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.
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
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
Also appears on these molecule pages
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 27 | 1 |
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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.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates