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 and evaluation of all systems, procedures and processes related to the development, validation and manufacture of oral solids at the site.
"The approval from the US FDA 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," said Anurag Bagaria, chairman and managing director.