Shilpa Medicare’s Unit 4 in Jadcherla, Telangana, has received GMP certification from AGES, Austria, following a successful inspection, the company said in a regulatory filing on October 10.
The unit was inspected by AGES, Austria, from July 27, 2026 until July 30, 2026. Following the inspection, the Austrian agency issued the GMP certification.
According to the filing, Unit 4 is engaged in the manufacturing, testing and distribution of finished dosage forms. These include sterile injections and non-sterile tablets and capsules. The products are supplied to Europe and the rest of the world markets.
The company is headquartered in Raichur, Karnataka.
Also read: Shilpa Medicare gets final approval for 5-day chemotherapy anti-nausea injection
OERIS injection approval
In a separate development, 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.
The formulation is designed to provide protection against chemotherapy-induced nausea and vomiting for up to 120 hours, or five days, after a single dose.
The approval follows the successful completion of a Phase III clinical trial evaluating the drug’s safety and efficacy in patients undergoing moderately to highly emetogenic chemotherapy.
Also read: Shilpa Medicare recalls 27,923 chemotherapy drug vials in US over discolouration
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.
On the NSE, Shilpa Medicare shares closed at ₹1,025.70, up ₹0.40, or 0.04%.