Granules India Ltd, a fast growing pharmaceutical manufacturing company, announced its paracetamol facility successfully passed a US FDA inspection without any 483 observations. The facility has the world’s largest single 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.