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.
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.
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.
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 development comes as the drugmaker continues to see strong growth across its business. 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.
Also Read: Shilpa Medicare Q1 Results: Highest quarterly revenue and EBITDA on record
The company’s novel products business doubled from the year-ago quarter, while revenue excluding licensing income grew 112%. Its API business grew nearly 15%, with both captive and non-captive revenue showing healthy growth.
The US business also gained traction from its niche portfolio, while European formulations revenue rose 84% to ₹57 crore. Domestic formulations were even stronger, growing 179% from a year earlier.
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. 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
