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

Acalabrutinib finished dose Carmustine API Cyclophosphamide API Dexmethylphenidate API Methylphenidate API Oseltamivir API Remifentanil API Ruxolitinib API Sofosbuvir API Tapentadol API Temozolomide API

Filings and GMP by regulator

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

Questions about Ampac Fine Chemicals

Does Ampac Fine Chemicals hold a US DMF or a CEP?
Ampac Fine Chemicals holds 9 active US drug master files and 1 valid CEP. 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 Ampac Fine Chemicals FDA-registered?
2 sites operated by Ampac Fine Chemicals carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Ampac Fine Chemicals's last inspection go?
The most recent inspection on record closed on 10 September 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Ampac Fine Chemicals manufacture?
3 registered sites are on record, in United States (Rancho Cordova, El Dorado Hills and Rancho Cordova). Every site is listed on this page with the register it came from.
What does Ampac Fine Chemicals make?
13 molecules are on record against Ampac Fine Chemicals, including Carmustine, Brigatinib, Cyclophosphamide and Dexmethylphenidate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Ampac Fine Chemicals'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

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

Comparable suppliers

MSN Laboratories shares 3 molecules Hetero shares 3 molecules Cipla shares 3 molecules Laurus Labs shares 3 molecules Veranova Lp shares 3 molecules

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