Kemwell Passes FDA InspectionBy
Kemwell Biopharma Pvt. Ltd., a global bio/pharmaceutical contract development and manufacturing company, reports that its oral solids manufacturing facility located in Bangalore, India has successfully completed its second US Food and Drug Administration (US FDA) inspection. This audit took place for an abbreviated new drug application filed for a customer.
On completion of the inspection, the US FDA inspector concluded that the facility, systems, and practices comply with US FDA requirements and no observations were reported on Form 483.
The oral solids facility started cGMP production in 2008 and is designed to produce 5 billion tablets and capsules annually. The facility can produce batch sizes ranging from 10 kg to 1000 kg. Kemwell has been regularly shipping products to Europe, Australia, Canada,and the US from this facility.