Granules India Ltd. announced its Paracetamol facility in Andhra Pradesh has successfully passed a U.S. FDA inspection with no 483 observations.
The analgesic facility has the world's largest single API production line by volume, according to the company. In the past 12 months, Granules' four API facilities have successfully passed FDA inspection. All of Granules’ facilities -- including its finished dosage and PFI facility -- are now approved by leading regulatory agencies including the FDA, EDQM, Health Canada and Korean FDA.
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