Alembic Pharmaceuticals’ (Alembic) joint venture Aleor Dermaceuticals (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% has an estimated market size of $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.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
| Company Name | CMP |
|---|---|
| Sun Pharma Inds. | 1847.30 |
| Dr. Reddys Lab | 1293.25 |
| Cipla | 1347.70 |
| Zydus Lifesciences | 938.90 |
| Lupin | 2377.90 |
| View more.. | |
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