Suppliers / Amphastar Pharmaceuticals

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.

0
active US DMFs
0
valid CEPs
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
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

  • 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

Questions about Amphastar Pharmaceuticals

Does Amphastar Pharmaceuticals hold a US DMF or a CEP?
No active US drug master file or valid CEP is on record for Amphastar Pharmaceuticals. It does have 19 filings with one regulator, so it is registered, just not with the two strong registers buyers usually screen on.
Is Amphastar Pharmaceuticals FDA-registered?
One site operated by Amphastar Pharmaceuticals 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 Amphastar Pharmaceuticals's last inspection go?
The most recent inspection on record closed on 3 April 2025 as NAI (No Action Indicated: nothing objectionable was found). 8 inspections are on file.
Where does Amphastar Pharmaceuticals manufacture?
1 registered site is on record, in United States (Rancho Cucamonga). Every site is listed on this page with the register it came from.
Which regulators recognise Amphastar Pharmaceuticals'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 3 April 2025.

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Sources on this page

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