Novartis Plans Major Manufacturing Expansion In U.S.A.

President Trump's tariff threat has motivated Swiss-based Novartis to announce a major change in manufacturing plans.  One point not widely considered: domestic manufacturing facilitates FDA inspections which assure pharmaceutical quality:

https://www.novartis.com/us-en/news/media-releases/novartis-plans-expand-its-us-based-manufacturing-and-rd-footprint-total-investment-23b-over-next-5-years

Novartis plans to expand its US-based manufacturing and R&D footprint with a total investment of $23B over the next 5 years
Apr 10, 2025

*   Expanded US manufacturing and R&D presence with investment in 10 facilities, including 7 brand new facilities
*   With new manufacturing capacity, Novartis will be able to produce 100% of its key medicines end-to-end in the US, a significant increase from current levels
*   Increased R&D presence planned includes a new research hub in the San Diego area to tap some of the best and brightest minds in America
*   Investment supports Novartis +5% cc CAGR 2024-2029 sales guidance

EAST HANOVER, N.J., April 10, 2025 /PRNewswire/ -- Today, Novartis, a leading global innovative medicines company, announced a planned $23 billion investment over 5 years in US-based infrastructure, ensuring all key Novartis medicines for US patients will be made in the United States. This commitment enables Novartis to expand on its current manufacturing, research and technology presence across the country with 10 facilities, including 7 brand new facilities, creating nearly 1,000 new jobs at Novartis and approximately 4,000 additional US jobs. The production capacity will cover both active pharmaceutical ingredients (API) and biologics drug substance, as well as secondary production and packaging.

Over the next 5 years, Novartis will:

*   Establish 1 biomedical research innovation hub in San Diego, CA, its second global R&D hub in the US
*   Build 4 new manufacturing facilities in soon-to-be-determined states, including 3 that will make biologics drug substances, drug products, device assembly and packaging, and 1 facility that will make chemical drug substances, oral solids dosage forms and packaging
*   Build 2 new radioligand therapy (RLT) manufacturing facilities in Florida and Texas
*   Expand 3 RLT manufacturing facilities in Indianapolis, IN, Millburn, NJ, and Carlsbad, CA

With these investments, Novartis will have manufacturing capacity in the US for all its core technology platforms, including small molecules and biologics. Novartis already manufactures its most innovative, advanced therapies in the US for patients in the US and around the world. This includes cutting-edge technology platforms like gene and cell therapy and RLT manufacturing. This new investment will bring internal manufacturing of the company's siRNA technology to the US for the first time and reflects a commitment to increase US manufacturing across its main therapeutic areas: oncology, immunology, neuroscience, and cardiovascular, renal and metabolic. With new manufacturing capacity, Novartis will be able to produce 100% of its key medicines end-to-end in the US, a significant increase from current levels.

"As a Swiss-based company with a significant presence in the US, these investments will enable us to fully bring our supply chain and key technology platforms into the US to support our strong US growth outlook. These investments also reflect the pro-innovation policy and regulatory environment in the US that supports our ability to find the next medical breakthroughs for patients," said Vas Narasimhan, CEO of Novartis. "We are prepared for shifts in the external environment and fully confident in our 2025 guidance, mid- to long-term sales growth outlook and 2027 core margin guidance of 40%+."

The investment includes a newly planned $1.1 billion research hub in San Diego, a state-of-the-art research facility that will provide world-class scientific infrastructure and drug discovery capabilities to enhance and strengthen the efforts of Novartis scientists working to reimagine the future of medicine. The new complex, expected to open between 2028 and 2029, will serve as the epicenter of the Novartis West Coast Biomedical Research presence, complementing existing hubs in Cambridge, MA, and Basel, Switzerland.

In addition, the company will be expanding RLT manufacturing with new facilities in Florida and Texas. Novartis is the only organization with a dedicated commercial RLT portfolio, and has established global expertise, with specialized supply chain and manufacturing capabilities across its network of RLT production facilities. To support growing demand for RLTs in the US, Novartis has already expanded production capabilities in Millburn, NJ, and a state-of-the-art facility in Indianapolis, IN, and is currently building a third US RLT manufacturing facility in Carlsbad, CA.

The US is a priority market for Novartis, and the company has taken numerous steps over its 200-year history to build its US infrastructure. Over the next 5 years, the total investment in Novartis US operations is expected to be nearly $50 billion, marking a clear demonstration of the company's focus on the US.