Alembic Pharma shares rose 2.3 per cent on Tuesday, after the company received US Food & Drug Administration (USFDA) final approval for its Abbreviated New Drug Application (ANDA) Macitentan Tablets
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.
Alembic Pharma fell around 3.5 per cent to hit an intraday low of ₹913 on the NSE, after the company reported its June 2025 quarter results
Alembic reports ₹154 crore net profit in Q1FY26, driven by growth in US generics, RoW markets and new launches, despite sequential dip in revenue and profit
Alembic Pharmaceuticals share price rose after the company announced that its wholly-owned subsidiary, Alembic Pharmaceuticals Inc., has acquired Utility Therapeutics Ltd. for approximately $12 mn
Alembic Pharmaceuticals on Monday said it has received the final approval from the US health regulator for its generic Doxorubicin Hydrochloride Liposome injection in different types of cancer. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation, it added. Doxorubicin Hydrochloride Liposome Injection is indicated for the treatment of ovarian Cancer, AIDS-Related Kaposi's sarcoma, and multiple myeloma, the company said. Citing IQVIA data, Alembic said Doxorubicin Hydrochloride Liposome injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2mg/mL) single-dose ...
Alembic Pharmaceuticals share surged after the company received final approval from the USFDA for its ANDA for Doxorubicin Hydrochloride Liposome Injection in two dosage strength.