NORTEC QUIMICA SA

Overview

NORTEC QUIMICA SA is an active pharmaceutical ingredient (API) supplier with 4 active FDA Type II Drug Master Files, covering BUPIVACAINE; ESKETAMINE HYDROCHLORIDE; PRILOCAINE; SPIRONOLACTONE.

API / Drug Master Files

NORTEC QUIMICA SA holds 4 active (4 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.

• SPIRONOLACTONEActive2024-06-06
• ESKETAMINE HYDROCHLORIDEActive2022-12-09
• BUPIVACAINEActive2018-11-21
• PRILOCAINEActive2017-12-07

FDA compliance signals

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