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  • Novartis expands...

Novartis expands production of Pluvicto with addition of its largest, most advanced radioligand therapy manufacturing facility in Indianapolis

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 7 Jan 2024 9:00 AM  |  Updated On 27 March 2024 7:04 AM
Novartis oral Fabhalta gets USFDA nod for adults with C3 glomerulopathy
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Basel: Novartis has announced that it has received approval from the US Food and Drug Administration (FDA) for commercial manufacturing of Pluvicto (INN: lutetium (177Lu) vipivotide tetraxetan / USAN: lutetium Lu 177 vipivotide tetraxetan) at its new large-scale, state-of-the-art radioligand therapy (RLT) manufacturing facility in Indianapolis, Indiana, United States.

The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world. The Indianapolis site represents the next phase of RLT manufacturing growth as this new addition brings substantial supply increases for the foreseeable future.

“The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” said Steffen Lang, President, Operations, Novartis. “Adding a second US RLT facility, our largest and most advanced yet, into our manufacturing network underscores our commitment to ensure a consistent and reliable experience for patients and their healthcare teams for years to come. We also recently announced plans to build our manufacturing capabilities in Sasayama, Japan and Haiyan, Zhejiang, China, as we continue to look for opportunities to further expand our worldwide reach.”

The Indianapolis facility, centrally located within the US, is purpose-built from the ground up to manufacture RLTs now and into the future and includes space for continued line expansion including plans for fully automated lines, a first for the radiopharmaceutical industry. The new site will supply the growing demand for patients in the US and eventually in Canada, upon approval, together with the company’s Millburn, New Jersey location. The site in Ivrea, Italy will continue to supply patients in and outside the US while the facility in Zaragoza, Spain will solely provide RLTs for patients outside the US.

Novartis recently announced that supply of Pluvicto is unconstrained. Having doubled weekly production, Novartis currently has more than sufficient supply to treat patients within two weeks of diagnosis, which is important for these patients with advanced disease who may need treatment quickly.

With four active manufacturing facilities, and a RLT production capacity of 250,000 doses in 2024 and beyond, Novartis continues to expand its worldwide RLT manufacturing network as ongoing clinical trials may present the potential to bring Pluvicto and Lutathera to more patients in earlier lines of treatment.

Read also: Voyager Therapeutics enters Capsid license agreement with Novartis to advance novel gene therapies

novartisnovartis newsUSFDApluvicto
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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