Jubilant’s Radiopharma business receives NDA approval for Technetium Mertiatide Injection
Jubilant Pharmova Limited’s wholly owned subsidiary Jubilant Draximage Inc (‘Company’) today announced that it has received approval from the US FDA 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.
This approval is effective from Jan 30, 2023.
About Jubilant Radiopharma
Jubilant Radiopharma, a division of Jubilant Pharma Ltd., is an industry-leading radiopharmaceutical business that comprises development, manufacturing and commercialisation of products through Radiopharmaceuticals business and distribution through the Radiopharmacies business. Jubilant Radiopharma’s manufactured products are used in the diagnosis, treatment and monitoring of various diseases with specialisation in lung, thyroid, bone and cardiac imaging products as well as in thyroid disease therapy. The division’s Radiopharmacies business is the second largest radiopharmacy network in the US with 46 pharmacies distributing nuclear medicine products to the largest national Group Purchasing Organisations (GPOs), regional health systems, stand-alone imaging centres, cardiologists and hospitals. This business has over 30 years of experience in serving the US nuclear medicine community and its current geographical reach enables it to serve over four million patients yearly. The Radiopharmacies business complements the Company’s niche Radiopharmaceuticals business and provides it with direct access to hospital networks. Jubilant Radiopharma is focused on developing, manufacturing, commercializing and distributing high quality and sustainable diagnostic and therapeutic agents for the sole purpose of “Improving Lives Through Nuclear Medicine” on a global scale.
About Jubilant Pharma Limited
Jubilant Pharma Limited (JPL), a Company incorporated under the laws of Singapore and a wholly-owned subsidiary of Jubilant Pharmova Limited, is an integrated global pharmaceutical company engaged in manufacturing and supply of Radiopharmaceuticals with a network of radio-pharmacies in the US, Allergy Immunotherapy, Contract Manufacturing of Sterile Injectables and Non-sterile products and Solid Dosage Formulations through five manufacturing facilities that cater to all the regulated market including USA, Europe and other geographies. The Company has a team of around 3,500 multicultural people across the globe and is committed to delivering value to its customers spread across over 75 countries. It is well recognized as a 'Partner of Choice' by leading pharmaceutical companies globally. For more info please visit www.jubilantpharma.com
About Jubilant Pharmova Limited
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. 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. Jubilant Pharmova Limited has a team of over 6,000 multicultural people across the globe. The Company is well recognized as a ‘Partner of Choice’ by leading pharmaceuticals companies globally. For more information, please visit: www.jubilantpharmova.com
For more information, please contact:
For Investors
Vineet V Mayer
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