Suppliers / Changzhou Qianhong Bio Pharma

Changzhou Qianhong Bio Pharma

China 88 employees Updated 9 July 2026

Changzhou Qianhong Bio Pharma is an API manufacturer based in China. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by MFDS (Korea), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 31 October 2025 as VAI.

2
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
2
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 31 October 2025 VAI US FDA
  • 10 May 2023 VAI US FDA
  • 23 October 2019 NAI US FDA
  • 15 December 2017 VAI US FDA
  • 1 August 2014 VAI US FDA
  • 30 April 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Changzhou, China Not on file
China, China 3005275502

What they file, and where

Molecule Regulators Docs
Dalteparin US FDA 1
Heparin Sodium US FDA 1

Also appears on these molecule pages

Heparin API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 2 None
MFDS (Korea) None 2
EMA None 1
US FDA None 1

Questions about Changzhou Qianhong Bio Pharma

Does Changzhou Qianhong Bio Pharma hold a US DMF or a CEP?
Changzhou Qianhong Bio Pharma holds 2 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 Changzhou Qianhong Bio Pharma FDA-registered?
One site operated by Changzhou Qianhong Bio Pharma 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 Changzhou Qianhong Bio Pharma's last inspection go?
The most recent inspection on record closed on 31 October 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Changzhou Qianhong Bio Pharma manufacture?
2 registered sites are on record, in China (Changzhou and China). Every site is listed on this page with the register it came from.
What does Changzhou Qianhong Bio Pharma make?
2 molecules are on record against Changzhou Qianhong Bio Pharma, including Dalteparin and Heparin Sodium. Each links through to that molecule's full manufacturer list.
Which regulators recognise Changzhou Qianhong Bio Pharma's GMP?
Current GMP certificates are on record from MFDS (Korea), 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 VAI, on 31 October 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