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.
Concept Life Sciences and Alderley Analytical Partner to provide Bioanalytical and DMPK ServicesNews
Companies announced they have signed a partnership agreement to provide high-value bioanalytical and DMPK study services.READ MORE
Concept Life Sciences appoints New Group Programme Manager and US Head of SalesNews
Key leadership appointments support integration of the Group and expansion in the US market.READ MORE