DIPHARMA SA
Overview
DIPHARMA SA is an active pharmaceutical ingredient (API) supplier with 6 active FDA Type II Drug Master Files, covering CARGLUMIC ACID; MIGALASTAT HYDROCHLORIDE; MIGLUSTAT; NITISINONE; SAPROPTERIN DIHYDROCHLORIDE; SAPROPTERIN DIHYDROCHLORIDE (NEW PROCESS).
Core services & business areas
Active pharmaceutical ingredients supplied
Substances DIPHARMA SA is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
API / Drug Master Files
DIPHARMA SA 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.
- MIGALASTAT HYDROCHLORIDEActive2025-07-29
- CARGLUMIC ACIDActive2024-02-06
- NITISINONEActive2021-07-31
- SAPROPTERIN DIHYDROCHLORIDE (NEW PROCESS)Active2020-06-17
- MIGLUSTATActive2015-06-09
- SAPROPTERIN DIHYDROCHLORIDEActive2012-12-06
FDA compliance signals
No FDA recalls, Warning Letters, or Form 483 observations are linked to DIPHARMA SA in our records. PharmaTek screens the full directory against live FDA enforcement data.
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