Lepu Biopharma Co., Ltd.

Overview

Lepu Biopharma Co., Ltd. is a public biopharmaceutical company headquartered in China, specializing in the development, production, and distribution of therapeutic products focusing on oncology and other critical care areas.

Therapeutic areas

API / Drug Master Files

Lepu Biopharma Co., Ltd. holds 2 active (2 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.

• ICOSAPENT ETHYLActive2022-06-07
• EPA ETHYL ESTER 70Active2013-03-04

FDA compliance signals

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