The US FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021
Granules India Limited has announced that Granules Pharmaceuticals, Inc. (GPI), a wholly owned foreign subsidiary of the company located in Chantilly, Virginia, USA has got US FDA approval for three of its applications filed from the facility.
The company had undergone a Pre-Approval Inspection (PAI) audit by the U.S. Food and Drug Administration (FDA) from 21st June 2021 to 25th June 2021.
The audit is a pre-approval inspection for three of its applications filed from this facility. The FDA issued two minor observations during the audit.
“The observations were responded to within the stipulated time, and we are happy to inform you that the FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021. This is the fifth US FDA audit for this facility,” said Priyanka Chigurupati, Executive Director, GPI.
Granules India is a growing pharmaceutical manufacturing company with best-in-class facilities and is committed to operational excellence, quality and customer service. The company produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice. The company has seven manufacturing facilities out of which six are located in India and one in the USA.
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