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.

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.

Read also: Alembic Pharma subsidiary bags USFDA nod for Adapalene, Benzoyl peroxide topical gel

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.

Read also: Alembic Pharma bags USFDA approval for Pain relief injection Ketorolac Tromethamine

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).

Read also: Alembic Pharma secures USFDA okay for Mesalamine ER Capsules

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