Kemwell Announces Successful Pre-NDA US FDA Inspection
RESEARCH TRIANGLE PARK, North Carolina, January 31, 2013 /PRNewswire/ --
KEMWELL BIOPHARMA PVT LTD, a global pharmaceutical contract development and manufacturing company, announced today that its Oral Solids manufacturing facility located in Bangalore, India has successfully completed a U.S. Food and Drug Administration (USFDA) inspection. The cGMP Audit for a Pre-Approval Inspection (PAI) was triggered by a NDA filing by one of the top ten global pharmaceutical companies. This project is part of a growing effort to serve the US market.
"The approval from the US FDA confirms Kemwell's cGMP manufacturing capability and regulatory compliance, and our commitment to provide our customers the highest standards of quality. The facility has been approved by many global regulatory authorities including EMA, MHRA, Health Canada and TGA. We will continue to strive to provide excellent quality pharmaceutical products and deliver on the highest customer service expectations" says Anurag Bagaria, Chairman and Managing Director.
Applying Quality by Design (QbD) principles, Kemwell's R&D and manufacturing teams in conjunction with the customer, optimized tablet formulation, conducted process scale-up studies to define design space for manufacturing of tablet formulation, and manufactured the validation and submission batches for this NDA filing. The audit involved an in-depth review and evaluation of all systems, procedures and processes related to the development, validation and manufacture of oral solids at the Bangalore site.
The state-of-the-art facility started cGMP production in 2008 and is designed to produce 5 billion tablets and capsules annually. The facility has been built in with high flexibility to manage batch sizes from 10kg to 1000kg. Kemwell has been regularly shipping products to Europe and Australia from this facility, and will now soon start commercial supplies to Canada and USA.
Kemwell Biopharma Pvt Ltd headquartered in Bangalore, India is a pure-play global contract development and manufacturing company. The company manufactures pharmaceuticals for some of the world's top pharmaceutical companies, including GlaxoSmithKline, Bayer, Novartis and Pfizer. Kemwell is one of India's largest contract manufacturers of pharmaceuticals with over 30 years' experience. The company employs more than 1000 employees worldwide and has seven production facilities, five in India and two in Sweden. Kemwell is an approved pharmaceutical manufacturer in over 80 countries including the American, European, Japanese and Indian markets.
Read more about Kemwell on http://www.kemwellbiopharma.com
For further queries please contact:
Christian Ahlmark, Dir. Corporate Development
SOURCE Kemwell Biopharma Pvt Ltd