The drug maker has received final approval from the US drug regulator for its Abbreviated New Drug Application (ANDA) doxepin hydrochloride capsules USP, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Sinequan capsules of Pfizer Inc. The drug is is used to treat mental/mood problems such as depression and anxiety.
The capsules have an estimated market size of $41 million for twelve months ending December 2020 according to IQVIA.
Alembic has a cumulative total of 141 ANDA approvals (124 final approvals and 17 tentative approvals) from USFDA.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
The drug maker reported 13.8% jump in consolidated net profit to Rs 259.20 crore on a 8.7% rise in net sales to Rs 1,314.33 crore in Q3 FY21 over Q3 FY20.
The Alembic Pharma scrip was up 0.29% to Rs 1006.65 on the BSE.
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