Latest news with #Tretinoin
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Business Standard
41 minutes ago
- Business
- Business Standard
Alembic Pharma shares rise 2% on pulmonary hypertension drug approval
Alembic Pharmaceuticals shares rose 2.3 per cent on Tuesday, August 19, 2025, logging an intra-day high at ₹996.15 per share on BSE. At 11:29 AM, Alembic Pharmaceuticals share price was trading 1.88 per cent higher at ₹991.55 per share. In comparison, the Sensex was 0.27 per cent higher at 81,491.26. Why were Alembic Pharmaceuticals shares rising? Alembic Pharmaceuticals shares were in demand after the company received US Food & Drug Administration (USFDA) final approval for its Abbreviated New Drug Application (ANDA) Macitentan Tablets, 10 mg, used to treat pulmonary arterial hypertension in adults. The drug has an estimated US market size of $1.18 billion for the twelve months ending June 2025, according to IQVIA. This brings Alembic's total USFDA approvals to 224 (203 final, 21 tentative). That apart, the company also received final approval for Tretinoin Cream USP (0.025 per cent). The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025 per cent, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. According to IQVIA, Tretinoin cream USP, 0.025 per cent, has an estimated market size of USD 94 million for the twelve months ending June 2025. Check List of Q1 results today Alembic Pharmaceuticals Q1 results The company reported a 14 per cent increase in consolidated net profit year-on-year (Y-o-Y) to ₹154.33 crore for the Q1FY26 compared to ₹131.21 crore in the year-ago period. Revenue from operations also rose by 10 per cent Y-o-Y to ₹1,710.72 crore against ₹1,561.73 crore in Q1FY25. About Alembic Pharmaceuticals Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world. Alembic's research and manufacturing facilities are approved by regulatory authorities of many developed countries, including the USFDA. Alembic is one of the leaders in branded generics in India. Alembic's brands, marketed through a field force of over 5500, are well recognized by doctors and patients.
Economic Times
a day ago
- Business
- Economic Times
Alembic gets USFDA nod for generic drug for skin condition
Synopsis Alembic Pharmaceuticals has secured USFDA approval for its generic Tretinoin Cream USP (0.025%), a treatment for acne vulgaris. This ANDA is therapeutically equivalent to Bausch Health US, LLC's Retin-A Cream. The market size for Tretinoin cream USP (0.025%) is estimated at USD 94 million for the twelve months ending June 2025. Agencies Alembic (Representative image) Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic medication to treat acne vulgaris in the US market. The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP (0.025 per cent), the drug maker said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025 pr cent, of Bausch Health US, LLC, it added. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. According to IQVIA, Tretinoin cream USP, 0.025 per cent, has an estimated market size of USD 94 million for the twelve months ending June 2025. Shares of the company were trading 1.03 per cent up at Rs 968.10 apiece on BSE.
Time of India
a day ago
- Business
- Time of India
Alembic gets USFDA nod for generic drug for skin condition
Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic medication to treat acne vulgaris in the US market. Independence Day 2025 Modi signals new push for tech independence with local chips Before Trump, British used tariffs to kill Indian textile Bank of Azad Hind: When Netaji Subhas Chandra Bose gave India its own currency The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP (0.025 per cent), the drug maker said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025 pr cent, of Bausch Health US, LLC, it added. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. According to IQVIA, Tretinoin cream USP, 0.025 per cent, has an estimated market size of USD 94 million for the twelve months ending June 2025. Shares of the company were trading 1.03 per cent up at Rs 968.10 apiece on BSE.
News18
a day ago
- Business
- News18
Alembic gets USFDA nod for generic drug for skin condition
New Delhi, Aug 18 (PTI) Alembic Pharmaceuticals on Monday said it has received approval from the US health regulator to market a generic medication to treat acne vulgaris in the US market. The company has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Tretinoin Cream USP (0.025 per cent), the drug maker said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025 pr cent, of Bausch Health US, LLC, it added. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. According to IQVIA, Tretinoin cream USP, 0.025 per cent, has an estimated market size of USD 94 million for the twelve months ending June 2025. Shares of the company were trading 1.03 per cent up at Rs 968.10 apiece on BSE. PTI MSS MSS DR DR view comments First Published: August 18, 2025, 14:00 IST Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.
Business Standard
3 days ago
- Business
- Business Standard
Alembic Pharmaceuticals receives USFDA approval for Tretinoin Cream USP
Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.025%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Retin-A Cream, 0.025%, of Bausch Health US, LLC. Tretinoin cream is indicated for topical application in the treatment of acne vulgaris. Tretinoin cream USP, 0.025%, has an estimated market size of US$ 94 million for twelve months ending June 2025 according to IQVIA.
