Jubilant Pharmova Limited Announcement

Noida: Jubilant 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.

About Technetium Sulfur Colloid Injection

Technetium Sulfur Colloid Injection is used in:

• Localization of metastatic lymph nodes in patients with breast cancer and melanoma
• Imaging of areas of the liver, spleen, and bone marrow
• Studies of esophageal transit, gastroesophageal reflux, and detection of pulmonary aspiration of gastric contents

This approval is effective from Nov 9, 2023.

CEO's Statement

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.”

Related News

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

About Jubilant Pharmova Limited

Jubilant Pharmova Limited is engaged in:

• Radiopharma
• Allergy Immunotherapy
• CDMO of Sterile Injectable
• Generics
• Contract Research Development and Manufacturing (CRDMO)
• 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) cater 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.