Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules USP, 75 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Monodox Capsules, 75 mg and 100 mg, of Aqua Pharmaceuticals. Doxycycline Capsules are indicated for the treatment and prevention of infections that are proven or strongly suspected to be caused by bacteria.
Doxycycline Capsules USP, 75 mg and 100 mg, have an estimated market size of $30 million for twelve months ending December 2016 according to IMS. Alembic now has a total of 62 ANDA approvals (54 final approvals and 8 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.
