Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zanaflex Capsules, 2 mg, 4 mg, and 6 mg, of Covis Pharma B.V. Tizanidine hydrochloride is a central alpha-2-adrenergic agonist indicated for the management of spasticity.
Tizanidine Hydrochloride Capsules, 2 mg, 4 mg, and 6 mg have an estimated market size of $ 28 million for twelve months ending September 2019 according to IQVIA.
The company has a cumulative total of 111 ANDA approvals (99 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.
