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 confirms Kemwell’s cGMP manufacturing capability and regulatory compliance, and our commitment to provide our customers the highest standards of quality. The facility has been approved by many global regulatory authorities, including EMA, MHRA, Health Canada and TGA. We will continue to strive to provide excellent quality pharmaceutical products and deliver on the highest customer service expectations.”
Kemwell’s R&D and manufacturing teams in conjunction with the customer, optimized tablet formulation, conducted process scale-up studies, and manufactured the validation and submission batches for the NDA filing. The facility began cGMP production in 2008 and is designed to produce five billion tablets and capsules annually.