Alembic Pharmaceuticals receives USFDA Final Approval for Cyclophosphamide Capsules, 25 mg and 50 mg

Alembic Pharmaceuticals Limited (Alembic) today 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.

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

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 638.75 as compared to the previous close of Rs. 616.05. The total number of shares traded during the day was 6314 in over 836 trades.

The stock hit an intraday high of Rs. 644.45 and intraday low of 610.75. The net turnover during the day was Rs. 3944644.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA ANDA CyclophosphamideCapsules FinalApproval