Shilpa Medicare says US FDA inspection at Hyderabad unit ends with one observation

Pharma firm Shilpa Medicare Ltd on Friday (September 18) said a United States Food and Drug Administration (USFDA)surveillance inspection at its Analytical Services Division in Hyderabad concluded with one procedural observation.

The inspection was conducted from September 16 to September 18, 2026, at the company’s Unit VII, Analytical Services Division, located at IDA Mallapur, Nacharam, Hyderabad, Telangana. The company said the observation was neither a repeat observation nor related to data integrity.

Shilpa Medicare said it will submit a comprehensive response to the USFDA within the stipulated timeline, addressing the observation through appropriate corrective and preventive actions.

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The company said it does not expect the development to have any material impact on its current business operations or existing supplies from the facility.

"We will submit a comprehensive response to the USFDA within the stipulated timeline, addressing the observation with appropriate corrective and
preventive actions. The company is committed to maintaining the highest standards of quality and compliance across all its operations," it said.

Last week, Shilpa Medicare said it had 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.

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.

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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.

Shares of Shilpa Medicare Ltd ended at ₹1,028.65, up by ₹71.25, or 7.44%, on the BSE.

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