Granules India receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules, ET HealthWorld

by Rahul Devi

Granules India Limited has received approval from the US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20mg and 40mg. These capsules are bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Nexium Delayed-Release Capsules, 20mg and 40mg, of AstraZeneca Pharmaceuticals LP.

Esomeprazole Magnesium capsules are used for the short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD), risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcers in adults at risk for developing gastric ulcers, helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin, and long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

This approval marks another milestone for Granules India Limited, as it now has a total of 62 ANDA approvals from the US FDA, including 60 final approvals and two tentative approvals. The current annual US market for Esomeprazole Magnesium Delayed-Release Capsules is approximately $168 million, according to MAT July 2023, IQVIA/IMS Health.

This latest approval reinforces Granules India Limited’s commitment to providing high-quality generic pharmaceutical products to patients in the US market. With its extensive portfolio of ANDA approvals, the company continues to play a significant role in the healthcare industry.

Granules India Limited’s success in obtaining FDA approvals showcases its dedication to regulatory compliance and its ability to meet the stringent standards set by the US FDA. This achievement not only strengthens the company’s position in the market but also reflects its commitment to meeting the needs of patients and healthcare professionals.

As the demand for generic pharmaceutical products continues to rise, Granules India Limited remains at the forefront of innovation and growth in the industry. With its focus on research and development, manufacturing excellence, and regulatory compliance, the company is well-positioned to capitalize on the opportunities in the global pharmaceutical market.

In conclusion, Granules India Limited’s recent approval from the US FDA for its Esomeprazole Magnesium Delayed-Release Capsules is a testament to its commitment to quality and patient care. With its expanding portfolio of generic pharmaceutical products, the company is poised for continued success in the US market and beyond.

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