Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Topical Solution USP, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Temovate Topical Solution, 0.05%, of Fougera Pharmaceuticals Inc. (Fougera). Clobetasol Propionate Topical Solution USP, 0.05% is indicated for short-term topical treatment of inflammatory and pruritic manifestations of moderate to severe corticosteroid-responsive dermatoses of the scalp.
Clobetasol Propionate Topical .Solution USP, 0.05%, has an estimated market size of US$ 33 million for twelve months ending December 2018 according to IQVIA.
Alembic has a cumulative total of 104 ANDA approvals (92 final approvals and 12 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.541.3 as compared to the previous close of Rs. 547.65. The total number of shares traded during the day was 2587 in over 217 trades.
The stock hit an intraday high of Rs. 565 and intraday low of 536.5. The net turnover during the day was Rs. 1419709.