Last updated on April 19, 2014 at 13:20 EDT

Kemwell Announces Successful Pre-NDA US FDA Inspection

January 31, 2013

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

Source: PR Newswire