Alembic Pharmaceuticals said that it has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Diltiazem Hydrochloride extended-release capsules.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD extended-release capsules of Bausch Health US, LLC. The approved strengths for the said drug are 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg.
Diltiazem Hydrochloride Extended-Release (ER) capsules are indicated for the treatment of hypertension.
Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications. It is also indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Diltiazem Hydrochloride extended-release capsules have an estimated market size of $105.3 million for twelve months ending June 2024 according to IQVIA.
Alembic has a cumulative total of 218 ANDA approvals (191 final approvals and 27 tentative approvals) from USFDA.
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Alembic Pharmaceuticals is in the business of development, manufacturing, and marketing of Pharmaceuticals products i.e. Formulations and Active Pharmaceutical Ingredients.
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 fell 1.89% to currently trade at Rs 1019.35 on the BSE.
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