Shilpa Medicare announces submission of NDA for Oxylanthanum Carbonate to USFDA by Unicycive Therapeutics
Karnataka: Unicycive Therapeutics, Inc. has announced the submission of New Drug Application (NDA) to United States Food and Drug Application (U.S. FDA) for Oxylanthanum Carbonate for Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease(CKD) on Dialysis.
The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the specifications and practices related to chemistry, manufacturing and controls (CMC).
Unicycive has partnered with Shilpa Medicare Limited (SML) to provide end-to-end CDMO services right from development of APIs & formulation to supply of finished dosage form. Unicycive has entered into long term manufacturing and supply agreement with SML for all its commercial requirements in the market starting from Q1 – FY 2025-26.
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