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Alembic Pharmaceuticals Gains USFDA Approval for Tretinoin Cream

Story Highlights
  • Alembic Pharmaceuticals received USFDA approval for Tretinoin Cream USP, 0.025%.
  • The approval could enhance Alembic’s market position in acne treatment with a market size of US$ 94 million.
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Alembic Pharmaceuticals Gains USFDA Approval for Tretinoin Cream

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Alembic Pharmaceuticals Limited ( (IN:APLLTD) ) has issued an announcement.

Alembic Pharmaceuticals Limited has announced that it received final approval from the US Food & Drug Administration (USFDA) for its Tretinoin Cream USP, 0.025%, which is therapeutically equivalent to the reference drug Retin-A Cream by Bausch Health. This approval marks a significant step for Alembic, as the Tretinoin cream has an estimated market size of US$ 94 million as of June 2025, potentially enhancing the company’s market position in the treatment of acne vulgaris. With this approval, Alembic now has a cumulative total of 224 ANDA approvals, reflecting its strong capability in the generic pharmaceutical sector.

More about Alembic Pharmaceuticals Limited

Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company, established in 1907 and headquartered in India. It is a publicly listed company that manufactures and markets generic pharmaceutical products globally. Alembic is recognized as a leader in branded generics in India, with a strong presence supported by a field force of over 5500. The company’s research and manufacturing facilities have approvals from several developed countries’ regulatory authorities, including the USFDA.

Average Trading Volume: 29,568

Technical Sentiment Signal: Strong Buy

Current Market Cap: 188.4B INR

For an in-depth examination of APLLTD stock, go to TipRanks’ Overview page.

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