Shilpa Medicare has successfully secured GMP certification from AGES, Austria for its Unit 4 facility in Jadcherla, Telangana. According to the company's regulatory filing on October 10, the unit was inspected by AGES from July 27, 2026 to July 30, 2026, following which the Austrian agency issued the certification. Unit 4 is engaged in manufacturing, testing and distribution of finished dosage forms, including sterile injections and non-sterile tablets and capsules, with products now approved for exports to Europe and rest-of-world markets. The certification validates the unit's compliance with European regulatory standards and ensures the company can continue or expand commercial activities in Europe without regulatory hindrance.
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.
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 the company with exclusive rights for the extended-release chemotherapy anti-nausea injection. The company is headquartered in Raichur, Karnataka.
On the NSE, Shilpa Medicare shares closed at ₹1,025.70, up ₹0.40, or 0.04%. The modest gain reflects investor response to the dual regulatory approvals, with the GMP certification from Austria's AGES and the SEC approval for OERIS injection in India. The company's stock has shown strong historical performance with 186.07% gains over one year and 243.11% returns over five years, demonstrating sustained investor confidence in the company's regulatory compliance and export capabilities.
