Alembic Pharma receives USFDA nod for Desipramine Hydrochloride tablets

On Thursday, Alembic Pharmaceuticals announced that it has received final approval from United States 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 & 150 mg.  

The abovementioned drug is indicated for the treatment of depression and is therapeutically equivalent to the reference listed drug product (RLD), Norpramin tablets of Validus Pharmaceuticals.   

According to data from IMS Health (IQVIA), Desipramine Hydrochloride tablets in the strengths of 10 mg, 25 mg, 50 mg, 75 mg, 100 mg & 150 mg have an estimated market size of US$ 7 million for twelve months ending March 2021.   

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

On Thursday, the stock of Alembic Pharmaceuticals Limited closed at Rs 984.15, down by 0.14 per cent or 1.35 per share as against a 0.92 per cent decline in the benchmark index.  The 52-week high and the 52-week low of the scrip were recorded at Rs 1,150 and Rs 863.55, respectively on BSE.