Zydus receives final approval from the USFDA for Cyclophosphamide Capsules USP, 25 mg and 50 mg

Zydus receives final approval from the USFDA for Cyclophosphamide Capsules USP, 25 mg and 50 mg Ahmedabad, India, December 14, 2023 Zydus Lifesciences Limited (including its subsidiaries/affiliates, hereafter referred to as “Zydus”) 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 USD 6 mn in the United States (IQVIA MAT October,2023). The group now has 383 approvals and has so far filed over 44 8* ANDAs since the commencement of the filing process in FY 2003-04. (*as of 30th September 2023) ###

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