Alembic Pharmaceuticals Ltd News

Alembic Pharmaceuticals gets nod for generic Parkinson's treatment tablets

Alembic Pharmaceuticals Ltd on Friday said it has received approval from the US health regulator for its generic version of Carbidopa, Levodopa and Entacapone tablets used in treatment of Parkinson's disease. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Carbidopa, Levodopa and Entacapone tablets of strengths 12.5 mg/50 mg/200 mg; 18.75 mg/75 mg/200 mg; 25 mg/100 mg/200 mg; 31.25 mg/125 mg/200 mg; 37.5 mg/150 mg/200 mg; and 50 mg/200 mg/200 mg, Alembic Pharmaceuticals Ltd said in a regulatory filing. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo tablets of similar strengths of Orion Corporation, it added. Carbidopa, levodopa and entacapone tablets are indicated for the treatment of Parkinson's disease, the company said.

Alembic Pharma shares slide 4% on Q3 profit miss; is it a good time to buy?

Alembic Pharma shares today: Analysts at Motilal Oswal Financial Services (MOFSL) have retained their Neutral rating on Alembic Pharma, with a target price of ₹860 per share

Alembic to skip first wave of global semaglutide launches, eyes India

Alembic Pharmaceuticals said it will miss the first wave of global generic semaglutide launches but is exploring partnerships for a faster entry into the Indian market

Alembic gets USFDA nod for generic eye infection treatment suspension

Alembic Pharmaceuticals Ltd on Thursday said it has received final approval from the US health regulator for its generic version of Loteprednol Etabonate and Tobramycin ophthalmic suspension used for treatment of eye infection. The approval granted by the US Food & Drug Administration (USFDA) for the Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension of strength 0.5 per cent/0.3 per cent (5 mL and 10 mL), Alembic Pharmaceuticals Ltd said in a regulatory filing. Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialisation, it added. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5 per cent/0.3 per cent, of Bausch & Lomb Incorporated, the company said. Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5 per cent/0.3 per cent, is ...

Alembic Pharma shares rise 2% on pulmonary hypertension drug approval

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 gets USFDA's approval for generic acne drug Tretinoin Cream

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.