Kemwell Announces Successful FDA Inspection

Kemwell Biopharma has announced that its oral solids manufacturing facility located in Bangalore, India has successfully completed its second US Food and Drug Administration (FDA) inspection.

The audit took place for an abbreviated new drug application (ANDA) filed for a customer.

On completion of the inspection, the FDA inspector concluded the facility, systems and practices comply with FDA requirements and no observations were reported on Form 483.

Kemwell chairman Anurag Bagaria said: "Kemwell’s team is proud of the results of the FDA inspection.

"This success is testament to our ongoing commitment towards our quality systems. We continue to leverage our 30-year experience in being a leading CDMO to provide our customers with cost-effective solutions at high-quality standards."

The state-of-the-art oral solids facility started cGMP production in 2008 and is designed to produce five billion tablets and capsules annually.

The facility has high flexibility built in to manage batch sizes ranging from 10kg to 1,000kg. Kemwell ships products to Europe, Australia, Canada and the US from this facility.

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