Alembic Pharmaceuticals Ltd News

Alembic Pharmaceuticals gets USFDA nod for generic acne treatment gel

Alembic Pharmaceuticals on Monday said it has received final approval from the US health regulator for the generic version of Dapsone gel indicated for the topical treatment of acne vulgaris. The approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Dapsone gel, 5 per cent, Alembic Pharmaceuticals said in a statement. The approved ANDA is therapeutically equivalent to the reference listed drug product Aczone Gel, 5 per cent of Almirall, LLC, it added. Dapsone gel is indicated for the topical treatment of acne vulgaris, the company said.

Alembic Pharma gets USFDA nod for drug to treat influenza A and B in babies

The drug that has received the final approval from the US regulatory body is Oseltamivir Phosphate for Oral Suspension, 6 mg/mL

Alembic Pharma gets tentative approval from USFDA for generic cancer drug

Alembic Pharmaceuticals Ltd on Friday said it has received tentative approval from the US health regulator for its generic version of cancer treatment drug Binimetinib tablets. The tentative approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) of Binimetinib tablets of strength 45 mg, Alembic Pharmaceuticals said in a regulatory filing. Based on USFDA's paragraph IV certifications list, Alembic is the sole first applicant to have filed its ANDA for Binimetinib Tablets, 45mg and upon final approval of this ANDA by the USFDA, the company may be eligible for 180 days of generic marketing exclusivity in the US, the company said. Alembic had previously received tentative approval for Binimetinib Tablets, 15mg, it added. Binimetinib in combination with encorafenib is used for the treatment of patients with unresectable or metastatic melanoma with resistance to specific targeted therapies in cancer. It is also indicated, in combination

Alembic Pharma shares plunge 9% on soft Q4 results, weak margins drag

Alembic Pharmaceuticals reported a 29 per cent year-on-year (Y-o-Y) rise in consolidated net profit to ₹202 crore as compared to ₹157 crore in the year-ago period

Alembic Pharmaceuticals Q4 FY26 results: Net profit rises 29% at ₹202.7 cr

Alembic Pharmaceuticals Ltd on Friday reported a 29 per cent rise in consolidated net profit at Rs 202.7 crore in the fourth quarter ended March 31, driven by revenue growth across segments. The company had posted a consolidated net profit of Rs 156.89 crore in the corresponding period of previous fiscal, Alembic Pharmaceuticals said in a regulatory filing. Consolidated revenue from operations in the fourth quarter stood at Rs 1,847.72 crore as against Rs 1,769.64 crore in the year-ago period, it added. Total expenses in the quarter under review were at Rs 1,730.94 crore as compared to Rs 1,591.22 crore in the same period a year ago, the company said. Alembic Pharmaceuticals Ltd Managing Director Pranav Amin said,"Q4FY26 reflects disciplined execution across our businesses, supported by continued focus on profitability, operational delivery and long-term growth investments." He further said, "We delivered revenue growth across key segments while maintaining healthy pre-R&D ...

Alembic Pharma gains 4% on getting USFDA nod for Dapagliflozin tablets

Dapagliflozin Tablets is a generic version of AstraZeneca's Farxiga, which had an estimated US market size of $10,487 million for the twelve months ending December 2025

US market remained a drag for Indian pharma in Q3 amid pricing pressure

The US market stayed a weak spot for Indian pharma companies in Q3FY26 amid sustained pricing pressure in generics, heightened competition and product-specific challenges

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