Shares of Shilpa Medicare Ltd. (BSE: SHILPAMEDE) climbed 7.44% to ₹1,028.65 on Friday, a jump of ₹71.25, following a US FDA surveillance inspection that ended with a lone procedural observation.
The inspection, conducted from September 16‑18, 2026 at the company’s Unit VII Analytical Services Division in Hyderabad, was neither a repeat observation nor related to data integrity, the company confirmed. Shilpa Medicare said it will file a comprehensive response with corrective and preventive actions within the stipulated timeline.
In parallel, the company disclosed that it has received final approval from the Central Drugs Standard Control Organization’s Subject Expert Committee to market OERIS, its extended‑release ondansetron injection, in India. The Phase III trial, a multicentre, randomised, double‑blind study, demonstrated safety and efficacy in controlling chemotherapy‑induced nausea and vomiting for up to 120 hours.
OERIS is slated for commercial launch across India after the final marketing authorisation is secured, with a patent protection that extends to 2039. The company’s announcement was seen as a positive catalyst for the stock, given the potential to reduce repeat injections and streamline patient care.
Looking ahead, Shilpa Medicare plans to submit its FDA response by the end of the month and aims to launch OERIS within the next fiscal quarter. Investors will be watching the company’s earnings release for FY 2026‑27 to gauge the impact of the new product line on revenue and margin trends.