QUIMICA SINTETICA SA

Overview

QUIMICA SINTETICA SA is an active pharmaceutical ingredient (API) supplier with 41 active FDA Type II Drug Master Files, covering ACYCLOVIR; APREMILAST; APREMILAST (PROCESS II); BENZNIDAZOLE; CAPTOPRIL; CHLORAMPHENICOL.

API / Drug Master Files

QUIMICA SINTETICA SA holds 41 active (72 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.

• KETOROLACActive2025-12-19
• SPINOSADActive2024-07-30
• RIVAROXABANActive2024-01-29
• ELTROMBOPAG OLAMINEActive2023-05-02
• POSACONAZOLEActive2020-12-22
• APREMILAST (PROCESS II)Active2020-06-17
• EDARAVONEActive2020-05-12
• FOSFOMYCIN TROMETHAMINEActive2018-11-02
• DROXIDOPAActive2017-11-24
• APREMILASTActive2017-10-10
• LEVOMILNACIPRAN HYDROCHLORIDEActive2017-02-17
• BENZNIDAZOLEActive2016-06-27
• LANSOPRAZOLE (PROCESS II)Active2015-06-26
• LEVOFLOXACINActive2014-12-15
• RABEPRAZOLE SODIUM (PROCESS II)Active2011-09-20

Showing 15 of 72 Drug Master Files.

FDA compliance signals

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