Suppliers / Hebei Changshan Biochemical Pharmaceutical

Hebei Changshan Biochemical Pharmaceutical

China Updated 9 July 2026

Hebei Changshan Biochemical Pharmaceutical is an API manufacturer based in China. It holds 2 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its filings concentrate with RCETH (BY) and UZPHARM (UZ). Its GMP standing is certified by UZPHARM (UZ), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 5 April 2024 as NAI.

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

  • 5 April 2024 NAI US FDA
  • 17 April 2015 NAI US FDA

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

Registered plants

Site FDA FEI
Shijiazhuang, China Not on file
China, China 3010849972

What they file, and where

Molecule Regulators Docs
Heparin Sodium EDQM, US FDA 2
Enoxaparin US FDA 1

Also appears on these molecule pages

Enoxaparin API Heparin API

Filings and GMP by regulator

Regulator Filings GMP certificates
RCETH (BY) 1 None
UZPHARM (UZ) 1 1
EMA None 1
US FDA None 1

Questions about Hebei Changshan Biochemical Pharmaceutical

Does Hebei Changshan Biochemical Pharmaceutical hold a US DMF or a CEP?
Hebei Changshan Biochemical Pharmaceutical holds 2 active US drug master files and 1 valid CEP. 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 Hebei Changshan Biochemical Pharmaceutical FDA-registered?
One site operated by Hebei Changshan Biochemical 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 Hebei Changshan Biochemical Pharmaceutical's last inspection go?
The most recent inspection on record closed on 5 April 2024 as NAI (No Action Indicated: nothing objectionable was found). 2 inspections are on file.
Where does Hebei Changshan Biochemical Pharmaceutical manufacture?
2 registered sites are on record, in China (Shijiazhuang and China). Every site is listed on this page with the register it came from.
What does Hebei Changshan Biochemical Pharmaceutical make?
2 molecules are on record against Hebei Changshan Biochemical Pharmaceutical, including Heparin Sodium and Enoxaparin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hebei Changshan Biochemical Pharmaceutical's GMP?
Current GMP certificates are on record from UZPHARM (UZ), 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.

Comparing suppliers?

Choose your molecules and target markets. Hebei Changshan Biochemical Pharmaceutical comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was NAI, on 5 April 2024.

Comparable suppliers

Gland Pharma shares 2 molecules Dongying Tiandong Pharmaceutical shares 2 molecules Hubei Enoray Biopharmaceutical shares 2 molecules Nanjing King-Friend Biochemical Pharmaceutical shares 2 molecules Yantai Dongcheng Biochemicals Co.,Ltd shares 2 molecules

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