Zydus Lifesciences Ltd on Thursday (December 14) said it has secured final approval from the United States Food and Drug Administration (USFDA) for its Cyclophosphamide Capsules USP, available in 25 mg and 50 mg variants.
"Cyclophosphamide is a chemotherapy medication that slows the growth of cancer cells. It treats lymphoma, myeloma, leukaemia, breast cancer, and ovarian cancer," Zydus Lifesciences said in a regulatory filing
The approved capsules, equivalent to the US Reference Listed Drug (USRLD): Cyclophosphamide Capsules, 25 mg, and 50 mg, are poised to offer effective therapeutic solutions for a spectrum of cancers, including lymphoma, myeloma, leukaemia, breast cancer, and ovarian cancer.
The formulations will be produced at Zydus Lifesciences' state-of-the-art manufacturing facility situated in Ahmedabad SEZ, India. The company has notched up 383 approvals from the FDA.
Notably, Zydus Lifesciences has been a frontrunner in the Abbreviated New Drug Application (ANDA) filings, amassing over 448 submissions since the initiation of the process in the fiscal year 2003-04. Cyclophosphamide Capsules, with an annual sales record of $6 million in the United States as of October 2023.
The Ahmedabad-headquartered pharma major manufactures and markets a broad range of active pharmaceutical ingredients (API) and formulations.
The Zydus group has research facilities across Gujarat, Maharashtra, Goa, Himachal Pradesh, and Sikkim. It also has manufacturing and research units in the US and Brazil. The company operates outside India with licensing agreements with global multinationals.
Shares of Zydus Lifesciences Ltd ended at ₹646.20, up by ₹4.40, or 0.69%, on the BSE.
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