Overview
ICE SPA is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering CHENODEOXYCHOLIC ACID; TAUROURSODEOXYCHOLIC ACID; URSODIOL.
API / Drug Master Files
ICE SPA 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.
- CHENODEOXYCHOLIC ACIDActive2016-11-21
- TAUROURSODEOXYCHOLIC ACIDActive2016-09-30
- URSODIOLActive2003-09-03
FDA compliance signals
No FDA recalls, Warning Letters, or Form 483 observations are linked to ICE SPA in our records. PharmaTek screens the full directory against live FDA enforcement data.
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