Zydus Lifesciences Ltd with its subsidiaries received final approval from the United States Food and Drug Administration (USFDA) for Cyclophosphamide Capsules USP in 25 mg and 50 mg formulations.
Cyclophosphamide, a chemotherapy medication known for slowing the growth of cancer cells, is effective in treating various cancers such as lymphoma, myeloma, leukemia, breast cancer, and ovarian cancer. The approved drug will be manufactured at Zydus’ formulation manufacturing facility located in Ahmedabad SEZ, India.
The annual sales of Cyclophosphamide Capsules USP, 25 mg and 50 mg, in the United States were reported to be $6 million as of October 2023. The company reported that with this approval, Zydus expanded its oncology medication portfolio, contributing to its growing list of 383 approvals and over 448 ANDAs filed.
The shares were up by 0.93 per cent to ₹643.00 at 2:26 pm on the BSE.