Alembic Pharmaceuticals (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Ivabradine Tablets, 5 mg and 7.5 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Corlanor Tablets, 5 mg and 7.5 mg, of Amgen Inc. (Amgen). Ivabradine is a hyperpolarization-activated cyclic nucleotide-gated channel blocker indicated to reduce the risk of hospitalization for worsening heart failure in adult patients with stable, symptomatic chronic heart failure with reduced left ventricular ejection fraction. Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US$ 145.3 million for twelve months ending September 2024 according to IQVIA. Alembic has a cumulative total of 218 ANDA approvals (192 final approvals and 26 tentative approvals) from USFDA.Powered by Capital Market - Live News

Alembic Pharmaceuticals (Alembic) announced 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 USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD Extended-Release Capsules, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, of Bausch Health US, LLC. Diltiazem Hydrochloride Extended-Release Capsules USP 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 USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of US$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. Powered by Capital Market - Live News

Net profit of Alembic Pharmaceuticals rose 12.34% to Rs 153.41 crore in the quarter ended September 2024 as against Rs 136.56 crore during the previous quarter ended September 2023. Sales rose 3.33% to Rs 1647.98 crore in the quarter ended September 2024 as against Rs 1594.93 crore during the previous quarter ended September 2023. ParticularsQuarter EndedSep. 2024Sep. 2023% Var. Sales1647.981594.93 3 OPM %14.5213.03 - PBDT238.06202.20 18 PBT167.55134.64 24 NP153.41136.56 12 Powered by Capital Market - Live News

Alembic Pharmaceuticals will hold a meeting of the Board of Directors of the Company on 7 November 2024.Powered by Capital Market - Live News

Alembic Pharmaceuticals has successfully completed the United States Food and Drug Administration (USFDA) inspection for its Oncology (Injectable and Oral Solid) Formulation Facility (F-2) located at Panelav. The inspection was successfully completed without any Form 483 observation. The inspection was conducted from 7 October 2024 to 8 October 2024. Powered by Capital Market - Live News