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Alembic Pharmaceuticals gets USFDA Final Approval for Desipramine Hydrochloride Tablets USP, 10 mg. 25 mg. 50 mg, 75 mg, 100 mg, and 150 mg



Posted On : 2021-07-08 11:28:57( TIMEZONE : IST )

Alembic Pharmaceuticals gets USFDA Final Approval for Desipramine Hydrochloride Tablets USP, 10 mg. 25 mg. 50 mg, 75 mg, 100 mg, and 150 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) for Desipramine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Norpramin Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, of Validus Pharmaceuticals LLC. Desipramine Hydrochloride Tablets, USP are indicated for the treatment of depression.

Desipramine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg have an estimated market size of US$ 7 million for twelve months ending March 2021 according to IQVIA.

Alembic has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.985.25 as compared to the previous close of Rs. 985.95. The total number of shares traded during the day was 18124 in over 1071 trades.

The stock hit an intraday high of Rs. 991.3 and intraday low of 977.25. The net turnover during the day was Rs. 17841597.

Source : Equity Bulls

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