PTSM: Pharmaceutical Technology Sourcing and Management
PTSM: Pharmaceutical Technology Sourcing and Management-04-01-2015, Volume 11, Issue 4
FDA has concluded that Kemwell’s facility, systems, and practices comply with FDA’s requirements and no observations were reported on Form 483.
CDMO, Kemwell, announced that its oral solid dosage manufacturing facility in Bangalore, India has successfully completed a second FDA inspection. The facility was audited following an abbreviated new drug application (ANDA) filing for a customer. The FDA inspector has concluded that Kemwell’s facility, systems, and practices comply with FDA’s requirements and no observations were reported on Form 483.
Production in the state-of-the-art oral solid dosage facility commenced in 2008. The facility, which is equipped to manage batch sizes ranging from 10–1000 kg, manufactures five billion tablets and capsules annually according to Kemwell. The company has been shipping products from this facility to Europe, US, Canada, and Australia.
