Key Milestone for Shilpa Medicare’s CDMO Business with Binding Order

On July 4, 2024, Shilpa Medicare Limited (SML) announced in a stock exchange filing that its CDMO (contract development and manufacturing organisation) customer, Unicycive Therapeutics, Inc., has reported positive results from the pivotal clinical trial of Oxylanthanum Carbonate (OLC), a new chemical entity (NCE) molecule with potential treatment for hyperphosphatemia in chronic kidney disease patients. Unicycive plans to file a New Drug Application for OLC by mid-2024, with potential approval expected by mid-2025.

Shilpa Medicare has partnered with Unicycive to provide comprehensive CDMO services, including the development and supply of APIs and the production of finished dosage forms. Following the successful clinical trials, Unicycive has entered into a long-term manufacturing and supply agreement with Shilpa Medicare, with a binding purchase order for the supply of OLC tablets by June 30, 2025. Additionally, Unicycive has committed to placing orders for additional tablets to be delivered between December 31, 2025, and June 30, 2026.

Beyond the supply arrangement, Shilpa Medicare will receive $10 million in milestone payments spanning the filing, approval, and launch of the product. Anticipating increased product demand, Unicycive will also fund the establishment of a new manufacturing block at Shilpa’s site.

The company stated that for them this partnership represents a significant milestone, reinforcing its position as a reliable one-stop partner for global pharma companies’ CDMO needs. This includes development, manufacturing, supply, and other chemistry, manufacturing, and controls (CMC) services.

About Shilpa Medicare Limited

Shilpa Medicare Limited is involved in the manufacturing of niche APIs, formulations, and intermediates, and it also takes up contract research and manufacturing services for a few customers. The company’s formulation products consist of 19 oral solid dosage forms under SML, 16 injectable dosage forms and 13 formulations under SML’s wholly-owned subsidiary Shilpa Therapeutics.

On July 5, 2024, the share price of Shilpa Medicare Ltd opened at ₹601.00, touching the day’s high at ₹669.00, as of 9:36 AM on the NSE.

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