Jubilant Draximage bags USFDA nod for Technetium Mertiatide Injection

Published On 2023-02-01 06:45 GMT   |   Update On 2023-02-01 06:45 GMT
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Noida: Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant Draximage Inc has announced that it has received approval from the US Food and Drug Administration (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.

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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.  

Read also: Jubilant Pharma arm to raise Rs 3,186 crore loan from Standard Chartered Bank to repay debt

The product enables providing renal function, split function, renal angiograms, and renogram curves for whole kidney and renal cortex. This approval is effective from Jan 30, 2023.  

Read also: Jubilant Therapeutics gets USFDA clearance for JBI-778 to treat solid tumors with brain metastases, primary brain tumors

Jubilant Pharmova Limited (formerly Jubilant Life Sciences Limited) 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. 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 US FDA approved facility in Nanjangud, Karnataka.   
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