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.

Alembic Pharmaceuticals has achieved a significant milestone in its product portfolio expansion. The company announced that it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tretinoin Cream USP, 0.025%.

Product Details and Market Potential

The approved Tretinoin Cream is therapeutically equivalent to Bausch Health US, LLC's Retin-A Cream, which serves as the reference listed drug product (RLD). This topical treatment is indicated for acne vulgaris, a common skin condition affecting millions worldwide.

According to IQVIA data, the Tretinoin cream market has an estimated size of US$ 94.00 million for the twelve months ending June, highlighting the potential commercial value of this approval for Alembic Pharmaceuticals.

Expanding Product Portfolio

This latest approval further strengthens Alembic's position in the generic pharmaceutical market. With this addition, the company now boasts a cumulative total of 224 ANDA approvals from the USFDA, comprising:

• 202 final approvals
• 22 tentative approvals

Company Profile

Alembic Pharmaceuticals, established in 1907, is a vertically integrated research and development pharmaceutical company. The firm has a strong presence in both domestic and international markets:

• Manufactures and markets generic pharmaceutical products globally
• One of the leaders in branded generics in India
• Employs a field force of over 5,500 for marketing its brands
• Operates state-of-the-art research and manufacturing facilities approved by regulatory authorities of many developed countries, including the USFDA

This USFDA approval for Tretinoin Cream represents another step forward in Alembic Pharmaceuticals' ongoing efforts to expand its product offerings and strengthen its position in the global generic pharmaceutical market.