Aleor Dermaceuticals receives USFDA Final Approval for Adapalene Gel USP, 0.3%

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) Adapalene Gel USP, 0.3%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Differin Gel, 0.3%, of Galderma Laboratories, L.P. (Galderma). Adapalene Gel USP, 0.3% is indicated for the topical treatment of acne vulgaris in patients 12 years of age and older.

Adapalene Gel USP, 0.3% has an estimated market size of US$ 34 million for twelve months ending March 2020 according to IQVIA.

Alembic has a cumulative total of 123 ANDA approvals (110 final approvals and 13 tentative approvals) from USFDA.

Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.908.3 as compared to the previous close of Rs. 917.85. The total number of shares traded during the day was 14712 in over 1441 trades.

The stock hit an intraday high of Rs. 924.6 and intraday low of 902. The net turnover during the day was Rs. 13445051.

Source : Equity Bulls

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