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.
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.
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
The filing further read the company will provide a comprehensive response to US FDA for the observations within the stipulated period
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
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
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.
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 has a cumulative total of 219 ANDA approvals (192 final approvals and 27 tentative approvals) from the USFDA
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
Alembic Pharma share price surged after the United States Food and Drug Administration (USFDA) gave final approval for Lamotrigine ExtendedRelease Tablets USP, 200 mg, 250 mg, and 300 mg.
Alembic Pharma share price surged after the USFDA issued establishment inspection report (EIR) for the inspection carried out at the company's Oral Solid Formulation Facility (F-I).
Alembic Pharma share price surged up to 5 per cent at Rs 1,170.60 per share on the BSE in Thursday's intraday trade
Shares of Alembic Pharmaceuticals soared up to 4.13 per cent at Rs 1,135 per share on the BSE
The surge in Alembic Pharma share price came after the company announced that it has received US Food & Drug Administration (USFDA) final approval for Betamethasone Valerate Foam, 0.12 per cent.
Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic product indicated for prophylaxis of deep vein thrombosis. The company has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), the drug firm said in a regulatory filing. Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. The approved product is therapeutically equivalent to Boehringer Ingelheim Pharmaceuticals Inc's Pradaxa Capsules (110 mg). The company said it now has a cumulative total of 211 ANDA (abbreviated new drug application) approvals from the USFDA. Shares of the company on Tuesday closed 3.17 per cent down at Rs 1,076 apiece on the BSE.
For the quarter, the India Branded Business segment saw a 9 per cent growth, reaching Rs 572 crore
Alembic Pharmaceuticals on Thursday said its consolidated net profit increased by 12 per cent to Rs 135 crore for the first quarter ended on June 30, 2024. The drug firm had reported a net profit of Rs 121 crore for the April-June quarter of last fiscal. Total income increased to Rs 1,564 crore for the June quarter as against Rs 1,498 crore in the year-ago period, Alembic Pharmaceuticals said in a regulatory filing. "India branded business continues to work on improving the execution ability both in quality and scale," Alembic Pharmaceuticals MD Shaunak Amin said. The specialty and animal health segment witnessed robust growth, he added. "The USFDA conducted an audit at our formulation facility F1, without any observations, underscoring our dedication to compliance and quality. The US business grew by 18 per cent during the quarter," Amin said. Shares of the company ended 0.11 per cent down at Rs 1,218.65 apiece on the BSE.