Biocon gets 1 USFDA observation for Cranbury site

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2025-10-13 05:30 GMT | Update On 2025-10-13 05:30 GMT

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).

"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.

"The inspection concluded with 1 observation which the Company will address within the stipulated time and is not expected to have any impact on business operations," the company added.

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.

Biocon Limited, publicly listed in 2004, is a global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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Biocon gets 1 USFDA observation for Cranbury site

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