Kemwell Biopharma Pvt. Ltd., a global biopharmaceutical 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 (FDA) inspection. This audit took place for an ANDA filed for a customer.
On completion of the inspection, the FDA inspector concluded that the facility, systems and practices comply with FDA 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 10 kg to 1000 kg. Kemwell has been regularly shipping products to Europe, Australia, Canada and USA from this facility.
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 FDA, EMA, HC and PMDA.
Kemwell services over 100 global bio/ pharmaceutical companies, including seven of the top 10 Big Pharma. Founded in 1980, Kemwell employs 1200 people, has 10 facilities worldwide and supplies to 80 countries globally.