Alembic Pharmaceuticals has achieved a significant milestone in its pharmaceutical portfolio expansion. The company announced on April 1, 2025, that it has received final approval from the United States Food and Drug Administration (USFDA) for its Pantoprazole Sodium for Injection, 40 mg/vial in single-dose vials.

Product Details and Market Potential

The approved Abbreviated New Drug Application (ANDA) for Pantoprazole Sodium for Injection is therapeutically equivalent to the reference listed drug product, Protonix I.V. for Injection, 40 mg/vial, manufactured by Wyeth Pharmaceuticals LLC. This injection is primarily indicated for:

• Treatment of gastroesophageal reflux disease (GERD) in adults for up to 10 days
• Treatment of adults with a history of erosive esophagitis (EE)
• Treatment of pathological hypersecretion conditions, including Zollinger-Ellison (ZE) Syndrome in adults

According to IQVIA data, the estimated market size for Pantoprazole Sodium for Injection, 40 mg/vial (Single-Dose Vial) is approximately $48.00 million for the twelve months ending December 2024.

Alembic's Growing ANDA Portfolio

With this latest approval, Alembic Pharmaceuticals has further strengthened its position in the U.S. generic pharmaceutical market. The company now boasts a cumulative total of 221 ANDA approvals from the USFDA:

This extensive portfolio demonstrates Alembic's commitment to expanding its presence in the highly competitive U.S. pharmaceutical market.

Company Overview

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been a prominent player in the healthcare sector since 1907. Headquartered in India, the company is publicly listed and specializes in manufacturing and marketing generic pharmaceutical products globally.

Key Features:

• State-of-the-art research and manufacturing facilities
• Approvals from regulatory authorities of many developed countries, including the USFDA
• Leader in branded generics in India
• Field force of over 5,200 representatives
• Well-recognized brands among doctors and patients

This latest USFDA approval for Pantoprazole Sodium for Injection marks another important step in Alembic's growth strategy, further cementing its position as a key player in the global pharmaceutical industry.

Alembic Pharmaceuticals Limited (Alembic Pharma) has achieved a significant milestone in its quality assurance efforts. The company's Active Pharmaceutical Ingredient (API) manufacturing facility, API-III, located in Karakhadi, has successfully passed a rigorous inspection by the United States Food and Drug Administration (USFDA).

Inspection Outcome

The scheduled Good Manufacturing Practice (GMP) inspection conducted by the USFDA concluded on a highly positive note. Notably, the inspection was completed without any Form 483 observations, which is a testament to the facility's adherence to high-quality standards and regulatory compliance.

Significance of No Form 483 Observations

The absence of Form 483 observations is particularly noteworthy in the pharmaceutical industry. When the FDA conducts an inspection and finds no significant objectionable conditions or practices, it does not issue a Form 483. This outcome indicates that:

• The facility maintains excellent manufacturing practices
• Quality control processes are robust and effective
• The company's operations align well with FDA regulations

Implications for Alembic Pharmaceuticals

This successful inspection outcome has several positive implications for Alembic Pharmaceuticals:

1. Regulatory Compliance: It reinforces the company's commitment to maintaining high standards of quality and regulatory compliance.

2. Market Confidence: A clean FDA inspection can boost confidence among stakeholders, including customers, partners, and investors.

3. Operational Continuity: The successful inspection ensures that the API-III facility can continue its operations without any regulatory hurdles, potentially supporting uninterrupted supply chains.

4. Competitive Advantage: In the highly regulated pharmaceutical industry, such achievements can provide a competitive edge and potentially open doors to new business opportunities.

About the Facility

The API-III facility in Karakhadi is one of Alembic Pharmaceuticals' key manufacturing units. It specializes in the production of Active Pharmaceutical Ingredients, which are crucial components in the manufacture of various drugs.

Conclusion

This successful USFDA inspection underscores Alembic Pharmaceuticals' ongoing commitment to quality and regulatory excellence in its manufacturing processes. As the pharmaceutical landscape continues to evolve with increasing regulatory scrutiny, such achievements play a vital role in maintaining the company's standing in the global pharmaceutical market.