Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fenofibrate Tablets USP, 48 mg and 145 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 48 mg and 145 mg, of AbbVie Inc. (AbbVie).
According to IQVIA, Fenofibrate Tablets USP, 48 mg and 145 mg have an estimated market size of $ 94 million for twelve months ending December 2018. The company now has a total of 102 ANDA approvals (90 final approvals and 12 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 |
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