US FDA completes inspection of Granules India's facility

The paracetamol facility of the Hyderabad-based Granules India Ltd has successfully passed a US FDA inspection without any 483 observations. The facility has the world’s largest single active pharmaceutical ingredient (API) production line by volume.
 
Granules’ four API facilities have successfully passed US FDA inspections in the past 12 months. All of Granules’ facilities including its finished dosage and PFI facility are approved by leading regulatory agencies including the US FDA, EDQM, Health Canada and Korean FDA.