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Biocon's new US facility clears key FDA hurdle, to strengthen footprint
The New Indian Express Shivamogga
|October 13, 2025
BIOCON Ltd has announced that its first manufacturing facility in the US, in Cranbury, New Jersey, has 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 US 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.
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