Kemwell Biopharma’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 ten global pharmaceutical company.     Kemwell’s R&D and manufacturing teams, along with the customer, optimized tablet formulation, conducted process scale-up studies, and manufactured the validation and submission batches for this NDA filing. The audit involved a review an...