Biocon Ltd. has announced that its first manufacturing facility in the US, located in Cranbury, New Jersey, has successfully undergone a critical Good Manufacturing Practices (GMP) inspection by the US Food and Drug Administration (FDA).
The inspection, a mandatory requirement for supplying the regulated U.S. market, concluded with a single observation. According to the company, this observation is minor and will be addressed within the stipulated time frame. Biocon has assured stakeholders that the outcome is not expected to impact current or planned business operations from the site.
The state-of-the-art Cranbury facility was inaugurated in September and represents a strategic investment to strengthen Biocon's footprint in a key international market. The site is designed to enhance supply chain resilience and enable faster access to the company's vertically integrated portfolio of products for patients across the region.
"The Cranbury facility is a strategic asset that will bring our high-quality, affordable therapies to patients in the US more efficiently and reliably," the company said in an exchange filing.
The facility is already operational, with some products having been commissioned from the site. With several additional product launches in the pipeline, the New Jersey plant is poised to play a pivotal role in Biocon's mission to expand global access to essential medicines.
The Cranbury facility represents a strategic advancement for the Company’s US operations, enabling faster access to essential therapies, enhanced supply reliability and a stronger connection with partners and healthcare providers, ultimately benefitting patients across the United States.
Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc. in 2023 and has since invested over $30 million to establish a state-of-the-art plant with an annual production capacity of 2 billion tablets. A few products have already been commercialized from the site, with several more in the pipeline. This investment helps Biocon diversify its manufacturing base, strengthen its supply chain and accelerate the expansion of its global footprint.
