Alembic Pharmaceuticals on Thursday announced that it has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for Clomipramine Hydrochloride Capsules.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Anafranil Capsules of SpecGX LLC. Clomipramine Hydrochloride Capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD).According to IQVIA, Clomipramine Hydrochloride Capsules USP have an estimated market size of $32 million for twelve months ending June 2021. Alembic has a cumulative total of 149 ANDA approvals from USFDA.
Shares of Alembic Pharma were trading 1.07% lower at Rs 778 on BSE.
Alembic Pharmaceuticals is a vertically integrated research and development pharmaceutical company. It manufactures and markets generic pharmaceutical products all over the world.
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