Alembic Pharmaceuticals JV Aleor receives USFDA approval for Metronidazole Gel


Alembic Pharmaceuticals Limited (Alembic)  announced on Tuesday 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 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.

On Sensex, Alembic closed at Rs1006.80  per piece up by 2.42%. 

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( With inputs from indiainfoline)