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Alembic Pharmaceuticals' JV Aleor Dermaceuticals receives USFDA Approval for Clobetasol Propionate Spray, 0.05%

Posted On: 2019-10-04 12:50:47


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 Spray, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Clobex® Spray, 0.05% of Galderma Laboratories L.P. (Galderma). Clobetasol Propionate Spray, 0.05% is indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.

Clobetasol Propionate Spray, 0.05%, has an estimated market size of US$ 22 million for twelve months ending December 2018 according to IQVIA.

Alembic has a cumulative total of 103 ANDA approvals (91 final approvals and 12 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.525.55 as compared to the previous close of Rs. 516.55. The total number of shares traded during the day was 1756 in over 124 trades.

The stock hit an intraday high of Rs. 531 and intraday low of 518. The net turnover during the day was Rs. 919680.


Source: Equity Bulls

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