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The basics:

• Biocon opens first U.S. manufacturing site in Cranbury, NJ
• $30M investment expands capacity to 2 billion tablets annually
• Facility will produce oral solid dosage forms for chronic conditions
• Plans include job growth, supply chain resilience, and future expansion

An India-headquartered global biopharmaceutical company is making a big bet on the Garden State. Biocon Ltd. focuses on enhancing affordable access to complex therapies for chronic conditions, such as diabetes, cancer and autoimmune diseases.

Earlier this month, the company opened its first U.S. manufacturing facility in Cranbury. In 2023, Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc. Since, it’s invested more than $30 million to modernize and expand the site, which now has the capacity to produce up to 2 billion tablets annually. Biocon’s wholly owned subsidiary Biocon Generics Inc. operates the site.

In fact, a few products have been commercialized from the state-of-the-art facility.

A variety of officials, key stakeholders and leaders were on hand for the Sept. 10 inauguration, including Gov. Phil Murphy. “We are incredibly grateful that Biocon has decided to open its first U.S. manufacturing facility in the Garden State,” Murphy said. “For years, Biocon has provided high-quality medicines and treatments to millions of patients across the globe. This state-of-the-art facility marks a significant moment in Biocon’s global expansion and reinforces New Jersey’s reputation as the medicine chest to the world.”

Company leaders stressed that the Cranbury facility represents a strategic advancement for its U.S. operations that will enable faster access to essential therapies, as well as enhance supply reliability and a stronger connection with partners and health care providers. Biocon says it will ultimately benefit patients across the country.

“Biocon’s first U.S. FDA [Food and Drug Administration] approved formulations facility in New Jersey marks a new chapter in our journey of global expansion,” said Kiran Mazumdar-Shaw, Biocon Group chair. “More than a milestone, it is a reaffirmation of our purpose to serve patients wherever they are. Gov. Phil Murphy’s presence at the inauguration highlights the importance of Biocon’s role in fostering innovation, creating job opportunities, and strengthening the U.S. health care ecosystem.

“This facility reflects our long-term commitment to deeper engagement with health care providers, innovators, and communities to build a healthier and equitable future.”

“This strategic investment brings us closer to patients, health care providers and our partners in this important market,” said Siddharth Mittal, CEO and managing director, Biocon Ltd. “The proximity allows us to deliver our vertically integrated, high-quality medicines more efficiently to patients across the United States and other markets, ensuring supply chain resilience and enabling us to advance our mission of expanding access to affordable therapies worldwide.”

Why New Jersey?

Following the opening of the Cranbury facility, NJBIZ connected with Mittal to further discuss the investment in New Jersey. He noted that this is Biocon’s first manufacturing investment in the United States.

“While we have been commercializing our drugs and services here for more than two decades – including generics, biosimilars, and partnerships with multinational and retail channels – the Cranbury facility marks a strategic expansion into local manufacturing,” Mittal told NJBIZ. “We chose New Jersey for several reasons. First, the state has long been a hub for pharmaceutical manufacturing, particularly small molecules, and offers strong access to a skilled talent pool.

“Second, this specific opportunity presented itself when Eywa Pharma’s facility became available, and acquiring and expanding it made strong financial sense. Finally, the pandemic reinforced the importance of supply chain resilience,” he continued.

“Having an oral solid dosage facility within the Biocon group located in New Jersey allows us to be closer to patients and customers in the U.S., strengthening both our operations and long-term growth strategy.”

Mittal also cited the life sciences ecosystem. “New Jersey stood out because of its strong concentration of manufacturing generics and small molecules,” he explained. “This facility offered the right opportunity and strategic fit, making it the best choice for our investment.”

Getting to work

So what will be manufactured at the site?

Mittal noted that the facility currently only produces oral solid dosage forms and not biologics. “However, as part of future expansion into the U.S., we could look at biosimilar manufacturing in the U.S. as well,” he said. “Biocon’s generics business is focused and concentrated, rather than having a broad portfolio like some of our peers. Our strategy emphasizes leveraging our vertical integration and offering continuity of supply.

“Currently, we are commercial with about 25 OSD in the U.S. and we are already manufacturing four of these products from this site. We will keep adding other products from our portfolio to this site and also file for new products from here,” Mittal continued. “Some of these therapy areas we focus on are based on chronic disease segments such as diabetes, cardiovascular, immunotherapy and metabolic therapies.

“We are looking to add controlled substance drug products to this site.”

Mittal said the facility enables the company to diversify its supply chain and to participate in government programs. “And take a long-term view toward expanding our portfolio in the U.S. market,” he said.

Growing workforce

Mittal also detailed the jobs created and skills required. “The Cranbury facility currently has approximately 60 employees — 40 joined through the acquisition of Eywa, while Biocon hired the remainder,” Mittal explained. “The facility has plans to grow to around 100 employees, once fully operational, with demand for roles across manufacturing and packaging operations, quality control and supply chain management.”

Working with New Jersey universities and workforce development programs for talent pipelines may also be in the cards.

“Biocon has a long history of collaborating with academic and training institutions across geographies, including through our flagship initiative, Biocon Academy, which has been instrumental in developing industry-ready talent for the biopharma sector in collaboration with the KEG institute in California,” Mittal said. “We are always open to exploring such opportunities globally.”

Mittal said the company has initiated a few discussions with certain institutions and the state government to see how this can be further expanded. “As we expand our operations and product portfolio in the region, building talent pipelines in collaboration with academia and workforce programs will certainly be an aspect we consider, based on specific requirements,” he said.

Broader strategy

“At present, our Cranbury facility is a key step in expanding our U.S. presence on the manufacturing side, but our broader strategy is to build a diversified global footprint,” Mittal explained. “With the majority of our infrastructure base in India, we have partnered with a lot of local and startup companies that have a strong R&D base or a differentiated portfolio based on their capabilities that do not overlap with ours.

“We have taken such products on joint development programs and commercialized them. We will continue to work in that direction.”

Mittal was also clear about how the new facility fits into the company’s plans.

“The Cranbury facility will play a key role in Biocon’s U.S. strategy, supporting local manufacturing of critical generic medicines, enhancing supply chain resilience, and strengthening our ability to serve patients and customers in North America,” he said.

“Over the next five-to-10 years, it is expected to be a central hub for growth in Biocon’s business in the U.S.”