Amphastar Pharmaceuticals
United States 416 employees Updated 9 July 2026
The public registers hold a second record for Amphastar Pharmaceuticals. The fuller profile,
with 16 active US DMFs and 0 valid CEPs, is at Amphastar Nanjing.
Figures on this page cover only this record.
Amphastar Pharmaceuticals is a finished-dose manufacturer based in United States. It appears in 19 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 3 April 2025 as NAI.
1
registered plants
1 with an FDA FEI number
19
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
- 3 April 2025 NAI US FDA
- 1 March 2024 VAI US FDA
- 22 June 2021 NAI US FDA
- 22 November 2019 NAI US FDA
- 21 November 2019 NAI US FDA
- 25 July 2019 NAI US FDA
- 31 March 2017 VAI US FDA
- 8 August 2014 NAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| Rancho Cucamonga, United States | 3002936358 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| US FDA | 19 | 1 |
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Open risk flags
- The most recent inspection outcome was NAI, on 3 April 2025.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates