What Approval Was Received?
Shilpa Medicare Limited has secured final approval from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) for marketing authorization of its novel complex injectable, OERIS. The approval pertains to Ondansetron Extended-Release Injection at a concentration of 100 mg/mL. OERIS is designed as the world's first extended-release injectable formulation of ondansetron, capable of providing sustained antiemetic action for up to 120 hours following a single administration.
This regulatory milestone follows the successful completion of a multicenter, randomized, double-blind Phase III trial evaluating safety and efficacy in patients receiving chemotherapy.
Why This Approval Matters
- Eliminates the need for repeat injections by providing five days of protection per dose
- Targets the prophylaxis and control of chemotherapy-induced nausea and vomiting (CINV)
- Enhances patient convenience and optimizes healthcare staff efficiency in oncology wards
- Provides a significant competitive moat with Indian patent protection lasting until 2039
- Strengthens the company's differentiated oncology portfolio and advanced drug delivery systems
Path to Market and Financial Position
Shilpa Medicare intends to initiate a commercial launch of OERIS across India immediately upon receiving the final marketing authorization from the CDSCO. Financially, the company remains a strong performer with a trailing twelve-month net profit of ₹297.32 crore and a quarterly net profit growth of 115.16% year-on-year. The company's focus on high-value specialty and biologics programs is reflected in its trailing twelve-month revenue of ₹1,682.47 crore.
With a Piotroski score of 7 and a 125.18% price return over the last year, the company continues to scale its integrated CDMO and innovator-partnered pharmaceutical solutions.
Strategic Development
Final approval from SEC for grant of marketing authorization for OERIS, marks a pivotal moment in our journey to redefine supportive cancer care. It underscores our dedication to developing complex, patient-first formulations that address real clinical gaps.
