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Kemwell Announces Successful Pre-NDA US FDA Inspection

Published: Friday, February 01, 2013
Last Updated: Friday, February 01, 2013
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The cGMP Audit for a Pre-Approval Inspection (PAI) was triggered by an NDA filing by one of the top ten global pharmaceutical companies.

Kemwell has manufactured numerous products for the European markets for top pharmaceutical companies. This project is part of a growing effort to serve the US market.

"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," says Anurag Bagaria , Chairman and Managing Director, Kemwell Biopharma.

Applying Quality by Design (QbD) principles, Kemwell'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. 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 Bangalore site.

The state-of-the-art facility started cGMP production in 2008 and is designed to produce 5 billion tablets and capsules annually. The facility has been built-in with high flexibility to manage batch sizes from 10kg to 1000kg. Kemwell has been regularly shipping products to Europe and Australia from this facility, and will now soon start commercial supplies to Canada and USA.


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