Alembic Pharmaceuticals announces USFDA Final Approval for Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg

Alembic Pharmaceuticals Limited (Alembic) today announced 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. 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. (Apothecon). Fluphenazine hydrochloride tablets, USP are indicated in the management of manifestations of psychotic disorders. Refer label for a detailed indication.

Alembic has a cumulative total of 210 ANDA approvals (182 final approvals and 28 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 1085.65 as compared to the previous close of Rs. 1119.50. The total number of shares traded during the day was 34105 in over 3202 trades.

The stock hit an intraday high of Rs. 1143.35 and intraday low of 1068.90. The net turnover during the day was Rs. 37743689.00.

Source : Equity Bulls

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AlembicPharmaceuticals INE901L01018 USFDA FinalApproval FluphenazineHydrochloride Tablets