Zydus Receives Final Approval From The USFDA For Cyclophosphamide Capsules USP

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), the company on Thursday announced through an exchange filing.

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 US Dollar 6 million in the United States (IQVIA MAT October,2023).

The group now has 383 approvals and has so far filed over 448* ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Limited shares

The shares of Zydus Lifesciences Limited on Thursday at 3:30 pm IST closed at Rs 646, up by 0.56 per cent.

Published on: Thursday, December 14, 2023, 03:53 PM IST