Alembic Pharmaceuticals Receives FDA Approval for Generic Tretinoin Cream to Treat Acne Vulgaris

Key Insights

• Alembic Pharmaceuticals has received final FDA approval for its generic Tretinoin Cream USP (0.025%) to treat acne vulgaris in the US market.
• The approved generic is therapeutically equivalent to Bausch Health's reference drug Retin-A Cream, targeting a market estimated at $94 million annually.
• This approval brings Alembic's total ANDA portfolio to 224 applications, with 202 final approvals and 22 tentative approvals from the FDA.

Alembic Pharmaceuticals announced it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP (0.025%), a generic medication for treating acne vulgaris. The approval positions the Indian pharmaceutical company to compete in a significant US dermatology market segment.

Market Opportunity and Therapeutic Equivalence

The approved ANDA is therapeutically equivalent to the reference listed drug product Retin-A Cream, 0.025%, manufactured by Bausch Health US, LLC. According to market research firm IQVIA, Tretinoin cream USP, 0.025%, represents an estimated market size of $94 million for the twelve months ending June 2025.

Tretinoin cream is indicated for topical application in the treatment of acne vulgaris, a common skin condition affecting millions of patients. The generic approval provides healthcare providers and patients with an additional treatment option in this therapeutic category.

Expanding ANDA Portfolio

With this latest approval, Alembic's cumulative tally of ANDAs now stands at 224 applications. The company's regulatory track record includes 202 final approvals and 22 tentative approvals from the FDA, demonstrating its consistent ability to meet US regulatory standards.

Company Profile and Market Position

Founded in 1907, Alembic ranks among India's oldest pharmaceutical companies and has evolved into a fully integrated player with research-driven operations. The company's manufacturing facilities have received clearance from global regulators, including the USFDA, supporting its international expansion strategy.

Beyond its international generics business, Alembic maintains a strong position in India's branded generics market, supported by a field force of more than 5,500 professionals. The company's products are widely prescribed and recognized across multiple therapeutic categories.

Following the announcement, Alembic Pharmaceuticals shares traded 1.03% higher at ₹968.10 on the BSE, reflecting investor confidence in the company's regulatory achievements and market expansion potential.