Suppliers / Zhejiang Huayi Pharmaceutical

Zhejiang Huayi Pharmaceutical

China Updated 9 July 2026

Zhejiang Huayi Pharmaceutical is an API manufacturer based in China. It holds 10 active US drug master files and 4 valid CEPs across a filed portfolio of 13 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 18 April 2025 as VAI.

10
active US DMFs
4
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
Inspections
4 of 4 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 18 April 2025 VAI US FDA
  • 16 March 2018 VAI US FDA
  • 3 April 2015 VAI US FDA
  • 30 October 2010 VAI US FDA

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

Registered plants

Site FDA FEI
Yiwu, China Not on file
Jinhua, China Not on file
China, China 3003657871

What they file, and where

Molecule Regulators Docs
Mirabegron EDQM, US FDA 2
Apremilast US FDA 1
Canagliflozin US FDA 1
Ciprofloxacin US FDA 1
Clarithromycin EDQM 1
Empagliflozin US FDA 1
Ibrutinib US FDA 1
Levetiracetam EDQM 1
Macitentan US FDA 1
Omeprazole EDQM 1
Show all 13 molecules on file
Pioglitazone US FDA 1
Regorafenib US FDA 1
Selexipag US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 18 April 2025.

Sources on this page

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