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Zydus Cadila gets USFDA approval for generic drug

The company has received approval from the US Food and Drug Administration (USFDA) to market in the US its generic version in strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg

31st May, 2021 Mumbai

Drug firm Zydus Cadila on Saturday said it has received final approval from the US health regulator to market Fluphenazine Hydrochloride tablets, used in the treatment of certain type of mental ailments.

Zydus Cadila said, the company has received approval from the US Food and Drug Administration (USFDA) to market in the US its generic version in strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg

The medication is used to treat symptoms of a certain type of mental/mood condition (schizophrenia).

Fluphenazine belongs to a class of medications called phenothiazines and is also referred to as a neuroleptic.

The drug will be manufactured at the group's formulation manufacturing facility at the SEZ, Ahmedabad, Zydus Cadila stated.

The group now has 318 approvals and has so far filed over 400 Abbreviated New Drug Applications (ANDAs) since it commenced the filing process in 2003-04.

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