USFDA classifies Granules Pharma facility as Voluntary Action Indicated

Hyderabad: Granules India has informed in a BSE filing that the United States Food and Drug Administration (USFDA) has classified the facility of Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA as “Voluntary Action Indicated” (VAI).

The VAI inspection classification indicates that the US FDA will not take or recommend regulatory or enforcement action because the observations do not meet the threshold for action at this time.

Medical Dialogues team had earlier reported that USFDA had concluded a GMP inspection with five observations at the facility of Granules Pharmaceuticals, Inc., a wholly-owned foreign subsidiary of the Company located in Chantilly, Virginia, USA.

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Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered in Hyderabad. The Company is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, U.S. and U.K. The Company has 7 manufacturing facilities out of which 6 are located in India and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.

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