Suppliers / Sigmapharm Laboratories

Sigmapharm Laboratories

United States 75 employees Updated 9 July 2026

Sigmapharm Laboratories is an API and finished-dose manufacturer based in United States. It holds 3 active US drug master files across a filed portfolio of 3 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 December 2025 as VAI.

3
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
27
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 17 December 2025 VAI US FDA
  • 13 February 2023 NAI US FDA
  • 7 December 2021 NAI US FDA
  • 13 June 2018 NAI US FDA
  • 19 June 2017 VAI US FDA
  • 23 June 2015 NAI US FDA
  • 19 November 2014 VAI US FDA
  • 20 March 2014 VAI US FDA

NAI means no action indicated, VAI means voluntary action indicated, and OAI means official action indicated.

Registered plants

Site FDA FEI
Bensalem, United States 3005444934

What they file, and where

Molecule Regulators Docs
Apixaban US FDA 1
Asenapine US FDA 1
Vortioxetine US FDA 1

Also appears on these molecule pages

Ambrisentan finished dose Asenapine API Dofetilide finished dose Flucytosine finished dose Vortioxetine API Apixaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 27 1

Questions about Sigmapharm Laboratories

Does Sigmapharm Laboratories hold a US DMF or a CEP?
Sigmapharm Laboratories holds 3 active US drug master files. A drug master file is a submission to the FDA describing how an ingredient is made; a CEP is the EDQM's certificate that the substance meets its European Pharmacopoeia monograph. Both are filings rather than approvals.
Is Sigmapharm Laboratories FDA-registered?
One site operated by Sigmapharm Laboratories carries an FDA establishment identifier (FEI), which means it is registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Sigmapharm Laboratories's last inspection go?
The most recent inspection on record closed on 17 December 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 8 inspections are on file.
Where does Sigmapharm Laboratories manufacture?
1 registered site is on record, in United States (Bensalem). Every site is listed on this page with the register it came from.
What does Sigmapharm Laboratories make?
3 molecules are on record against Sigmapharm Laboratories, including Apixaban, Asenapine and Vortioxetine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Sigmapharm Laboratories's GMP?
Current GMP certificates are on record from US FDA. GMP recognition covers the manufacturing site, separately from any filing on the substance itself.

Answered from this company's own record. Where a register holds nothing, the question is not asked rather than answered with a zero. How we count our figures.

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Open risk flags

  • 18 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 17 December 2025.

Comparable suppliers

Alembic Pharmaceuticals shares 2 molecules Matrix Pharmacorp shares 2 molecules Megafine Pharma (P) shares 2 molecules Hetero shares 1 molecule Cipla shares 1 molecule

Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates