Alembic Pharma gets USFDA final approval for Cyclophosphamide Capsules

Alembic Pharmaceuticals Limited on Monday has 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.

According to the press release, 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. Refer to our label for full indication.

According to IQVIA, Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market size of US$ 8 million for twelve months ending Sep 2022.

Alembic has a cumulative total of 176 ANDA approvals (152 final approvals and 24 tentative approvals) from USFDA.

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.

For feedback and suggestions, write to us at editorial@iifl.com