Tuesday, March 24, 2015 Daily Archives

Kemwell Announces Successful U.S. FDA Inspection of its Bangalore, India Manufacturing Facility

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…