Alembic receives USFDA final approval for Dabigatran Etexilate Capsules, 110 mg

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals

Granules India receives ANDA approval for Trazodone Tablets

Trazodone tablets are indicated for the treatment of major depressive disorder in adults

Lupin receives USFDA approval for Prednisolone Acetate Ophthalmic Suspension USP

Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity

Alembic receives USFDA final approval for Nelarabine Injection, 250 mg/50 mL

Nelarabine is a nucleoside metabolic inhibitor indicated for the treatment of patients with T-cell acute lymphoblastic leukemia

Lupin receives approval from USFDA for Emtricitabine and Tenofovir Alafenamide Tablets

This product will be manufactured at Lupin’s Nagpur facility in India and will be supplied to low and middle-income countries

Alembic receives USFDA’s final approval for Fluphenazine Hydrochloride Tablets

Caplin Steriles gets USFDA approval for Ephedrine Sulfate injection USP

Ephedrine Sulfate injection USP, 50 mg/mL is indicated for the treatment of clinically important hypotension

Lupin’s partner ForDoz receives USFDA approval for doxorubicin hydrochloride liposome injection

Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)

Alembic announces USFDA tentative approval for Selexipag for Injection, 1,800 mcg/vial

Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension

Alembic Pharmaceuticals announces USFDA Final Approval for Bromfenac Ophthalmic Solution, 0.07%

The approved ANDA is therapeutically equivalent to the reference listed drug product