Shilpa Medicare hits life high on submission of new drug application to USFDA

Shilpa Medicare (SML) climbed 6.12% to Rs 811.25 after the company announced that it has submitted new drug application (NDA) to U.S. Food and Drug Administration (USFDA) for Oxylanthanum Carbonate.

The said drug is used for treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.

In an exchange filing, the company said that Unicycive Therapeutics, Inc. has announced submission of NDA to USFDA for Oxylanthanum Carbonate.

Unicycive has partnered with SML to provide end-to-end contract development and manufacturing organisations (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 Q1FY 2025-26.

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 Oxylanthanum Carbonate in CKD patients on dialysis), multiple preclinical studies, and the specifications and practices related to chemistry, manufacturing and controls (CMC).

Vishnukant Bhutada, managing director of Shilpa Medicare, said 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

Raichur-based Shilpa Medicare is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.

The company reported consolidated net profit of Rs 14.06 crore in Q1 FY25, steeply higher than Rs 1.18 crore posted in Q1 FY24. Revenue from operations grew by 12.4% year on year to Rs 292.51 crore in the quarter ended 30 June 2024.

The counter hit an all time high of Rs 823.95 in todays intraday session.

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