Shilpa Medicare receives SEC approval for Oeris injection lasting up to 120 hours
核心洞察
Shilpa Medicare (搜索) received final SEC-CDSCO approval for marketing authorization of Oeris (搜索), an ondansetron extended-release injection at 100 mg/mL, in India.
Oeris (搜索) is described as the world's first once-weekly extended-release injectable ondansetron, delivering sustained antiemetic action for up to 120 hours from a single dose.
The company holds Indian patent protection for the formulation until 2039 and has finalized plans for commercial launch in India.
Shilpa Medicare (搜索) Limited has received final approval from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (搜索) (CDSCO) for marketing authorization of Oeris (搜索)™ (Ondansetron Extended-Release Injection, 100 mg/mL) in India. The company describes it as the world's first once-weekly extended-release injectable ondansetron formulation, providing sustained antiemetic action for up to 120 hours (5 days) from a single administration. Commercial launch plans in India have been finalized, and domestic patent protection covers the novel therapeutic until 2039.
The approval is positioned as validation of Shilpa Medicare (搜索)'s R&D capabilities in high-value Novel Drug Delivery Systems (NDDS). By moving from frequent daily ondansetron dosing to a single weekly injection, Oeris (搜索) is designed to eliminate the need for multiple daily doses or oral therapies in oncology supportive care, addressing compliance hurdles in chemotherapy-induced nausea and vomiting (搜索) (CINV) management. The company also cites a foundation for upcoming international registrations via the US FDA 505(b)(2) pathway.
The clearance follows positive Q1 FY27 results declared on August 5, 2026, with consolidated revenue from operations of ₹466 crore, up from ₹321.5 crore a year earlier, and net profit of ₹101 crore, a 115% year-on-year increase. Risks cited include physician adoption of a premium novel injection over generic short-acting antiemetics, execution on global filings, and the Corporate Insolvency Resolution Process admitted against wholly owned subsidiary FTF Pharma Private Limited (搜索) on September 9, 2026.
Source: Sahi