Suppliers / Hangzhou Zhongmei Huadong Pharmaceutical

Hangzhou Zhongmei Huadong Pharmaceutical

China 13 employees Updated 9 July 2026

Hangzhou Zhongmei Huadong Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 12 active US drug master files across a filed portfolio of 10 molecules. Its filings concentrate with US FDA and MINSA (CR). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 18 August 2023 as VAI.

12
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
6
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 18 August 2023 VAI US FDA
  • 23 August 2018 VAI US FDA
  • 28 July 2016 VAI US FDA
  • 2 May 2014 VAI US FDA
  • 17 May 2012 VAI US FDA

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

Registered plants

Site FDA FEI
China, China 3003995556

What they file, and where

Molecule Regulators Docs
Mupirocin SFDA (Saudi Arabia), US FDA 3
Fondaparinux US FDA 2
Daptomycin US FDA 1
Insulin Aspart US FDA 1
Insulin Degludec US FDA 1
Pantoprazole US FDA 1
Polymyxin B US FDA 1
Semaglutide US FDA 1
Tacrolimus US FDA 1
Voclosporin US FDA 1

Also appears on these molecule pages

Caspofungin finished dose Daptomycin API Fondaparinux API Mupirocin API Polymyxin B API Semaglutide API Tacrolimus API Voclosporin API Pantoprazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA 5 1
MINSA (CR) 1 None

Questions about Hangzhou Zhongmei Huadong Pharmaceutical

Does Hangzhou Zhongmei Huadong Pharmaceutical hold a US DMF or a CEP?
Hangzhou Zhongmei Huadong Pharmaceutical holds 12 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 Hangzhou Zhongmei Huadong Pharmaceutical FDA-registered?
One site operated by Hangzhou Zhongmei Huadong 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 Hangzhou Zhongmei Huadong Pharmaceutical's last inspection go?
The most recent inspection on record closed on 18 August 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Hangzhou Zhongmei Huadong Pharmaceutical manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does Hangzhou Zhongmei Huadong Pharmaceutical make?
10 molecules are on record against Hangzhou Zhongmei Huadong Pharmaceutical, including Mupirocin, Fondaparinux, Daptomycin and Insulin Aspart. Each links through to that molecule's full manufacturer list.
Which regulators recognise Hangzhou Zhongmei Huadong Pharmaceutical's GMP?
Current GMP certificates are on record from 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 18 August 2023.

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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