Alembic Pharmaceuticals receives 8 USFDA approvals

Vadodara : Alembic Pharmaceuticals Limited on December 2 announced that it has received US Food & Drug Administration (USFDA) approvals on eight of its Abbreviated New Drug Application (ANDA) in Q3FY24.

A company spokesperson said that Alembic has received five final approvals that includes  Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg and 1,600 mcg, Dapsone gel, 7.5 percent, Fluorouracil Injection USP 5g/100mL (50 mg/mL), Pharmacy Bulk Package (Vial), Carmustine for Injection USP 100 mg/vial (Single-dose Vial) and Acyclovir Cream, 5 percent.

The Company has also received three tentative approvals that includes  Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg, Dapsone gel, 7.5%, Bromfenac Ophthalmic Solution, 0.07%., and Osimertinib Tablets, 40 mg and 80 mg.

Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,400 mcg and 1,600 mcg with brand name Uptravi Tablets of Actelion Pharmaceuticals US, Inc. The medication is indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH.

Rivaroxaban Tablets USP, 2.5 mg, 10 mg, 15 mg, and 20 mg with brand name of Xarelto Tablets of Janssen Pharmaceuticals, Inc. are indicated to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation. It is also used for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), for the reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months.

These tablets also used for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery and for the prophylaxis of venous thromboembolism (VTE) and VTE related death during hospitalization and post hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding, he said.

The spokesperson further added that these tablets also used in combination with aspirin, is indicated to reduce the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI) and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).

Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. A publicly listed company, it manufactures and markets generic pharmaceutical products all over the world. Alembic’s state of the art research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA.

Alembic is one of the leaders in branded generics in India. Alembic’s brands, marketed through a marketing team of over 5000 are well recognized by doctors and patients.