Suppliers / Inner Mongolia Changsheng Pharmaceutical

Inner Mongolia Changsheng Pharmaceutical

China Updated 9 July 2026

Inner Mongolia Changsheng Pharmaceutical is an API manufacturer based in China. It holds 7 active US drug master files and 5 valid CEPs across a filed portfolio of 6 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 13 November 2024 as NAI.

7
active US DMFs
5
valid CEPs
3
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 13 November 2024 NAI US FDA
  • 26 June 2015 NAI US FDA
  • 26 October 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
Hohhot, China Not on file
Tuoketuo, China Not on file
China, China 3006272230

What they file, and where

Molecule Regulators Docs
Ampicillin EDQM, US FDA 5
Amoxicillin EDQM, US FDA 2
Benzylpenicillin EDQM, US FDA 2
Amoxicillin Trihydrate EDQM 1
Piperacillin US FDA 1
Sulbactam US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 13 November 2024.

Sources on this page

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