Biocon Ltd. has successfully completed a critical Good Manufacturing Practices (GMP) inspection by the US Food and Drug Administration (FDA) at its first manufacturing facility in the US, located in Cranbury, New Jersey. The inspection, which is mandatory for supplying the regulated US market, resulted in a single minor observation that will be addressed within the stipulated time frame. The company has assured stakeholders that this outcome will not impact current or planned business operations from the site.
The Cranbury facility, which was inaugurated in September, is a state-of-the-art plant that represents a strategic investment to strengthen Biocon’s footprint in the US market. The site is designed to enhance supply chain resilience and enable faster access to the company’s portfolio of products for patients across the region. The facility is already operational, with some products having been commissioned from the site, and is expected to play a pivotal role in Biocon’s mission to expand global access to essential medicines.
The Cranbury facility has an annual production capacity of 2 billion tablets and has already commercialized a few products, with several more in the pipeline. 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. This investment helps Biocon diversify its manufacturing base, strengthen its supply chain, and accelerate the expansion of its global footprint.
The successful GMP inspection and the operationalization of the Cranbury facility mark a significant milestone for Biocon’s US operations. The company is now well-positioned to bring its high-quality, affordable therapies to patients in the US more efficiently and reliably. The facility will enable faster access to essential therapies, enhance supply reliability, and strengthen connections with partners and healthcare providers, ultimately benefiting patients across the United States. With its strategic location and state-of-the-art infrastructure, the Cranbury facility is poised to play a critical role in Biocon’s global expansion plans.