Zydus Lifesciences gains FDA approval for Cyclophosphamide Capsules

Zydus Lifesciences Limited, a leading pharmaceutical company, has achieved a significant milestone by receiving final approval from the United States Food and Drug Administration (USFDA) for its Cyclophosphamide Capsules USP, available in 25 mg and 50 mg dosages. This approval represents a major advancement in the field of oncology, as Cyclophosphamide is a key chemotherapy medication used in the treatment of various cancers including lymphoma, myeloma, leukemia, breast cancer, and ovarian cancer.

The approved drug, which is equivalent to Cyclophosphamide Capsules in both 25 mg and 50 mg, will be manufactured at Zydus’ state-of-the-art formulation manufacturing facility located in the Ahmedabad Special Economic Zone (SEZ) in India. This facility is known for its cutting-edge technology and adherence to global quality standards, ensuring the highest level of efficacy and safety for the medications produced.

FDA Approves Zydus Lifesciences’ Cyclophosphamide for Cancer Therapy

According to the latest data from IQVIA MAT (as of October 2023), Cyclophosphamide Capsules USP, 25 mg and 50 mg, have recorded annual sales of USD 6 million in the United States. This approval not only enhances Zydus’ portfolio but also underscores the company’s commitment to providing effective treatment options for life-threatening illnesses.

Zydus Lifesciences Limited, a subsidiary of the renowned Zydus Group, has a robust track record in the pharmaceutical industry. With this latest USFDA approval, the group now boasts 383 approvals, underlining its extensive experience and expertise in drug development and regulatory compliance. Since the beginning of its filing process in the financial year 2003-04, Zydus has filed over 448 Abbreviated New Drug Applications (ANDAs), reflecting its sustained focus on research and development in the pharmaceutical sector.

This latest development is a testament to Zydus Lifesciences Limited’s dedication to advancing healthcare solutions and making a significant impact in the realm of cancer treatment. The approval of Cyclophosphamide Capsules by the USFDA marks a pivotal step for Zydus in reinforcing its position as a leader in the global pharmaceutical industry, particularly in the oncology segment. It highlights the company’s ongoing efforts to innovate and deliver life-saving treatments to patients across the globe.