Suppliers / Amphastar Nanjing

Amphastar Nanjing

China 1 employees reconciled across 9 public records · 7 entities Updated 9 July 2026

Amphastar Nanjing is an API manufacturer based in China. It holds 16 active US drug master files across a filed portfolio of 13 molecules. Its filings concentrate with US FDA, Health Canada and AIFA (IT). Its GMP standing is certified by ANSM (FR), US FDA and EMA. Its most recent recorded inspection, by US FDA, closed on 3 April 2025 as NAI.

16
active US DMFs
0
valid CEPs
5
registered plants 3 with an FDA FEI number
45
filings across 11 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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
  • 7 March 2025 NAI US FDA
  • 1 March 2024 VAI US FDA
  • 25 November 2022 VAI US FDA
  • 22 June 2021 NAI US FDA
  • 22 November 2019 NAI US FDA
  • 21 November 2019 NAI US FDA
  • 11 October 2019 VAI US FDA
  • 25 July 2019 NAI US FDA
  • 29 June 2018 VAI US FDA
  • 26 October 2017 NAI US FDA
  • 31 March 2017 VAI US FDA

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

Registered plants

Site FDA FEI
China, China 3009805706
ERAGNY SUR EPTE, France Not on file
Eragny Sur Epte, France Not on file
France, France 3003672088
Rancho Cucamonga, United States 3002936358

What they file, and where

Molecule Regulators Docs
Beclomethasone Dipropionate US FDA 1
Budesonide US FDA 1
Epinephrine US FDA 1
Fluticasone Propionate US FDA 1
Formoterol US FDA 1
Insulin Human US FDA 1
Ipratropium US FDA 1
Isoprenaline US FDA 1
Medroxyprogesterone Acetate US FDA 1
Phylloquinone US FDA 1
Show all 13 molecules on file
Protamine Sulfate US FDA 1
Salmeterol US FDA 1
Teriparatide US FDA 1

Also appears on these molecule pages

Beclomethasone API Budesonide API Epinephrine API Fluticasone API Formoterol API Ipratropium API Isoprenaline API Medroxyprogesterone API Phylloquinone API Salmeterol API Teriparatide API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 25 2
Health Canada 6 None
AIFA (IT) 3 None
FAMHP (BE) 2 None
DMP (NO) 2 None
EMA 2 2
ANSM (FR) None 29

Questions about Amphastar Nanjing

Does Amphastar Nanjing hold a US DMF or a CEP?
Amphastar Nanjing holds 16 active US drug master files. 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 Amphastar Nanjing FDA-registered?
3 sites operated by Amphastar Nanjing 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 Amphastar Nanjing's last inspection go?
The most recent inspection on record closed on 3 April 2025 as NAI (No Action Indicated: nothing objectionable was found). 24 inspections are on file.
Where does Amphastar Nanjing manufacture?
5 registered sites are on record, in China, France and United States (China, Eragny SUR Epte and Eragny Sur Epte among others). Every site is listed on this page with the register it came from.
What does Amphastar Nanjing make?
13 molecules are on record against Amphastar Nanjing, including Beclomethasone Dipropionate, Budesonide, Epinephrine and Fluticasone Propionate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Amphastar Nanjing's GMP?
Current GMP certificates are on record from ANSM (FR), US FDA and EMA. 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