Suppliers / Zhejiang Zhenyuan Pharmaceutical

Zhejiang Zhenyuan Pharmaceutical

China Updated 9 July 2026

Zhejiang Zhenyuan Pharmaceutical is an API manufacturer based in China. It holds one valid CEP. Its GMP standing is certified by EMA and MFDS (Korea).

0
active US DMFs
1
valid CEPs
3
registered plants
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
EU GMP
1 of 1 confirmed
Sources: EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Registered plants

Site FDA FEI
Yuecheng, China Not on file
Shaoxing City, China Not on file
Shaoxing, China Not on file

What they file, and where

Molecule Regulators Docs
Netilmicin EDQM 1

Filings and GMP by regulator

Regulator Filings GMP certificates
UZPHARM (UZ) 1 None
EMA None 2
MFDS (Korea) None 2

Questions about Zhejiang Zhenyuan Pharmaceutical

Does Zhejiang Zhenyuan Pharmaceutical hold a US DMF or a CEP?
Zhejiang Zhenyuan Pharmaceutical holds 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.
Where does Zhejiang Zhenyuan Pharmaceutical manufacture?
3 registered sites are on record, in China (Yuecheng, Shaoxing City and Shaoxing). Every site is listed on this page with the register it came from.
What does Zhejiang Zhenyuan Pharmaceutical make?
1 molecule is on record against Zhejiang Zhenyuan Pharmaceutical, including Netilmicin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Zhenyuan Pharmaceutical's GMP?
Current GMP certificates are on record from EMA and MFDS (Korea). 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