Alembic Pharmaceuticals has acquired very last approval from america Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Cyclophosphamide Capsules, 25 mg and 50 mg. The permitted ANDA is therapeutically equivalent to the reference indexed drug product (RLD), Cyclophosphamide Capsules, 25 mg and 50 mg, of Hikma Pharmaceuticals USA Inc. Cyclophosphamide Capsules is an alkylating drug indicated for the remedy of malignant disorder and minimum trade nephrotic syndrome in pediatric patients. Refer to our label for full indication.
Cyclophosphamide Capsules, 25 mg and 50 mg, have an estimated market length of US$ eight million for one year finishing Sep 2022 consistent with IQVIA.
Alembic has a cumulative general of 176 ANDA approvals (152 very last approvals and 24 tentative approvals) from USFDA.
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