USFDA Approval: For Pantoprazole Sodium DR Tablets

This recent USFDA approval adds to Granules India's impressive portfolio of ANDA approvals.

USFDA Drug product Approval
USFDA Approval

USFDA Approval

Granules India, a prominent player in the pharmaceutical arena, recently received a groundbreaking announcement – the US Food & Drug Administration (USFDA) has granted USFDA approval for its Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium Delayed-Release Tablets USP, in both 20 mg and 40 mg formulations.

This USFD Aapproval marks a significant milestone for Granu les India, as these tablets are deemed bioequivalent and therapeutically equivalent to the reference listed drug, Protonix Delayed-Release Tablets, 20 mg and 40 mg, of Wyeth Pharmaceuticals.

Understanding Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium Delayed-Release Tablets serve a crucial purpose in the medical landscape.

They are primarily indicated for the short-term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD), the maintenance of healing of erosive esophagitis, and the management of pathological hypersecretory conditions, including Zollinger-Ellison (ZE) Syndrome.

The bioequivalence and therapeutic equivalence to the reference listed drug underscore the reliability and effectiveness of Granules India’s formulation.

Scope of Application

The scope of application for these tablets extends to addressing various conditions, making them a versatile option for healthcare professionals.

From tackling erosive esophagitis to managing GERD and Zollinger-Ellison Syndrome, these tablets provide a comprehensive solution to diverse medical needs.

USFDA Approval Process

The USFDA approval by the USFDA is no small feat. The rigorous process of obtaining an Abbreviated New Drug Application involves comprehensive testing and scrutiny.

Granules India’s success in navigating this process reflects its commitment to quality and adherence to regulatory standards, ensuring that their pharmaceutical products meet the highest benchmarks of safety and efficacy.

Market Impact

In a pharmaceutical landscape driven by innovation and competition, the USFDA approval of Pantoprazole Sodium Delayed-Release Tablets opens up new avenues for Granules India.

The current annual US market for Pantoprazole Tablets, estimated at approximately $233 million, according to IQVIA/IMS Health, MAT Oct 2023, positions Granules India strategically in a lucrative market.

Granules India’s Achievements

This recent USFDA approval adds to Granules India’s impressive portfolio of ANDA approvals.

With a total of 64 ANDA approvals from the USFDA, comprising 62 final approvals and two tentative approvals, Granules India continues to solidify its position as a key player in the pharmaceutical industry.

Significance of Bioequivalence

The concept of bioequivalence holds paramount importance in the pharmaceutical realm.

It ensures that generic formulations are as effective and safe as the original branded products.

Granules India’s commitment to achieving bioequivalence underscores its dedication to delivering high-quality pharmaceuticals that prioritize patient safety and efficacy.

Patient Considerations

For potential users of Pantoprazole Sodium Delayed-Release Tablets, understanding the medication is crucial.

This section addresses common concerns, providing information on usage, potential side effects, and other considerations to ensure that patients are well-informed about the medication they are prescribed.

Challenges and Opportunities

While the USFDA approval is a significant achievement, Granules India may face challenges in a competitive market.

However, with challenges come opportunities for growth and expansion. Navigating potential obstacles and capitalizing on opportunities will be crucial for the company’s continued success.

Expert Opinions

Industry experts play a vital role in providing insights into the significance of USFDA approvals. Their perspectives shed light on the implications of this approval for Granules India and the pharmaceutical industry at large.

Future Prospects

As Granules India celebrates this achievement, the future holds exciting prospects.

Predictions for the company’s trajectory in the pharmaceutical market and potential developments in research and innovation pave the way for continued success.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.


  1. Is Pantoprazole Sodium Delayed-Release Tablets suitable for long-term use?
    • Our article addresses the indications and considerations for the duration of use.
  2. How does Granules India ensure the quality of its pharmaceutical products?
    • Granules India’s success in FDA approvals reflects its commitment to quality and adherence to regulatory standards.
  3. What sets Pantoprazole Sodium Delayed-Release Tablets apart from other similar medications?
    • The article highlights the bioequivalence and therapeutic equivalence of Granules India’s formulation.
  4. What challenges might Granules India face in the competitive market?
    • The challenges and opportunities section delves into potential obstacles and growth prospects for Granules India.
  5. Are there any side effects associated with Pantoprazole Sodium Delayed-Release Tablets?
    • Patient considerations address potential side effects and provide information for potential users.

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