Suppliers / Ampac Fine Chemicals

Ampac Fine Chemicals

United States 471 employees Updated 9 July 2026

Ampac Fine Chemicals is an API and finished-dose manufacturer based in United States. It holds 9 active US drug master files and one valid CEP across a filed portfolio of 13 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 10 September 2025 as NAI.

9
active US DMFs
1
valid CEPs
3
registered plants 2 with an FDA FEI number
4
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
2 of 2 confirmed
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 10 September 2025 NAI US FDA
  • 10 September 2025 NAI US FDA
  • 31 January 2019 NAI US FDA
  • 17 October 2018 NAI US FDA
  • 8 November 2016 VAI US FDA
  • 23 January 2015 VAI US FDA
  • 13 December 2012 VAI US FDA
  • 20 April 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Rancho Cordova, United States Not on file
El Dorado Hills, United States 3013339335
RANCHO CORDOVA, United States 2918710

What they file, and where

Molecule Regulators Docs
Carmustine EDQM, US FDA 2
Brigatinib SFDA (Saudi Arabia) 1
Cyclophosphamide US FDA 1
Dexmethylphenidate US FDA 1
Levorphanol US FDA 1
Methylphenidate US FDA 1
Oseltamivir US FDA 1
Remifentanil US FDA 1
Ruxolitinib SFDA (Saudi Arabia) 1
Sofosbuvir SFDA (Saudi Arabia) 1
Show all 13 molecules on file
Sotorasib SFDA (Saudi Arabia) 1
Tapentadol US FDA 1
Temozolomide US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 4 None
US FDA None 2

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Open risk flags

  • The most recent inspection outcome was NAI, on 10 September 2025.

Sources on this page

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