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Shilpa Medicare Submits NDA to U.S. FDA for Oxylanthanum Carbonate with Unicycive

Shilpa Medicare Ltd., an integrated pharmaceutical group, has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate for the treatment of Hyperphosphatemia in patients with Chronic Kidney Disease on Dialysis. This submission is a result of a partnership between Shilpa Medicare and Unicycive Therapeutics, Inc. (NASDAQ: UNCY), where Shilpa Medicare provides end-to-end CDMO services, including the development of APIs & formulation and the supply of finished dosage form. The partnership also includes a long-term manufacturing and supply agreement for all of Unicycive's commercial requirements in the market starting from Q1 — FY 2025-26.

• Shilpa Medicare and Unicycive Therapeutics partner for the submission of NDA for Oxylanthanum Carbonate.
• Shilpa Medicare to provide end-to-end CDMO services for Unicycive's commercial requirements.
• The partnership includes a long-term manufacturing and supply agreement starting from Q1 — FY 2025-26.
• Shilpa Medicare's submission based on data from three clinical studies and multiple preclinical studies.
• Shilpa Medicare's submission demonstrates its capabilities and reliability as a CDMO partner for global pharma companies.