HUAYI ISOTOPES CO

Overview

HUAYI ISOTOPES CO is an active pharmaceutical ingredient (API) supplier with 3 active FDA Type II Drug Master Files, covering 18F-FDG REAGENT KITS; MANNOSE TRIFLATE; OXYGEN-18 WATER.

API / Drug Master Files

HUAYI ISOTOPES CO holds 3 active (5 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.

• 18F-FDG REAGENT KITSActive2016-01-18
• OXYGEN-18 WATERActive2011-10-10
• MANNOSE TRIFLATEActive2007-11-16
• RK-100Inactive2011-10-19
• NON-PRODUCT SPECIFIC DOCUMENTATION FOR STERILIZATION PROCESS VALIDATION APPLICATIONS FOR HUMAN AND VETERINARY DRUG PRODUCTSInactive2009-01-16

FDA compliance signals

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