Alembic Pharmaceuticals

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.

Shares of Alembic Pharmaceuticals rose 5.38 per cent at Rs 1285.60 per share on the BSE on Thursday ahead of the pharma major's financial performance announcement

At 6:47 AM, GIFT Nifty futures indicated a major uptick of 91 points at 24,613, suggesting a gap-up start for the bourses

The drug is expected to be manufactured in Alembic's manufacturing facilities in Gujarat, according to sources close to the company

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Icatibant injection indicated for the treatment of acute attacks of hereditary angioedema in adults. The approval by the US Food & Drug Administration (USFDA) is for the Abbreviated New Drug Application (ANDA) for Icatibant injection of strengths 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe, Alembic Pharmaceuticals said in a regulatory filing. This is the first peptide product approval from the USFDA received by the company, Alembic Pharma said. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Firazyr Injection, 30 mg/3 mL (10 mg/mL), of Takeda Pharmaceuticals USA, Inc, it added. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Hereditary angioedema is a disorder characterised by recurrent episodes of severe swelling (angioedema)

This increase in PAT was attributed to tax deduction, decline in the cost of materials consumed, and improvement in Ebitda