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Aleor Pharmaceuticals gets USFDA nod for generic antibacterial gel

Aleor Dermaceuticals Ltd has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Metronidazole gel USP, 1 percent, Alembic Pharma said in a regulatory filing.

September 06, 2021 / 01:32 PM IST

Drug firm Alembic Pharmaceuticals on Monday said its joint venture Aleor Dermaceuticals has received approval from the US health regulator for generic Metronidazole gel, used in the treatment of inflammatory lesions of rosacea.

Aleor Dermaceuticals Ltd has received final approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Metronidazole gel USP, 1 percent, Alembic Pharma said in a regulatory filing.

The product is a generic version of Galderma Laboratories LP's Metrogel gel 1 percent, it added.

According to IQVIA, Metronidazole Gel, USP 1 percent, has an estimated market size of USD 29 million for twelve months ending June 2021, Alembic Pharma said.

The product is indicated for the topical treatment of inflammatory lesions of rosacea. Aleor had previously received tentative approval for this ANDA, it added.

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The company has a cumulative total of 149 ANDA approvals (132 final approvals and 17 tentative approvals) from USFDA, Alembic Pharma said.

Shares of Alembic Pharmaceuticals were trading at Rs 783 per scrip on BSE, up 1.10 percent from its previous close.
PTI
first published: Sep 6, 2021 01:32 pm

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