Alembic Pharmaceuticals gets final USFDA nod for Cyclophosphamide capsules

Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) 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 pediatric patients.

Cyclophosphamide capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022 according to IQVIA. The company has received approval from the US Food and Drug Administration (USFDA) to market its product which is a generic version of Hikma Pharmaceuticals USA Inc product, Alembic Pharmaceuticals said in a statement. Alembic has a cumulative total of 176 ANDA approvals (152 final approvals and 24 tentative approvals) from USFDA. Shares of Alembic Pharmaceuticals ended at Rs 610.50, 5.65 percent higher. The company will declare its September quarter results on November 11. At around 10:21 AM, Alembic Pharmaceuticals Ltd is currently trading at Rs632.50 per share down by Rs6.25 or 0.98% from its previous closing of Rs638.75 per share on the BSE.