Alembic Pharma Gets USFDA Nod for Fluphenazine Hydrochloride Tablets

Alembic Pharmaceuticals announced on Wednesday, July 24, that it 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.

Key Takeaways from Alembic Pharma’s Nod for ANDA

• Alembic Pharmaceuticals has received USFDA final approval for Fluphenazine Hydrochloride Tablets 
• It will be available in 1 mg, 2.5 mg, 5 mg, and 10 mg strengths.
• The approved drug is therapeutically equivalent to the reference listed drug (RLD), Prolixin, 1 mg, 2.5 mg, 5 mg, and 10 mg, of Apothecon Inc.

The approved Abbreviated New Drug Application is therapeutically equivalent to the reference listed drug product (RLD), Prolixin Tablets, 1 mg, 2.5 mg, 5 mg, and 10 mg, of Apothecon Inc. (Apothecon). 

Fluphenazine hydrochloride tablets and USP are used in the management of manifestations of psychotic disorders.

About Alembic Pharmaceuticals Limited

Since 1907, Alembic Pharmaceuticals Limited, a vertically integrated pharmaceutical research and development corporation, has led the way in the field of healthcare. Alembic, a publicly traded company with its headquarters in India, is a global manufacturer and marketer of generic pharmaceutical goods. 

Alembic Pharma’s healthcare products cater to 10 therapeutic areas in the domestic market, offering unmatched quality and on-time delivery to clients. The company has the capacity and influence to reach over 175,000 doctors across its 17 therapy-focused marketing divisions, holding a 1.5% share in the domestic market. The manufacturing facility in Sikkim is dedicated to producing the company's India Formulations.

Regulators in numerous developed nations, including the USFDA, have approved Alembic's cutting-edge research and manufacturing facilities. In India, Alembic is a prominent player in the branded generics market. Physicians and patients alike are familiar with Alembic's brands, which are promoted by a staff of more than 5000 marketers. 

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