Jiangsu Alphamab Biopharmaceuticals Co., Ltd.

Overview

Jiangsu Alphamab Biopharmaceuticals Co., Ltd. is a leading clinical-stage biopharmaceutical company focused on the development and commercialization of innovative and affordable therapeutic biologics for cancer treatment. The company utilizes its proprietary technologies for the development of advanced antibodies and has a strong emphasis on research and development.

Therapeutic areas

API / Drug Master Files

Jiangsu Alphamab Biopharmaceuticals Co., Ltd. holds 3 active (3 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.

• DABIGATRAN INTERMEDIATE (DB-7-2)Active2022-01-13
• ROSUVASTATIN CALCIUM INTERMEDIATE (R1)Active2021-05-28
• ATROVASTATIN CALCIUM INTERMEDIATE (L1)Active2019-07-05

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to Jiangsu Alphamab Biopharmaceuticals Co., Ltd. in our records. PharmaTek screens the full directory against live FDA enforcement data.