Alembic Pharmaceuticals Limited (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg. The approved ANDA is therapeutically equivalent to the reference listed 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 75 mg, have an estimated market size of US$ 32 million for twelve months ending June 2021 according to IQVIA.
Alembic has a cumulative total of 149 ANDA approvals (131 final approvals and 18 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LIMITED was last trading in BSE at Rs. 787 as compared to the previous close of Rs. 785.85. The total number of shares traded during the day was 21978 in over 1274 trades.
The stock hit an intraday high of Rs. 795.1 and intraday low of 781.85. The net turnover during the day was Rs. 17316853.