Suppliers / Hebei Shengxue Dacheng Pharmaceutical

Hebei Shengxue Dacheng Pharmaceutical

China Updated 9 July 2026

Hebei Shengxue Dacheng Pharmaceutical is an API and finished-dose 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 EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 5 April 2024 as VAI.

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

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

Registered plants

Site FDA FEI
Tangshan, China Not on file
China, China 3005851696

What they file, and where

Molecule Regulators Docs
Colistimethate US FDA 1
Polymyxin B US FDA 1

Also appears on these molecule pages

Oxytetracycline finished dose Polymyxin B API

Filings and GMP by regulator

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

Questions about Hebei Shengxue Dacheng Pharmaceutical

Does Hebei Shengxue Dacheng Pharmaceutical hold a US DMF or a CEP?
Hebei Shengxue Dacheng Pharmaceutical 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 Hebei Shengxue Dacheng Pharmaceutical FDA-registered?
One site operated by Hebei Shengxue Dacheng 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 Shengxue Dacheng Pharmaceutical's last inspection go?
The most recent inspection on record closed on 5 April 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Hebei Shengxue Dacheng Pharmaceutical manufacture?
2 registered sites are on record, in China (Tangshan and China). Every site is listed on this page with the register it came from.
What does Hebei Shengxue Dacheng Pharmaceutical make?
2 molecules are on record against Hebei Shengxue Dacheng Pharmaceutical, including Colistimethate and Polymyxin B. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hebei Shengxue Dacheng 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.

Comparing suppliers?

Choose your molecules and target markets. Hebei Shengxue Dacheng 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 VAI, on 5 April 2024.

Comparable suppliers

Livzon Group Fuzhou Fuxing Pharmaceutical shares 1 molecule Xellia Pharmaceuticals shares 1 molecule Hangzhou Zhongmei Huadong Pharmaceutical shares 1 molecule Chengdu Yacht Biotechnology shares 1 molecule Biotika shares 1 molecule

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