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%).
Core services & business areas
Active pharmaceutical ingredients supplied
Substances SIGMAPHARM LABORATORIES LLC is evidenced to supply (US FDA Drug Master File or EU CEP). Open any ingredient to see its full supplier landscape, CAS number and patent status.
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
15 FDA enforcement records linked to this company.
- 4832025-12-17
Extent of discrepancy, failure investigations
- recall — Class II2021-10-06
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
- recall — Class II2021-09-01
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
- recall — Class III2021-05-26
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
- recall — Class III2021-05-26
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
- 4832017-06-19
Review of representative number of batches
- 4832014-11-19
Annual visual exams of drug products
- 4832014-11-19
Control procedures to monitor and validate performance
- 4832014-11-19
Acceptance criteria for sampling & testing
- 4832014-11-19
Cleaning / Sanitizing / Maintenance
- 4832014-11-19
Approve or reject procedures or specs
- 4832014-11-19
Maintenance of Complaint File
- recall — Class II2014-05-28
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
- 4832013-08-13
Failure to review ADE information
- 4832013-08-13
Incomplete periodic safety report
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