Shilpa Medicare announces submission of NDA for Oxylanthanum Carbonate to USFDA by Unicycive Therapeutics

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-09-05T11:20:08+05:30 | Updated On 5 Sept 2024 11:20 AM IST

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.

Commenting on the event, Vishnukant Bhutada – Managing Director, Shilpa Medicare Limited mentioned, “Submission of this NDA demonstrates delivery of high quality developmental services by Shilpa to its 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.”

Read also: Shilpa Medicare successfully completes Phase 3 studies of SMLNUD07 - NorUDCA

Shilpa is an integrated pharmaceutical group with business interests in niche Oncology & Nononcology APIs, Peptides, Polymers, differentiated finished dosage formulations including orally dispersible films & transdermal patches along with carefully crafted biological portfolio. Shilpa also provides end-to-end CDMO services to global pharmaceutical companies across all its business segments based on its R&D and manufacturing capabilities backed by four R&D units and seven manufacturing facilities.

Read also: Shilpa Medicare gets USFDA nod for Bortezomib Injection for multiple myeloma

unicycive therapeuticsUSFDAoxylanthanum carbonatehyperphosphatemiachronic kidney disease

Ruchika Sharma

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

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: drkohli@medicaldialogues.in. Contact no. 011-43720751