Suppliers / Zhejiang Medicine

Zhejiang Medicine

China reconciled across 30 public records · 4 entities Updated 9 July 2026

Zhejiang Medicine is an API manufacturer based in China. It holds 9 active US drug master files and 8 valid CEPs across a filed portfolio of 10 molecules. Its filings concentrate with DIGEMAPS (DO) and NMPA (CN). Its GMP standing is certified by MFDS (Korea), MHRA (UK) and US FDA. Its most recent recorded inspection, by US FDA, closed on 7 March 2025 as VAI.

9
active US DMFs
8
valid CEPs
4
registered plants 1 with an FDA FEI number
16
filings across 2 regulators

Inspection history

  • 7 March 2025 VAI US FDA
  • 30 November 2018 VAI US FDA
  • 30 June 2017 VAI US FDA
  • 18 June 2015 OAI US FDA
  • 17 January 2013 NAI US FDA
  • 16 April 2010 VAI US FDA
  • 11 March 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Xinchang, China Not on file
Shaoxing, China Not on file
XINCHANG, China Not on file
China, China 3003631275

What they file, and where

Molecule Regulators Docs
Vancomycin Hydrochloride EDQM 8
Teicoplanin EDQM, SFDA (Saudi Arabia) 6
Levofloxacin EDQM, SFDA (Saudi Arabia), US FDA 5
Daptomycin SFDA (Saudi Arabia), US FDA 3
Minocycline EDQM, US FDA 3
Vancomycin SFDA (Saudi Arabia), US FDA 3
Bosentan US FDA 1
Icosapent Ethyl US FDA 1
Miglitol US FDA 1
Rifaximin US FDA 1

Also appears on these molecule pages

Daptomycin API Minocycline API Teicoplanin API Vancomycin API Levofloxacin API

Filings and GMP by regulator

Regulator Filings GMP certificates
DIGEMAPS (DO) 18 None
NMPA (CN) 14 None
MFDS (Korea) None 2
MHRA (UK) None 1
US FDA None 1

Questions about Zhejiang Medicine

Does Zhejiang Medicine hold a US DMF or a CEP?
Zhejiang Medicine holds 9 active US drug master files and 8 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 Zhejiang Medicine FDA-registered?
One site operated by Zhejiang Medicine 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 Zhejiang Medicine's last inspection go?
The most recent inspection on record closed on 7 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 7 inspections are on file, of which 1 closed as OAI.
Where does Zhejiang Medicine manufacture?
4 registered sites are on record, in China (Xinchang, Shaoxing and Xinchang among others). Every site is listed on this page with the register it came from.
What does Zhejiang Medicine make?
10 molecules are on record against Zhejiang Medicine, including Vancomycin Hydrochloride, Teicoplanin, Levofloxacin and Daptomycin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Medicine's GMP?
Current GMP certificates are on record from MFDS (Korea), MHRA (UK) 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 7 March 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