Alembic Pharmaceuticals gets USFDA nod for Tretinoin Cream

Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (USFDA) for Tretinoin Cream USP, 0.05%, expanding its dermatology portfolio in the US generics market. The approval covers the Abbreviated New Drug Application (ANDA) for the product, which is therapeutically equivalent to the reference listed drug Retin-A Cream, 0.05%, marketed by Bausch Health US, LLC. The estimated market size for Tretinoin Cream USP, 0.05% is $76 million for the twelve months ending March 2026, according to IQVIA data.

Regulatory and Product Details

The USFDA final approval allows Alembic to market Tretinoin Cream USP, 0.05% for topical application in the treatment of acne vulgaris. The approval strengthens the company's presence in the US market, which is a key geography for its generic business.

Parameter	Details
Approved Product	Tretinoin Cream USP, 0.05%
Reference Listed Drug	Retin-A Cream, 0.05%
RLD Marketer	Bausch Health US, LLC
Approval Type	Final Approval (ANDA)
Therapeutic Indication	Acne vulgaris
Estimated Market Size	$76 million
Market Data Period	Twelve months ending March 2026

Strategic Context

With this approval, Alembic Pharmaceuticals now holds a cumulative total of 242 ANDA approvals from the USFDA, comprising 222 final approvals and 20 tentative approvals. This milestone underscores the company's consistent execution in its US generics pipeline and its capability to complex product development.

1 Day	5 Days	1 Month	6 Months	1 Year	5 Years
+1.18%	+0.79%	-5.81%	-16.02%	-25.39%	-26.11%

Alembic Pharmaceuticals has received tentative approval from the United States Food and Drug Administration (USFDA) for Larotrectinib Capsules, 25 mg and 100 mg. This regulatory clearance positions the company as the sole first applicant for the product, potentially granting it 180 days of marketing exclusivity in the US upon final approval. The approval covers the Abbreviated New Drug Application (ANDA) for the generic version of Bayer Healthcare Pharmaceuticals Inc.'s Vitrakvi Capsules.

Regulatory Approval Details

The tentative USFDA approval is for Larotrectinib Capsules in strengths of 25 mg and 100 mg. The product is a kinase inhibitor indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation. The key details of this approval are outlined below:

Parameter	Details
Product	Larotrectinib Capsules (25 mg, 100 mg)
Approval Type	Tentative USFDA Approval
Reference Listed Drug	Vitrakvi Capsules (Bayer Healthcare Pharmaceuticals Inc.)
Estimated Market Size	$91 million (IQVIA, 12 months ending March 2026)
Exclusivity Status	Sole first applicant; eligible for 180 days of generic marketing exclusivity

Significance for US Market Expansion

The tentative approval from the USFDA for Larotrectinib Capsules underscores Alembic Pharmaceuticals' continued focus on expanding its generics pipeline in the United States. With an estimated market size of $91 million, the product represents a meaningful addition to the company's US-facing portfolio. Alembic has a cumulative total of 241 ANDA approvals from the USFDA, comprising 221 final approvals and 20 tentative approvals.