Alembic Receives USFDA Approval for Tretinoin Cream; Shares Rise 1.40%

Mumbai, June 12: Alembic Pharmaceuticals received final approval from the US Food & Drug Administration for its Abbreviated New Drug Application for Tretinoin Cream USP, 0.05%.

The approved product is therapeutically equivalent to the reference listed drug Retin-A Cream, 0.05%, marketed by Bausch Health US LLC. The company stated that the product is indicated for topical application in the treatment of acne vulgaris, according to an exchange filing submitted on Friday.

According to a company release, Tretinoin Cream USP, 0.05%, has an estimated market size of US$76 million for the twelve months ended March 2026, based on IQVIA data.

The pharmaceutical company also disclosed that it now holds a cumulative total of 242 ANDA approvals from the USFDA, comprising 222 final approvals and 20 tentative approvals.

Stock Market Snapshot

Alembic Pharmaceuticals share price moved higher after the company announced the USFDA approval for its dermatology-focused generic product.

As of 1:13 PM IST on June 12, 2026, shares of Alembic Pharmaceuticals Ltd were trading at ₹744.90 on the NSE, up 1.40% from the previous close of ₹734.65.

The market reaction followed investor assessment of the company’s expanding US generics portfolio and continued regulatory clearances in the regulated pharmaceutical market.

The Alembic share price movement also reflected broader interest in export-oriented pharmaceutical companies securing additional approvals in the United States market.

Company Background

Alembic Pharmaceuticals Ltd is a vertically integrated pharmaceutical company engaged in the research, development, manufacturing and marketing of generic pharmaceutical products.

Headquartered in India, the company operates manufacturing and research facilities approved by multiple global regulatory authorities including the USFDA.

Alembic has built a presence across therapeutic segments and continues to expand its regulated market portfolio through ANDA filings and product approvals. The company stated that its brands are supported by a field force of more than 5,500 personnel.

The pharmaceutical manufacturer traces its operations back to 1907 and remains active across domestic and international formulations markets.

Conclusion

The USFDA final approval for Tretinoin Cream USP, 0.05%, further expands Alembic Pharmaceuticals’ portfolio in the US generics market.

The approval adds another dermatology product to the company’s regulated market pipeline and strengthens its cumulative ANDA approval base. Investors tracked the development as the company continued to increase its presence in the US pharmaceutical market through new product launches and regulatory clearances.

Source:

• https://www.nseindia.com/get-quote/equity/APLLTD/Alembic-Pharmaceuticals-Limited
• https://nsearchives.nseindia.com/corporate/APLLTD_12062026124334_Intimation_to_SE_Press_Release_FA_S.pdf