Alembic Pharmaceuticals (Alembic) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, 40 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Oracea Capsules, 40 mg, of Galderma Laboratories, L.P. (Galderma).
Doxycycline capsules are indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Doxycycline Capsules, 40 mg have an estimated market size of $123 million for twelve months ending March 2024 according to IQVIA. The company has a cumulative total of 205 ANDA approvals (179 final approvals and 26 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
