Alembic Pharmaceuticals clinches eight USFDA approvals in Q3 FY24

Alembic Pharmaceuticals received eight Abbreviated New Drug Application (ANDA) approvals from the US Food and Drug Administration (USFDA) in the third quarter of the financial year 2024 (Q3 FY24). These approvals will help Alembic expand its generic drug portfolio in the US market.

"Alembic has a cumulative total of 196 ANDA approvals with 170 final approvals and 26 tentative approvals from USFDA," the company stated in the regulatory filing on Tuesday.

The green light from the US FDA covers a diverse range of medications. Among the final approvals are Selexipag Tablets, which are used for treating pulmonary arterial hypertension [PAH] and delaying disease progression; Dapsone Gel, which is used for the topical treatment of acne vulgaris; Fluorouracil Injection, which is used for treating several types of cancer, including colon, rectum, breast, and pancreas; and Acyclovir Cream, which is used in treating recurrent cold sores.

The tentative approvals include Rivaroxaban Tablets, which are used to prevent stroke and blood clots in various conditions like atrial fibrillation and deep vein thrombosis; Carmustine for Injection, which provides palliative therapy for brain tumours and certain types of lymphoma; Bromfenac Ophthalmic Solution, which reduces pain and inflammation after cataract surgery; and Osimertinib Tablets, which are used for therapy for specific types of non-small cell lung cancer (NSCLC).

The same day, Alembic Pharma’s share price rose to 3.55 per cent, ending the day's trade at Rs 792 apiece on the BSE.