USFDA successfully concludes inspection at Granules India Jeedimetla facility

Published On 2023-06-24 07:00 GMT   |   Update On 2023-06-24 07:00 GMT
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Hyderabad: Granules India has recently announced that Company’s Jeedimetla facility located at Hyderabad, Telangana, India has successfully completed the US FDA’s surveillance inspection with zero (0) 483 observations.

The inspection was held from 19th June 2023 to 23rd June 2023.

Jeedimetla facility manufactures Active Pharmaceutical Ingredients (API) and Pharmaceutical Formulation Intermediates (PFIs).

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Read also: USFDA nod to Granules India Seizure drug Levetiracetam

Granules India Limited, incorporated in 1991 is a vertically integrated fast-growing Indian pharmaceutical company headquartered in Hyderabad. The Company is 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). Its products are being distributed to over 300 plus customers in regulated and semi-regulated markets with a global presence extending to over 80 plus 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.

Read also: Granules India bags USFDA nod for Hypertension drug Metoprolol Succinate ER


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