US FDA audit at Hikal’s Panoli facility concludes with zero observations

Hikal’s pharma manufacturing facility located at Panoli, Gujarat, was recently inspected by the US Food and Drug Administration (US FDA) in compliance with their requirements. The five-day preapproval inspection of an API was conducted from May 8-12, 2023 was concluded with ‘Zero 483 observations’ from the US FDA.

The Panoli facility was earlier audited twice by the US FDA and successfully approved for manufacturing advanced intermediates and key starting materials.