SYNAFFIX BV

Overview

SYNAFFIX BV is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering ENDOGLYCOSIDASE SH (ENDOSH); GLYCOSYLTRANSFERASE (GT); SYNEAMICIN G; SYNSTATIN E; SYNTECAN E; UDP-AZIDOSUGAR.

API / Drug Master Files

SYNAFFIX BV holds 6 active (6 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.

• SYNSTATIN EActive2025-05-08
• SYNEAMICIN GActive2025-02-26
• GLYCOSYLTRANSFERASE (GT)Active2024-09-12
• UDP-AZIDOSUGARActive2024-08-30
• ENDOGLYCOSIDASE SH (ENDOSH)Active2024-06-27
• SYNTECAN EActive2023-07-27

FDA compliance signals

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