GMT FINE CHEMICALS SA

Overview

GMT FINE CHEMICALS SA is an active pharmaceutical ingredient (API) supplier with 2 active FDA Type II Drug Master Files, covering LEUCOVORIN CALCIUM; LEVOLEUCOVORIN CALCIUM.

API / Drug Master Files

GMT FINE CHEMICALS SA holds 2 active (2 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.

• LEUCOVORIN CALCIUMActive2019-05-18
• LEVOLEUCOVORIN CALCIUMActive2011-08-10

FDA compliance signals

No FDA recalls, Warning Letters, or Form 483 observations are linked to GMT FINE CHEMICALS SA in our records. PharmaTek screens the full directory against live FDA enforcement data.