Alembic Pharmaceuticals Limited (APL) has announced a significant development in its regulatory compliance efforts. The company has received an Establishment Inspection Report (EIR) from the United States Food and Drug Administration (US FDA) for its API-I and API-II facilities located in Panelav.

Inspection Details

The US FDA conducted an inspection of APL's Panelav facilities from May 26 to May 31. This thorough examination of the company's Active Pharmaceutical Ingredient (API) manufacturing units is a crucial step in ensuring compliance with US regulatory standards.

Official Notification

APL officially informed the Bombay Stock Exchange (BSE) and the National Stock Exchange of India (NSE) about receiving the EIR on September 13. The company's prompt disclosure aligns with its commitment to transparency and regulatory compliance.

Significance of the EIR

Receiving an Establishment Inspection Report from the US FDA is a notable milestone for pharmaceutical companies. It typically indicates that the FDA has completed its inspection and found the facilities to be in an acceptable state of compliance with current good manufacturing practice (cGMP) regulations.

Impact on Alembic Pharmaceuticals

The successful completion of this inspection and receipt of the EIR could potentially strengthen Alembic Pharmaceuticals' position in the global pharmaceutical market, particularly in the United States. It may enhance the company's credibility and could be viewed positively by stakeholders and potential partners.

Company's Response

Manisha Saraf, Company Secretary of Alembic Pharmaceuticals Limited, signed the official communication to the stock exchanges, underlining the importance of this development for the company.

This latest regulatory milestone comes as part of Alembic Pharmaceuticals' ongoing efforts to maintain high standards of quality and compliance in its manufacturing processes, particularly for its API facilities which play a crucial role in the pharmaceutical supply chain.

Alembic Pharmaceuticals , a prominent player in the pharmaceutical industry, has achieved a significant milestone with the recent approval from the U.S. Food and Drug Administration (USFDA) for its Phytonadione Injectable Emulsion USP. The company anticipates substantial revenue generation from this newly approved product, projecting sales of $44.00 million.

Product Details and Market Potential

The approved Abbreviated New Drug Application (ANDA) is for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe. This product is therapeutically equivalent to the reference listed drug product (RLD) manufactured by International Medication Systems Limited.

According to IQVIA data, the estimated market size for Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL Single-Dose Prefilled Syringe, stands at $44.00 million for the twelve months ending June 2025. This approval opens up a significant market opportunity for Alembic Pharmaceuticals.

Medical Applications

Phytonadione Injectable Emulsion serves crucial medical purposes:

1. Treatment of hypoprothrombinemia due to vitamin K deficiency or interference
2. Prophylaxis and treatment of vitamin K-deficiency bleeding in neonates

Alembic's Growing Portfolio

This latest approval further strengthens Alembic Pharmaceuticals' position in the U.S. market. The company now boasts a cumulative total of 225 ANDA approvals from the USFDA, comprising 204 final approvals and 21 tentative approvals.

Company Background

Alembic Pharmaceuticals Limited, with a rich heritage dating back to 1907, is a vertically integrated research and development pharmaceutical company. Headquartered in India, the company is publicly listed and specializes in manufacturing and marketing generic pharmaceutical products globally.

The company's state-of-the-art research and manufacturing facilities have received approvals from regulatory authorities of many developed countries, including the USFDA. Alembic has established itself as one of the leaders in branded generics in India, with its products marketed through a field force of over 5,500 representatives.

This USFDA approval for Phytonadione Injectable Emulsion USP marks another step forward in Alembic Pharmaceuticals' journey of growth and innovation in the pharmaceutical sector, potentially boosting its market presence and financial performance in the coming years.