ASCENSUS SPECIALTIES LLC

Overview

ASCENSUS SPECIALTIES LLC is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering DEXMEDETOMIDINE HYDROCHLORIDE USP; FOMEPIZOLE; MANGANESE SULFATE USP.

API / Drug Master Files

ASCENSUS SPECIALTIES LLC 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.

• FOMEPIZOLEActive2024-07-24
• DEXMEDETOMIDINE HYDROCHLORIDE USPActive2023-09-21
• MANGANESE SULFATE USPActive2023-08-03

FDA compliance signals

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