SIGMAPHARM LABORATORIES LLC

Overview

SIGMAPHARM LABORATORIES LLC is an active pharmaceutical ingredient (API) supplier with 5 active FDA Type II Drug Master Files, covering AMORPHOUS ADEFOVIR DIPIVOXIL (11.6% COPOVIDONE DISPERSION); AMORPHOUS DOFETILIDE; APIXABAN AMORPHOUS (6.58%); ASENAPINE MALEATE AMORPHOUS (31.2%) PREMIX; VORTIOXETINE HYDROBROMIDE AMORPHOUS (24.12%).

API / Drug Master Files

SIGMAPHARM LABORATORIES LLC holds 5 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.

• VORTIOXETINE HYDROBROMIDE AMORPHOUS (24.12%)Active2017-08-16
• APIXABAN AMORPHOUS (6.58%)Active2016-08-10
• AMORPHOUS DOFETILIDEActive2014-06-05
• ASENAPINE MALEATE AMORPHOUS (31.2%) PREMIXActive2013-08-08
• AMORPHOUS ADEFOVIR DIPIVOXIL (11.6% COPOVIDONE DISPERSION)Active2010-06-03

FDA compliance signals

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