Biocon gets 1 USFDA observation for Cranbury site
Drug Approval

Biocon gets 1 USFDA observation for Cranbury site

The Cranbury facility represents a strategic advancement of the company's operations in the Unted States

  • By IPP Bureau | October 14, 2025

Biocon's manufacturing facility in Cranbury, New Jersey, has successfully completed a Good Manufacturing Practices (GMP) inspection by the US Food and Drug Administration (USFDA).

The inspection resulted in one observation, which Biocon intends to address within the required timeframe. The company stated that it does not expect this to impact its business operations at the site.

The Cranbury facility represents a strategic advancement of the company's operations in the Unted States, enabling faster access to Biocon's vertically integrated portfolio of products, benefitting patients in the region.

With some products having already been commissioned from this site and additional launches in the pipeline, the facility will play a key role in furthering Biocon's mission to expand access to high-quality, affordable therapies worldwide.

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