Granules India Limited Announcement

Hyderabad: Granules India Limited has announced that the US Food & Drug Administration (US FDA) has approved its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-Release Tablets USP, 20 mg and 40 mg.

It is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Protonix Delayed-Release Tablets, 20 mg and 40 mg, of Wyeth Pharmaceuticals LLC.

Pantoprazole Sodium Delayed-Release Tablets are indicated for:

• Short-term Treatment of Erosive Esophagitis Associated with Gastroesophageal Reflux Disease (GERD)
• Maintenance of Healing of Erosive Esophagitis
• Pathological Hypersecretory Conditions Including Zollinger-Ellison (ZE) Syndrome

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.

The 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.

Read also: Granules India bags USFDA nod for Esomeprazole Magnesium Delayed-Release Capsules for GERD symptoms

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 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+ 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 the 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 subsidiary bags USFDA nod for Sildenafil for Oral Suspension