Alembic Pharmaceuticals

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 ...

Stocks to Watch today, Nov 17: Maruti Suzuki, Ola Electric, Marico, Lupin

Stocks to Watch Today, November 17, 2025: Marico, Glenmark Pharma, FirstCry, Siemens, Dish TV, Alembic Pharma, Cyient, and Websol Energy System are among the top stocks to remain in focus today

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

Glenmark, Alembic Pharma, Sun Pharma recall drugs in US, says USFDA

Drug makers Glenmark, Alembic Pharmaceuticals and Sun Pharma are recalling products in the US due to manufacturing issues, according to the US health regulator. Mumbai-based Glenmark is recalling two products in the market, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. Glenmark Pharmaceuticals Inc, USA, a subsidiary of the company, is recalling Carvedilol tablets, used to treat heart failure, hypertension, and heart attack, in multiple strengths. The New Jersey-based firm is recalling 55,560 units of the affected lot due to "presence of a nitrosamine, N-Nitroso Carvedilol impurity above the current acceptable intake level," the USFDA stated. The company is also recalling 17,496 bottles of Carvedilol tablets as "results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm," it added. Glenmark initiated the Class II recall in August this year. USFDA said the company is also recalling 2

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.

Alembic Pharma dips 3% post Q1 results; MOFSL retains Neutral, here's why

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 Pharma Q1 net profit rises 14% to ₹154 crore, revenue up 10%

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

Last day alert! Bosch, 11 others go ex-dividend on July 29; do you own any?

Notably, the ex-date marks an important trading session for the stocks as it starts trading without the value of its declared dividend

Alembic Pharmaceuticals up 2% as arm acquires Utility Therapeutics; details

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 Pharma gets USFDA nod for generic cancer treatment injection

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 ...

Why is Alembic Pharmaceuticals' share in demand today? Key details here

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.

Alembic Pharma receives USFDA approval for generic hypertension drug

Alembic Pharmaceuticals on Friday said it has received final approval from the US health regulator for its generic version of amlodipine and atorvastatin tablets, used to treat high blood pressure. The final approval by the US Food & Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) of Amlodipine and Atorvastatin tablets of strengths 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, the company said in a statement. These are therapeutically equivalent to the reference-listed drug product, Caduet tablets of corresponding strengths of Pharmacia and Upjohn Co LLC, it added. Alembic said it has a cumulative total of 223 ANDA approvals (199 final approvals and 24 tentative approvals) from the USFDA.

Alembic Pharma Q4 profit dips 12%, revenue rises 17% to Rs 1,770 cr

India branded business grows 8% in Q4FY25 with 4 product launches while Ex-US markets rise 43% and US segment delivers 20% growth during the quarter

Alembic Pharma down 3% on getting USFDA observation for its Vadodara plant

The filing further read the company will provide a comprehensive response to US FDA for the observations within the stipulated period

Alembic Pharma Q3 results: PAT falls 23.29% amid market headwinds

Alembic's revenue from operations rose to Rs 1,692.74 crore in Q3FY25, a 3.8 per cent Y-o-Y increase from Rs 1,630.57 crore in Q3FY24

Alembic Pharma Q3 result: Profit dips 23% to Rs 138 cr on weak sales

A significant chunk of revenue for most Indian generic drugmaker comes from the U.S. and fierce competition in the North American market has weighed on domestic firms' margins

Stocks to sell on rise: Apollo Tyres, Cyient may fall upto 34%, show charts

Metropolis Healthcare, Alembic Pharma and Tejas Networks are the other 3 stocks to witness a 'Death Cross' on the chart in recent days; technically this is a negative development for these stocks.

Here's why Alembic Pharma was buzzing in trade on December 20, details here

Alembic Pharma share rose after the company announced that it has received final approval from the USFDA for its ANDA Divalproex Sodium Delayed-Release Capsules USP, 125 mg

Alembic Pharma gets tentative USFDA nod for Olopatadine drug; stock up 2%

Alembic has a cumulative total of 219 ANDA approvals (192 final approvals and 27 tentative approvals) from the USFDA

Nifty Pharma jumps over 2%: Analysts decode the drivers behind the rally

Individually, Cipla soared up to 3.68 per cent to hit an intraday high of Rs 1,547.70 per share, while Sun Pharma soared up to 3.30 per cent to hit an intraday high of Rs 1,791.60 per share