Alembic Pharma bags USFDA nod for alkylating drug Cyclophosphamide
Vadodara: Drugmaker Alembic Pharmaceuticals Limited today announced that the company 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 Capsule is an alkylating drug indicated for the treatment of malignant disease and minimal change nephrotic syndrome in pediatric patients.
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Nephrotic syndrome is a collection of symptoms due to kidney damage. The symptoms include significant swelling, high blood lipids, protein in the urine, and low blood albumin levels. Other symptoms may include foamy urine, weight gain, feeling tired.
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 the USFDA.
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Alembic Pharmaceuticals Limited is a vertically integrated research and development pharmaceutical company headquartered in Gujarat. It is involved in manufacturing and marketing India Formulations, International Generics, and Active Pharmaceutical Ingredients with vertical integration capabilities.
Products under International Generics are manufactured across its facilities in Panelav, Karkhadi, and Jarod in Gujarat. Under this vertical, the company also has R&D facilities in Vadodara (Gujarat), Hyderabad (Telangana), and New Jersey (USA).
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