-value specialty products and biologics programs. The company continues to invest in advanced drug delivery technologies and complex pharmaceutical formulations.
