Kemwell Announces Successful USFDA Inspection
News Mar 27, 2015
Kemwell Biopharma Pvt. Ltd. has announced 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 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.
Many life-saving medicines, including insulin, antibodies and vaccines, are derived from living cells. These “biologics” can be difficult to obtain and store on the battlefield or in remote areas. That’s why scientists are trying to develop portable systems that can quickly manufacture small batches of protein therapeutics on demand.READ MORE
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