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 7 active (7 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.
- SYNTECAN TActive2026-05-20
- 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.
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