Granules arm gets U.S. FDA observation resolved
Generic drugmaker Granules India on Saturday said subsidiary Granules Pharmaceuticals Inc. addressed and resolved a U.S. Food and Drug Administration observation during the same inspection when it was issued by the regulator.
The U.S. FDA had completed a pre-approval inspection (PAI) for a first to file controlled substance ANDA (abbreviated new drug application) at the facility of Granules Pharmaceuticals Inc. in Chantilly, Virginia, USA from June 23-27 with one Form 483 observation.
The subsidiary 'addressed and resolved the observation during the inspection,' the Hyderabad-headquartered parent company said in a filing.
Last week the U.S. FDA had issued an observation to Granules India's active pharmaceutical ingredients (API) manufacturing facility in Bonthapally, Hyderabad, which is one of the world's largest single-site paracetamol API manufacturing plants by volume.
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