Alembic Pharma gets USFDA nod for Fluphenazine Hydrochloride Tablets
Vadodara: Alembic Pharmaceuticals Limited today announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Prolixin Tablets, 1 mg, 2.5 mg, 5mg, and 10 mg, of Apothecon Inc.
Fluphenazine hydrochloride tablets, USP are indicated in the management of manifestations of psychotic disorders.
Alembic has a cumulative total of 210 ANDA approvals (182 final approvals and 28 tentative approvals) from USFDA.
Headquartered in India, Alembic Pharmaceuticals Limited is a publicly listed company that 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.
Read also: Alembic Pharma receives 11 USFDA product approvals (final & tentative) during quarter ended 30 June
