Kemwell Biopharma, a global bio/pharmaceutical contract development and manufacturingcompany, announced that its oral solids manufacturing facility located in Bangalore, India has successfully completed its second U.S. Food and Drug Administration inspection.
This audit took place for an ANDA filed for a customer. On completion of the inspection, the FDA inspector concluded that the facility, systems and practices comply with U.S. FDA requirements and no observations were reported on Form 483.
The state-of-the-art oral solids facility started cGMP production in 2008 and is designed to produce 5 billion tablets and capsules annually. The facility has high flexibility built-in to manage batch sizes ranging from 10kg to 1000kg. Kemwell has been regularly shipping products to Europe, Australia, Canada and USA from this facility.
Read the press release