Biocon gets 1 USFDA observation for Cranbury site
Bangalore: Biocon has announced that its manufacturing site in Cranbury, New Jersey, has received a single observation following a GMP inspection by the U.S. Food and Drug Administration (USFDA).
This inspection took place after the inauguration of the Company’s first manufacturing site in Cranbury in September by its wholly owned subsidiary, Biocon Generics Inc (BGI).
Read also: Biocon Opens First US Manufacturing Facility in New Jersey, Invests USD 30 Million in Expansion
"This is to inform that subsequent to the inauguration of the Company’s first manufacturing site in the United States, located in Cranbury, New Jersey, in September, that will support capacity expansion and supply chain efficiency in the region, the facility underwent a GMP inspection by the U.S. FDA," Biocon stated in a BSE filing.
Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc. in 2023 and has since invested over USD 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.
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