Zydus Lifesciences gets USFDA’s final approval for Cyclophosphamide Capsules

14 Dec 2023 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Cyclophosphamide Capsules USP, 25 mg and 50 mg (USRLD: Cyclophosphamide Capsules, 25 mg and 50 mg). Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cells. It treats lymphoma, myeloma, leukemia, breast cancer and ovarian cancer. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India. 

Cyclophosphamide Capsules USP, 25 mg and 50 mg had annual sales of $6 million in the United States (IQVIA MAT October, 2023). The group now has 383 approvals and has so far filed over 448 ANDAs (as of September 30, 2023) since the commencement of the filing process in FY 2003-04. 

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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