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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.
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.
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)