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Shilpa Medicare announces submission of NDA for Oxylanthanum Carbonate to USFDA by Unicycive Therapeutics
![Shilpa Medicare announces submission of NDA for Oxylanthanum Carbonate to USFDA by Unicycive Therapeutics Shilpa Medicare announces submission of NDA for Oxylanthanum Carbonate to USFDA by Unicycive Therapeutics](https://medicaldialogues.in/h-upload/2024/01/20/750x450_230602-shilpa-medicare-50.webp)
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.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751