ScinoPharm Taiwan obtains Bortezomib for Injection ANDA approval

ScinoPharm Taiwan obtains Bortezomib for Injection ANDA approval

2023/10/2

Bortezomib for Injection developed and produced by ScinoPharm Taiwan, received the U.S. abbreviated new drug application (ANDA) approval on September 26, 2023. The Company systematically invests and strengthens its development and manufacturing capacities of injection products. Bortezomib Injection is our first injection product developed and manufactured by ScinoPharm Taiwan. By getting this ANDA approval, The Company has shown the capability of developing and manufacturing in-house injectable products. It is also a milestone for us to strengthen the vertical integration of the Company's business. 

ScinoPharm's pre-filled syringe and liquid injectable products, and lyophilized injectables passed the FDA's pre-approval on-site inspections in March and October 2022. ScinoPharm even achieved an outstanding result of zero 483 observations in the second inspection. In addition to ScinoPharm's APIs and injection products, contract development and manufacturing is its business's mainstay. Scinopharm will diversify business fields according to our business partner's timeline and explore more potential opportunities in different target markets.