Alembic Pharma Gets USFDA Nod for Generic Acne Drug Tretinoin Cream

Alembic Pharmaceuticals has received final approval from the US Food and Drug Administration (USFDA) to launch Tretinoin Cream USP (0.025%) in the US market. 

Generic Version of Retin-A

The approved cream is the generic equivalent of Retin-A Cream 0.025% developed by Bausch Health US, LLC. Tretinoin cream is widely prescribed for the treatment of acne vulgaris and is applied topically.

Market Opportunity

According to IQVIA data, the US market for Tretinoin Cream USP, 0.025% is valued at $94 million for the twelve months ending June 2025. Alembic’s entry into this space opens up strong revenue potential.

About Alembic Pharmaceuticals

Alembic Pharmaceuticals is a prominent research-driven and fully integrated pharmaceutical company, with a strong focus on developing and producing generic formulations across multiple therapeutic areas.

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Alembic Pharmaceuticals Share Price Movement

Alembic Pharmaceuticals share price (NSE: APLLTD) is currently trading at ₹991.65, reflecting a gain of 2.05%. The stock opened at ₹965.10 and touched a high of ₹999.00 during the day. With a market capitalisation of ₹19,500 crore, the company has a price-to-earnings (P/E) ratio of 32.30. It offers a dividend yield of 1.11%, with a quarterly dividend amount of ₹2.75 per share. Over the past year, the stock has moved between a 52-week high of ₹1,303.90 and a low of ₹725.20.

Conclusion

The USFDA approval marks another milestone for Alembic Pharmaceuticals in strengthening its US generics portfolio. With a sizable market opportunity, this launch could support the company’s future growth.

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