Unicycive submits NDA to USFDA for Oxylanthanum Carbonate
Unicycive Therapeutics, Inc. (NASDAQ: UNCY) announced the submission of NDA to U.S. FDA for Oxylanthanum Carbonate for treatment of hyperphosphatemia in patients with chronic kidney disease 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 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 Shilpa Medicare for all its commercial requirements in the market starting from Q1 - FY 2025-26.
Commenting on the event, Vishnukant Bhutada - Managing Director, Shilpa Medicare mentioned, Submission of this NDA demonstrates delivery of high quality developmental services by Shilpa to it CDMO customers and strengthens its credentials as a one-stop reliable partner for all the CDMO requirements of global pharma companies. We are very pleased to have partnered with a like-minded team of Unicycive to deliver path breaking treatments for patients suffering from chronic diseases.
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