The pre-approval inspection was triggered when the plant in Bangalore was included in an new drug application (NDA) filed with the US regulator by one of the contract manufacturing organisation’s (CMO) customers.
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 facility – which has been producing around 5 billion tablets a year since opening in 2005 – already supplies pharmaceutical industry customers in Europe and Australia. Kemwell said that it expects to start shipping to customers in the US and Canada in the near future.
Anurag Bagaria, Kemwell Chairman and Managing Director, said the US FDA approval “confirms Kemwell’s cGMP manufacturing capability and regulatory compliance” adding that “we will continue to strive to provide excellent quality pharmaceutical products and deliver on the highest customer service expectations.”