Kemwell Biopharma Pvt Ltd, a global pharmaceutical contract development and manufacturing company, has successfully completed its US Food and Drug Administration (FDA) inspection at its Oral Solids manufacturing facility.
The cGMP audit for a Pre-Approval Inspection (PAI) was triggered by a new drug application (NDA) filing by one of the top ten global pharmaceutical companies. 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 Bengaluru site.
“The approval from the US FDA confirms our 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.
Applying Quality by Design (QbD) principles, the company’s R&D and manufacturing teams in conjunction with the customer, optimized tablet formulation, conducted process scale-up studies to define design space for manufacturing of tablet formulation, and manufactured the validation and submission batches for this NDA filing, he added.
The state-of-the-art facility started cGMP production in 2008 and is designed to produce five billion tablets and capsules annually. The facility has been built in with high flexibility to manage batch sizes from 10 kg to 1000 kg. Kemwell has been regularly shipping products to Europe and Australia from this facility, and will now soon start commercial supplies to Canada and USA.
Kemwell Biopharma is a pure-play global contract development and manufacturing company. The company manufactures for leading pharmaceutical companies, including GlaxoSmithKline, Bayer, Johnson & Johnson, Novartis and Pfizer.