Kemwell’s oral solids manufacturing facility in Bangalore, India has successfully completed a U.S. FDA inspection. The cGMP audit for a Pre-Approval Inspection (PAI) was triggered by a NDA filing by a top 10 global pharmaceutical company. The audit involved an in-depth review and evaluation of all systems, procedures and processes related to the development, validation and manufacture of oral solids at the site.   Anurag Bagaria, Kemwell’s chairman and managing director, remarked, “The approval ...