Alembic Pharmaceuticals obtained final approval from the United States Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and seventy five mg. The permitted ANDA is therapeutically equal to the reference indexed drug product (RLD), Anafranil Capsules, 25 mg, 50 mg, and 75 mg, of SpecGX LLC. Clomipramine Hydrochloride Capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD).
Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and seventy five mg, have an estimated marketplace size of US$ 32 million for twelve months ending June 2021 consistent with IQVIA.
Alembic has a cumulative general of 149 ANDA approvals (131 final approvals and 18 tentative approvals) from USFDA.
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