News

Article

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-04-01-2015
Volume11
Issue 4

Kemwell’s Bangalore Facility Completes Successful FDA Inspection

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.

Source: Kemwell

Newsletter

Get the essential updates shaping the future of pharma manufacturing and compliance—subscribe today to Pharmaceutical Technology and never miss a breakthrough.

Related Videos
A global supply chain map, visualizing the complex network of transportation routes and distribution centers | Image Credit: © venusvi - stock.adobe.com
Shortcut from point A to point B | Image Credit: © Olivier Le Moal - stock.adobe.com
Behind the Headlines, Episode 21: Waters-BD Merger, Merck’s $10B Bet, and Biotech’s Investment Frontiers
Wooden blocks spelling TARIFFS are placed on a map of North America, specifically over the United States and Mexico | Image Credit: © Rokas - stock.adobe.com
Jason Waite, International Trade Expert, Alston & Bird
Simona Guidi, Associate Director, ProPharma
Tore Bergsteiner
Behind the Headlines, Episode 20: CAR-T Milestones, Abbvie and Eli Lilly M&A Moves, and More
Related Content