Zydus receives final approval from USFDA for Cyclophosphamide Capsules USP
New Delhi: Zydus Lifesciences Limited (including its subsidiaries/associates, hereinafter referred to as Zydus) has received approval from the United States Food and Drug Administration for Cyclophosphamide Capsules USP, 25 mg and 50 mg (USRLD: Cyclophosphamide Capsules, 25 mg and Final approval has been received from USFDA. 50 mg), the company announced through an exchange filing on Thursday.
Cyclophosphamide is a chemotherapy drug 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 in Ahmedabad SEZ, India. Cyclophosphamide Capsules USP, 25 mg and 50 mg had annual sales in the United States of US$6 million (IQVIA MAT October, 2023).
The Group now has 383 approvals and has filed 448* ANDAs so far since the filing process began in FY 2003-04.
Shares of Zydus Lifesciences Limited
Shares of Zydus Lifesciences Ltd closed at Rs 646, up 0.56 per cent, at 3:30 PM IST on Thursday.
