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

Amoxicillin API Ampicillin API Benzylpenicillin API Piperacillin API Sulbactam API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1
US FDA None 1

Questions about Inner Mongolia Changsheng Pharmaceutical

Does Inner Mongolia Changsheng Pharmaceutical hold a US DMF or a CEP?
Inner Mongolia Changsheng Pharmaceutical holds 7 active US drug master files and 5 valid CEPs. 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 Inner Mongolia Changsheng Pharmaceutical FDA-registered?
One site operated by Inner Mongolia Changsheng Pharmaceutical 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 Inner Mongolia Changsheng Pharmaceutical's last inspection go?
The most recent inspection on record closed on 13 November 2024 as NAI (No Action Indicated: nothing objectionable was found). 3 inspections are on file.
Where does Inner Mongolia Changsheng Pharmaceutical manufacture?
3 registered sites are on record, in China (Hohhot, Tuoketuo and China). Every site is listed on this page with the register it came from.
What does Inner Mongolia Changsheng Pharmaceutical make?
6 molecules are on record against Inner Mongolia Changsheng Pharmaceutical, including Ampicillin, Amoxicillin, Benzylpenicillin and Amoxicillin Trihydrate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Inner Mongolia Changsheng Pharmaceutical's GMP?
Current GMP certificates are on record from EMA and 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 13 November 2024.

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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