Granules India secures ANDA approval for Pantoprazole Sodium Tablets from FDA

Granules India Limited, a prominent player in the pharmaceutical industry, 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. This approval is a significant milestone for the company, marking its 64th ANDA approval from the US FDA.

The Therapeutic Importance of Pantoprazole Sodium Tablets:

Pantoprazole Sodium Delayed-Release Tablets are designed to be bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Protonix Delayed-Release Tablets, of Wyeth Pharmaceuticals LLC. These tablets are prescribed for the short-term treatment of Erosive Esophagitis associated with Gastroesophageal Reflux Disease (GERD), Maintenance of Healing of Erosive Esophagitis, and Pathological Hypersecretory Conditions, including Zollinger-Ellison (ZE) Syndrome.

Granules India’s Expanding Portfolio and Market Impact:

With a total of 64 ANDA approvals (62 final and 2 tentative), Granules India Limited continues to strengthen its position in the global pharmaceutical market. The current annual U.S. market for Pantoprazole Tablets is approximately $233 million, according to IQVIA/IMS Health, MAT Oct 2023. This approval places Granules India in a favorable position to cater to a significant segment of the market.

Granules India’s Commitment to Innovative Healthcare Solutions:

The approval of Pantoprazole Sodium Delayed-Release Tablets aligns with Granules India’s commitment to providing innovative and effective healthcare solutions. The company’s continuous efforts in research and development in the pharmaceutical sector are geared towards addressing the evolving healthcare needs of patients worldwide.