Jubilant Radiopharma business receives ANDA approval for Technetium Sulfur Colloid Injection

Published On 2023-11-14 07:00 GMT   |   Update On 2023-11-14 12:08 GMT
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NoidaJubilant Pharmova Limited’s wholly owned subsidiary Jubilant Draximage Inc ('Company') has announced that it has received approval from the US FDA with regards to the Company’s abbreviated new drug application (ANDA) submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C) for kit for the preparation of Technetium (Tc 99m) Sulfur Colloid Injection.

For this approval, Jubilant is eligible for 180 days of exclusivity through the ‘Competitive Generic Therapy’ designation from the US FDA.

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Technetium Sulfur Colloid Injection is used in the localization of metastatic lymph nodes in patients with breast cancer and melanoma, imaging of areas of the liver, spleen and bone marrow, and studies of esophageal transit, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents.

This approval is effective from Nov 9, 2023.

Speaking on the announcement, Pramod Yadav, CEO, Jubilant Radiopharma business said, “At Jubilant, we are glad to announce approval for Sulfur Colloid, which will improve availability of this critical radiopharmaceutical to patients and healthcare professionals. Technetium Sulfur Collid is our second product to be launched in FY24 after the approval and launch of Technetium Mertiatide Injection in Q1’FY24 and highlights our strong focus on the nuclear medicine business and commitment towards improving patient lives.”

Read also: Jubilant Draximage bags USFDA nod for Technetium Mertiatide Injection

Jubilant Pharmova 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. Jubilant Therapeutics (JTI) invested for in-house Proprietary Novel Drugs business and is an innovative biopharmaceutical company developing breakthrough therapies in the area of oncology and auto-immune disorders. 


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