Zydus receives final approval from USFDA for Bortezomib for Injection

Zydus Lifesciences Ltd today announced that it has received final approval from the United States Food and Drug Administration (USFDA) to market Bortezomib for Injection, 3.5 mg/vial, Single-Dose Vial (USRLD: Velcade).

Bortezomib for Injection is used to treat certain types of cancer such as multiple myeloma and mantle cell lymphoma. The medication works by slowing or stopping the growth of cancer cells. The drug will be manufactured at Zydus Hospira. Velcade has a market size of USD 1,172mn (as per IQVIA MAT March 2022).

The group now has 331 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Ltd formerly known as Cadila Healthcare Ltd. is an Indian multinational pharmaceutical company headquartered in Ahmedabad. It is primarily engaged in the manufacture of generic drugs and ranks 4th in the Indian pharmaceutical industry. The group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and the US and Brazil.

Zydus' global business has a strong presence in the regulated markets of the US, Europe (France and Spain) and the high-profile markets of Latin America and South Africa. It is also present in a big way in 25 other emerging markets worldwide.