Alembic Pharmaceuticals Limited (Alembic) today announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Metronidazole Gel USP, 1 %. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Metrogel Gel, 1 %, of Galderma Laboratories LP (Galderma). Metronidazole Gel USP, 1 % is indicated for Indicated for the topical treatment of inflammatory lesions of rosacea.
Metronidazole Gel USP, 1 % has an estimated market size of US$ 32 million for twelve months ending December 2020 according to IQVIA.
Alembic has a cumulative total of 142 ANDA approvals (124 final approvals and 18 tentative approvals) from USFDA.
Shares of ALEMBIC PHARMACEUTICALS LTD. was last trading in BSE at Rs.983 as compared to the previous close of Rs. 985.45. The total number of shares traded during the day was 26650 in over 621 trades.
The stock hit an intraday high of Rs. 999.4 and intraday low of 976.2. The net turnover during the day was Rs. 26202260.