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Kemwell announces successful
USFDA inspection
PRESS RELEASE
Bangalore, India - 23rd March, 2015
Kemwell Biopharma Pvt. Ltd., a global bio/pharmaceutical contract development and manufacturing
company, announced today that its oral solids manufacturing facility located in Bangalore, India has
successfully completed its second U.S. Food and Drug Administration (USFDA) inspection. This audit took
place for an ANDA filed for a customer.
On completion of the inspection, the USFDA inspector concluded that the facility, systems and practices
comply with USFDA requirements and no observations were reported on Form 483.
“Kemwell’s team is proud of the results of the FDA inspection. This success is testament to our ongoing
commitment towards our quality systems. We continue to leverage our 30-year experience in being a leading
CDMO to provide our customers with cost-effective solutions at high quality standards.” says Anurag Bagaria,
Chairman and Managing Director.
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.
About Kemwell:
Kemwell Biopharma is a 100% CDMO that provides customized product development and cGMP compliant
manufacturing solutions to pharmaceutical and biopharmaceutical organizations worldwide. With integrated facilities in
India, US and Sweden, Kemwell delivers a comprehensive portfolio of services for sterile and non-sterile products from
preformulation to commercial supply. Kemwell facilities are approved by USFDA, EMA, HC and PMDA.
Kemwell services over 100 global bio/ pharmaceutical companies, including 7 of the top 10 Big Pharma. Founded in
1980, Kemwell employs 1200 people, has 10 facilities worldwide and supplies to 80 countries globally.
Read more about the Kemwell group at www.kemwellbiopharma.com
For further queries please contact:
Karan Bagaria, VP Corporate Development
karan.bagaria@kemwellpharma.com or +91-80-39285450