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Biocon's new US facility clears key FDA hurdle, to strengthen footprint

The New Indian Express Tirupati

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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).

- ENS ECONOMIC BUREAU @NewDelhi

Biocon's new US facility clears key FDA hurdle, to strengthen footprint

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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