Shilpa Medicare And Unicycive Submit New Drug Application To U.S. FDA

Shilpa Medicare Ltd. announced that Unicycive Therapeutics, Inc. has submitted a new drug application to the U.S. FDA for a project they worked on together.

The new drug application was submitted for oxylanthanum carbonate—a treatment for high phosphate levels in patients with chronic kidney disease who are on dialysis, according to an exchange filing on Wednesday.

Unicycive has collaborated with Shilpa Medicare for the development and manufacturing services. It includes creating active pharmaceutical ingredients and formulations and supplying the final product, said the filing.

Unicycive has signed a long-term agreement with the company for manufacturing and supply starting in the first quarter of fiscal 2025-26.

“Submission of this NDA demonstrates delivery of high-quality developmental services by Shilpa to its CDMO (Contract Development and Manufacturing Organisation) customers and strengthens its credentials as a one-stop reliable partner for all the CDMO requirements of global pharma companies," according to Vishnukant Bhutada, managing director at Shilpa Medicare Ltd.

Shares of Shilpa Medicare closed 6.03% higher at Rs 810.60 apiece, compared to a 0.25% rise in the benchmark BSE Sensex.