Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Sacubitril and Valsartan Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Entresto Tablets, 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, of Novartis Pharmaceuticals Corporation (Novartis). Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. It is also indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in paediatric patients aged one year and older. Sacubitril and Valsartan Tablets have an estimated market size of US$ 5.3 billion for twelve months ending March 2024 according to IQVIA.Alembic has a cumulative total of 202 ANDA approvals (174 final approvals and 28 tentative approvals) from USFDA.Powered by Capital Market - Live News

Net profit of Alembic Pharmaceuticals rose 16.78% to Rs 178.21 crore in the quarter ended March 2024 as against Rs 152.60 crore during the previous quarter ended March 2023. Sales rose 7.86% to Rs 1516.98 crore in the quarter ended March 2024 as against Rs 1406.45 crore during the previous quarter ended March 2023.For the full year,net profit rose 80.07% to Rs 615.82 crore in the year ended March 2024 as against Rs 341.99 crore during the previous year ended March 2023. Sales rose 10.19% to Rs 6228.63 crore in the year ended March 2024 as against Rs 5652.62 crore during the previous year ended March 2023. ParticularsQuarter EndedYear Ended�Mar. 2024Mar. 2023% Var.Mar. 2024Mar. 2023% Var. Sales1516.981406.45 8 6228.635652.62 10 OPM %17.1214.49 -14.9711.98 - PBDT252.33190.29 33 904.50630.02 44 PBT182.85116.17 57 631.83354.59 78 NP178.21152.60 17 615.82341.99 80 Powered by Capital Market - Live News

Alembic Pharmaceuticals announced that the Board of Directors of the Company at its meeting held on 9 May 2024, inter alia, have recommended the final dividend of Rs 11 per equity Share (i.e. 550%) , subject to the approval of the shareholders.Powered by Capital Market - Live News

Alembic Pharmaceuticals has received various US Food & Drug Administration (USFDA) (Tentative or Final) product approvals during the period 01 April 2024 to 08 May 2024. These include:- Final approval for Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), SingleDose Prefilled SyringeDiazepam Injection USP Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety.- Tentative approval for Selexipag Tablets 1,000 mcg and 1,200 mcg.Selexipag tablets are indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. - Tentative approval for BinimetinibBinimetinib tablet is a kinase inhibitor indicated, in combination with encorafenib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.- Final approval for Tretinoin Cream USP, 0.1%Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris.- Final approval for Clindamycin Phosphate Topical Gel USP 1%Clindamycin phosphate gel is indicated in the treatment of acne vulgaris. Powered by Capital Market - Live News

Alembic Pharmaceuticals announced that the company has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (US FDA) for the inspection carried out by them at the company`s Oncology (Injectable and Oral Solid) Formulation Facility (F-2) at Panelav from 28 February 2024 to 8 March 2024.Powered by Capital Market - Live News