TRANSGEN BIOTECH CO LTD

Overview

TRANSGEN BIOTECH CO LTD is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering ARTMEDIA® HUMAN T CELL SERUM-FREE MEDIUM; TRANSSTEM® CHEMICALLY DEFINED XENO-FREE CELL CRYOPRESERVATION MEDIUM III—DMSO FREE, PROTEIN FREE; UNIVERSAL NUCLEASE.

API / Drug Master Files

TRANSGEN BIOTECH 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.

• TRANSSTEM® CHEMICALLY DEFINED XENO-FREE CELL CRYOPRESERVATION MEDIUM III—DMSO FREE, PROTEIN FREEActive2024-12-31
• ARTMEDIA® HUMAN T CELL SERUM-FREE MEDIUMActive2024-09-23
• UNIVERSAL NUCLEASEActive2023-08-17

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to TRANSGEN BIOTECH CO LTD in our records. PharmaTek screens the full directory against live FDA enforcement data.