Granules Pharma clears USFDA Audit
Ms. Priyanka Chigurupati, Executive Director, GPI, said "We are glad to have completed yet another audit after successfully addressing minor observations. This is the sixth successful USFDA audit for this facility."
Hyderabad: Granules India Limited, announced that Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, located in Chantilly, Virginia, USA received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA).
The GPI facility was inspected by the US FDA from 24th to 28th January 2022 for two of its product applications filed. There were three minor observations during the inspection and GPI had addressed the observations in the stipulated time period.
Commenting on the audit Ms. Priyanka Chigurupati, Executive Director, GPI, said "We are glad to have completed yet another audit after successfully addressing minor observations. This is the sixth successful US FDA audit for this facility."
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Granules India Limited, incorporated in 1991 is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad with best-in-class facilities and commitment to operational excellence, quality, and customer service. We are among the few pharmaceutical companies in the world to be present in the manufacturing of the entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs), and Finished Dosages (FDs). Our products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 75+ 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 the 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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