This approval is effective from 30 January 2023.
Jubilant Pharmova's wholly owned subsidiary Jubilant Draximage Inc announced that it received approval from the US drug regulator (USFDA) with regards to the company's new drug application (NDA) submitted pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Kit for the Preparation of Technetium (Tc 99m) Mertiatide injection.The Tc 99m Mertiatide injection is used in the diagnosis of congenital and acquired renal abnormalities, renal failure, urinary tract obstruction, and calculi in adults and pediatric patients aged 30 days and older.
The product enables providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex.
Jubilant Pharmova (formerly Jubilant Life Sciences) is engaged in Radiopharma, Allergy Immunotherapy, CDMO of Sterile Injectable, Generics, Contract Research Development and Manufacturing (CRDMO) and Proprietary Novel Drugs businesses.
With a network of 46 radio-pharmacies in the US, Jubilant's Radiopharma business is engaged in manufacturing and supply of Radiopharmaceutical products and services.
On a consolidated basis, net profit of Jubilant Pharmova declined 96.16% to Rs 5.49 crore on 3% decline in net sales to Rs 1584.74 crore in Q2 September 2022 over Q2 September 2021.
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Shares of Jubilant Pharmova jumped 4.50% to Rs 351.95 on Tuesday, 31 January 2023.
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