Alembic Pharmaceuticals has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg.
The said drug is therapeutically equivalent to the reference listed drug product (RLD), Dilacor XR extended-release capsules, 120 mg, 180 mg, and 240 mg, of Allergan Sales LLC (Allergan).Diltiazem Hydrochloride extended-release capsules USP is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications, such as diuretics. It is also indicated for the management of chronic stable angina. Refer label for a detailed indication.
The said drug has estimated market size of $28.2 million for twelve months ending June 2024 according to IQVIA.
Alembic has a cumulative total of 217 ANDA approvals (190 final approvals and 27 tentative approvals) from USFDA.
Alembic Pharmaceuticals is in the business of development, manufacturing, and marketing of Pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.
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The pharmaceutical companys consolidated net profit increased 11.69% to Rs 134.71 crore in Q1 FY25 as compared to Rs 120.60 crore posted in Q1 FY24. Revenue from operations grew 5.09% year on year (YoY) to Rs 1,561.73 crore in the quarter ended 30 June 2024.
The scrip rose 0.73% to Rs 1,168.25 on the BSE.
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