Suppliers / Dzd (Heze) Pharmaceutical

Dzd (Heze) Pharmaceutical

China Updated 9 July 2026

Dzd (Heze) Pharmaceutical is an API manufacturer based in China. It holds 4 active US drug master files and 3 valid CEPs across a filed portfolio of 4 molecules. Its GMP standing is certified by EMA.

4
active US DMFs
3
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
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Heze City, China Not on file
Heze, China Not on file
China, China 3012104330

What they file, and where

Molecule Regulators Docs
Doxorubicin EDQM, SFDA (Saudi Arabia), US FDA 3
Daunorubicin EDQM, US FDA 2
Epirubicin EDQM, US FDA 2
Valrubicin US FDA 1

Also appears on these molecule pages

Daunorubicin API Doxorubicin API Epirubicin API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1

Questions about Dzd (Heze) Pharmaceutical

Does Dzd (Heze) Pharmaceutical hold a US DMF or a CEP?
Dzd (Heze) Pharmaceutical holds 4 active US drug master files and 3 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 Dzd (Heze) Pharmaceutical FDA-registered?
One site operated by Dzd (Heze) 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.
Where does Dzd (Heze) Pharmaceutical manufacture?
3 registered sites are on record, in China (Heze City, Heze and China). Every site is listed on this page with the register it came from.
What does Dzd (Heze) Pharmaceutical make?
4 molecules are on record against Dzd (Heze) Pharmaceutical, including Doxorubicin, Daunorubicin, Epirubicin and Valrubicin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Dzd (Heze) Pharmaceutical's GMP?
Current GMP certificates are on record from EMA. 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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Sources on this page

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