Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for cyclophosphamide capsules, 25 mg and 50 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), cyclophosphamide capsules, 25 mg and 50 mg of Hikma Pharmaceuticals USA Inc. Cyclophosphamide capsules is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome in paediatric patients. Alembic has a cumulative total of 176 ANDA approvals (152 final approvals and 24 tentative approvals) from US FDA. Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India, Alembic is a publicly listed company that manufactures and markets generic pharmaceutical products all over the world.
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