By admin 
Shilpa Medicare shares hit a fresh record high of ₹824.0 apiece on Wednesday, September 4, after it said it has submitted its new drug application (NDA) to the USFDA for Oxylanthum Carbonate, which is used for treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis.
Shilpa Medicare submitted the NDA to the USFDA by Unicycive Therapeutics, its first regulatory submission from CDMO partnered projects.
The company said the NDA submission package is based on on three clinical studies, multiple pre-clinical studies and the specifications and practices related to chemistry, manufacturing and controls.
Unicycive has partnered with Shilpa Medicare to provide end-to-end Contract Development and Manufacturing Organisation (CDMO) services, from development of Active Pharmaceutical Ingredients (APIs) and formulation to supply of finished dosage form. It has entered a long term manufacturing and supply agreement with SML for all its commercial requirements in the market starting from the first quarter of FY26.
The CDMO customer will also place orders for additional tablets for delivery between December 31, 2025 and June 30, 2026. Shilpa Medicare will receive income from these supply agreements.
Additionally, the company will also receive $10 million as milestone income which will be spread over filing, approval and launch of the said product.
Shilpa Medicare shares were up 6.2% at ₹812.75 apiece at 2.40 pm on Wednesday, September 4. The stock has gained 153.99% this year, so far.