Alembic Pharmaceuticals Limited informed the exchanges that the Company has received various US Food & Drug Administration (USFDA) (Tentative or Final) Product Approvals. The summary statement giving brief of all product approvals received from 1st April, 2024 till 8th May, 2024 is enclosed for your information and records. Alembic has a cumulative total of 201 ANDA approvals (173 final approvals and 28 tentative approvals) from USFDA.

Product Name: Diazepam Injection USP, 10 mg/2 mL (5 mg/mL), Single-Dose Prefilled Syringe. Approval Final/Tentative: Final. Innovator Name: Hoffmann LA Roche.

Inc. Brand name: Valium® (Diazepa m) Injection Indication Diazepam Injection USP Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Product Name: Selexipag, Tablets 1,000 mcg and 1,200 mcg. Tentative, Actelion Pharmaceuticals Inc. Uptravi, 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.

Binimetinib, Tentative, Array Biopharm Mektovi Binimetinib 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. Tretinoin Cream USP, 0.1%, Final, Bausch Health US, LLC., USA, Retin-A, Tretinoin Cream is indicated for topical application in the treatment of acne vulgaris. Clindamycin Phosphate.

Topical Gel USP, 1%, Final, Pharmacia & Upjohn Cleocin T, Clindamycin phosphate gel is indicated in the treatment of acne vulgaris.