Alembic Pharmaceuticals has achieved a significant regulatory milestone with the receipt of USFDA final approval for Difluprednate Ophthalmic Emulsion, 0.05%. This approval marks another important step in the company's expansion within the US pharmaceutical market.

Product Details and Market Significance

The approved product serves as a generic equivalent to Durezol Ophthalmic Emulsion, expanding Alembic Pharmaceuticals' presence in the ophthalmic therapeutics segment. Difluprednate is a topical corticosteroid used for treating inflammation and pain associated with ocular surgery.

Regulatory Achievement

This latest USFDA approval brings Alembic Pharmaceuticals' total count of Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration to 233. This milestone demonstrates the company's consistent regulatory compliance and successful navigation of the complex USFDA approval process.

Strategic Impact

The approval strengthens Alembic Pharmaceuticals' generic drug portfolio in the United States market. With 233 ANDA approvals now in its portfolio, the company continues to build its presence across various therapeutic segments, including the specialized ophthalmic market segment.

Alembic Pharmaceuticals Limited has received tentative approval from the US Food and Drug Administration (USFDA) for its Bosutinib Tablets, 400 mg, marking another significant milestone in the company's US generics portfolio. The approval was announced on Monday, January 12, through a regulatory filing.

Regulatory Approval Details

The tentative approval has been granted for the company's supplemental Abbreviated New Drug Application (sANDA). The product demonstrates therapeutic equivalence to Bosulif Tablets, 400 mg, which is currently marketed by PF Prism C.V. This approval adds to Alembic's existing USFDA approvals for Bosutinib Tablets in 100 mg and 500 mg strengths, representing an additional opportunity in the molecule's lifecycle.

Drug Profile and Market Potential

Bosutinib is a kinase inhibitor specifically designed for treating adult patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML). The drug serves multiple patient populations:

• Newly-diagnosed CML patients
• Patients resistant or intolerant to prior therapies
• Adult patients with accelerated or blast phase Ph+ CML showing resistance or intolerance to earlier treatments

According to IQVIA data cited by the company, Bosutinib Tablets, 400 mg, represents a substantial market opportunity:

USFDA Approval Portfolio

With this latest tentative approval, Alembic Pharmaceuticals has strengthened its regulatory standing with the USFDA. The company's cumulative ANDA approvals now total 232, demonstrating its robust pipeline and regulatory capabilities.

This milestone underlines Alembic's continued focus on the US generics market and its ability to navigate complex regulatory processes successfully.

Recent Financial Performance

Alembic Pharmaceuticals reported strong financial results in its recent quarter, showcasing robust growth across key metrics:

The company's operating margins expanded significantly to 16.50% from 14.50% in the previous year, reflecting improved operational efficiency and strong business fundamentals.

Company Overview

Alembic Pharmaceuticals operates as a vertically integrated pharmaceutical company with comprehensive capabilities spanning research, development, manufacturing, and marketing of generic medicines across key global markets. The company recently received final USFDA approval in November for Diltiazem Hydrochloride Tablets USP in multiple strengths (30 mg, 60 mg, 90 mg, and 120 mg), further expanding its approved product portfolio.