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Alembic Pharma gets USFDA nod for Fluphenazine Hydrochloride Tablets
![Alembic Pharma gets USFDA nod for Fluphenazine Hydrochloride Tablets Alembic Pharma gets USFDA nod for Fluphenazine Hydrochloride Tablets](https://medicaldialogues.in/h-upload/2024/02/09/750x450_231897-usfda-50.webp)
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
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: editorial@medicaldialogues.in. Contact no. 011-43720751