Granules India bags USFDA nod for Pantoprazole Sodium Delayed Release Tablets

Granules now has a total of 64 ANDA approvals from the US FDA (62 final approvals and 2 tentative approvals). The current annual U.S. market for Pantoprazole Tablets is approximately $233 million, according to IQVIA/IMS Health, MAT Oct 2023.

Medical Dialogues team had earlier reported that the USFDA had approved Granules India's Abbreviated New Drug Application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg.

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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.