Last Updated on December 31, 2023 by The Health Master
Noida: Jubilant Draximage Inc., a wholly owned subsidiary of Jubilant Pharmova Limited, has announced that the US Food and Drug Administration (USFDA) has approved the company’s new drug application (NDA) for the Kit for the Preparation of Technetium (Tc 99m) Mertiatide Injection that was submitted in accordance with section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA).
The Tc 99m Mertiatide Injection is used to diagnose calculi in adults and pediatric patients 30 days and older as well as congenital and acquired renal abnormalities, renal failure, and urinary tract obstruction.
With this product, it is possible to provide renal function, split function, renal angiograms, and renogram curves for the entire kidney and renal cortex. This approval is effective from Jan 30, 2023.
Jubilant Pharmova Limited, formerly known as Jubilant Life Sciences Limited, operates in the fields of radiopharma, allergy immunotherapy, contract research development and manufacturing (CRDMO), generics, and proprietary novel drugs.
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.
Its other businesses such as Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products, and Generics (Solid Dosage Formulations) caters to major regulated markets (USA, EU, and other geographies) through five manufacturing facilities.
The CRDMO segment (through Jubilant Biosys) provides collaborative research and partnership for Drug Discovery through two world-class research centers in India.
The company is also involved in the manufacturing of Active pharmaceutical Products (API) through a USFDA approved facility in Nanjangud, Karnataka.
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