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

Canagliflozin API Ciprofloxacin API Clarithromycin API Ibrutinib API Macitentan API Mirabegron API Pioglitazone API Regorafenib API Selexipag API Omeprazole API Empagliflozin API Levetiracetam API
Show 1 more molecule pages
Apremilast API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Zhejiang Huayi Pharmaceutical

Does Zhejiang Huayi Pharmaceutical hold a US DMF or a CEP?
Zhejiang Huayi Pharmaceutical holds 10 active US drug master files and 4 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 Huayi Pharmaceutical FDA-registered?
One site operated by Zhejiang Huayi 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 Zhejiang Huayi Pharmaceutical's last inspection go?
The most recent inspection on record closed on 18 April 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Zhejiang Huayi Pharmaceutical manufacture?
3 registered sites are on record, in China (Yiwu, Jinhua and China). Every site is listed on this page with the register it came from.
What does Zhejiang Huayi Pharmaceutical make?
13 molecules are on record against Zhejiang Huayi Pharmaceutical, including Mirabegron, Apremilast, Canagliflozin and Ciprofloxacin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Huayi 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.

Comparing suppliers?

Choose your molecules and target markets. Zhejiang Huayi Pharmaceutical comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

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

Comparable suppliers

Dr Reddy's Laboratories shares 5 molecules Alembic Pharmaceuticals shares 5 molecules MSN Laboratories shares 4 molecules Hetero shares 4 molecules Zydus Lifesciences shares 4 molecules

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