Shilpa Medicare submits new drug application with USFDA

4 Sep 2024 , 08:59 PM

Shilpa Medicare Ltd. shares reached a record high of ₹824 per share on Wednesday, September 4, following the submission of a new drug application (NDA) to the USFDA for Oxylanthum Carbonate, a therapy for hyperphosphatemia in chronic kidney disease patients on dialysis.

Shilpa Medicare submitted the NDA to the USFDA through Unicycive Therapeutics, making it the first regulatory application from CDMO-partnered initiatives.

According to the firm, the NDA submission package is based on three clinical trials, many pre-clinical investigations, and specifications and practices for chemistry, production, and controls.

Unicycive has teamed with Shilpa Medicare to deliver end-to-end Contract Development and Manufacturing Organisation (CDMO) services, ranging from Active Pharmaceutical Ingredient (API) development and formulation to completed dosage form supply. It has signed a long-term production and supply deal with SML for all of its commercial needs in the market beginning in the first quarter of FY26.

The CDMO customer will additionally order additional tablets for delivery between December 31, 2025, and June 30, 2026. Shilpa Medicare will benefit financially from these supply deals.

Furthermore, the company will get $10 million in milestone income, which will be distributed over the filing, approval, and marketing of the aforementioned product.

At around closing, Shilpa Medicare was trading 6.22% higher at ₹812.85, against the previous close of ₹765.25 on NSE. The counter touched an intraday high and low of ₹824.05, and ₹752.45, respectively.

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