Latest news with #TretinoinCreamUSP
Economic Times
20 hours 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
20 hours 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
20 hours 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 Upturn
a day ago
- Business
- Business Upturn
Top stocks to watch today, August 18: JK Cement, Swiggy, KEC International, Alembic Pharmaceuticals, Glenmark, auto stocks and more
By Aditya Bhagchandani Published on August 18, 2025, 08:20 IST Markets will track sector-specific developments and company announcements on Monday, August 18. Key updates span GST rationalisation measures, capex plans, earnings, and trade duty recommendations. Positive cues Steel companies may see momentum after the Directorate General of Trade Remedies (DGTR) recommended safeguard duty on imports of non-alloy and alloy steel flat products. Automakers are also in focus as sources indicate GST rationalisation could lead to lower taxes on two-wheelers and cars. FMCG firms are expected to benefit from tax cuts on daily-use items, while consumer durable majors such as Voltas, Blue Star, and Havells could gain if GST on ACs, TVs, refrigerators, and washing machines is reduced to 18%. Insurance companies are in spotlight as sources suggest the Centre is considering reducing GST on insurance premiums to 0% or 5%. JK Cement will be tracked after its board approved a Rs 4,805 crore capex for a 7 mt cement line in Rajasthan. Supreme Industries and Astral may move after DGTR recommended anti-dumping duty on PVC suspension resin imports. Among individual stocks, Alembic Pharmaceuticals received final US FDA approval for Tretinoin Cream USP, with an estimated market size of USD 94 million. KEC International reported fresh orders worth Rs 1,402 crore across businesses. Signature Global executed three sale deeds to purchase 33.47 acres of land in Sohna, Haryana. Swiggy increased its platform fee to Rs 14 in select regions. Zaggle Prepaid posted a 37% rise in EBITDA with margins improving to 9.2% from 8.8% YoY, while Borosil reported a 14% rise in EBITDA with margins at 16.2% against 15% YoY. SP Apparels delivered strong results with EBITDA up 60% and revenue up 64% YoY. Negative cues Glenmark's earnings showed flat revenue with margins slipping to 17.8% from 18%. Vodafone Idea posted a 1% decline in EBITDA with margins easing to 41.8% from 42.3% sequentially. Textile and chemical companies may face pressure as a 25% additional tariff is expected to take effect on August 27. Inox Wind reported flat margins and Q1 FY26 execution below estimates. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
Business Standard
3 days ago
- Business
- Business Standard
Alembic Pharma secures USFDA nod for generic acne cream
Alembic Pharmaceuticals said on Friday it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tretinoin Cream USP, 0.025%. The product is therapeutically equivalent to Bausch Health's Retin-A Cream, 0.025%, and is indicated for the topical treatment of acne vulgaris. The cream has an estimated market size of $94 million for the 12 months ended June 2025, according to IQVIA. With this nod, Alembics cumulative ANDA approvals now stand at 224, including 202 final and 22 tentative approvals. Alembic Pharmaceuticals is a vertically integrated research-driven company that manufactures and markets generic medicines globally. The company's consolidated net profit jumped 14.18% to Rs 156.63 crore while revenue from operations grew 9.54% to Rs 1,710.72 crore in Q1 June 2025 over Q1 June 2024.
