Shilpa Medicare has received final approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) to market OERIS, its extended-release ondansetron injection, in India. According to reports from CNBC TV18 and Business Standard, the company said OERIS is designed to be the world's first extended-release ondansetron injectable formulation, providing sustained anti-nausea protection for up to 120 hours, or five days, after a single administration. The approval follows the successful completion of a multicentre, randomised, double-blind Phase III trial evaluating the drug's safety and efficacy in preventing and controlling chemotherapy-induced nausea and vomiting in patients undergoing moderately to highly emetogenic chemotherapy. As per latest reports, this marks a first-of-its-kind approval in both India and globally, establishing Shilpa Medicare as a pioneer in extended-release ondansetron formulations.
The formulation is aimed at reducing repeat injections to a single dose every five days, potentially making treatment more convenient for patients while also easing the workload for healthcare staff. As reported by CNBC TV18, Shilpa Medicare plans to launch OERIS commercially across India after receiving the final marketing authorisation. The product is protected by a patent in India until 2039, providing significant intellectual property protection for the company's innovative formulation. The commercialization of OERIS is set to strengthen Shilpa Medicare's high-margin formulations business, which registered exceptional growth in Q1 FY27. Upon receipt of final marketing authorization from the CDSCO, the company plans to initiate commercial launch across India, positioning OERIS as a transformative product in the supportive cancer care segment.
The development comes as the drugmaker continues to see strong growth across its business. According to CNBC TV18, Shilpa Medicare reported record revenue and operating income in the June quarter, with consolidated revenue rising 45% year on year to ₹466 crore. Net profit more than doubled to ₹101 crore from ₹47 crore a year earlier. The company's consolidated net profit increased to ₹101 crore in Q1 FY27 from ₹47 crore in Q1 FY26, representing an 115% year-on-year growth. Consolidated EBITDA rose to ₹136.2 crore in Q1 FY27 from ₹91.6 crore in Q1 FY26, showing 48.6% YoY growth. The approval provides a patented, high-margin domestic portfolio addition with zero direct competitors for up to 120 hours of therapeutic action.
The US business also gained traction from its niche portfolio, while European formulations revenue rose 84% to ₹57 crore. As reported by CNBC TV18, domestic formulations were even stronger, growing 179% from a year earlier. Vishnukant Bhutada, Managing Director of Shilpa Medicare, said the approval marks a 'pivotal moment' in the company's effort to redefine supportive cancer care and strengthens its oncology portfolio. The transition from a generic active pharmaceutical ingredient (API) manufacturer to an innovation-driven specialty formulations player reaches an inflection point with the OERIS approval.
Shares of Shilpa Medicare were trading at ₹953.70 on the NSE, up 1.47%, or ₹13.80, as of 2:15 pm on Friday, according to CNBC TV18. The stock's latest move comes after a strong run in the company's earnings, with the June quarter marking another step-up in revenue and profitability. The positive market response reflects investor confidence in the company's innovative drug development capabilities and strong financial performance across multiple business segments. The approval provides a solid foundation for upcoming international registrations via the US FDA 505(b)(2) pathway, creating premium valuation opportunities for the company.
