Suppliers / Zhejiang Apeloa Jiayuan Pharmaceutical

Zhejiang Apeloa Jiayuan Pharmaceutical

China Updated 9 July 2026

Zhejiang Apeloa Jiayuan Pharmaceutical is an API manufacturer based in China. It holds 22 active US drug master files and 7 valid CEPs across a filed portfolio of 19 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 11 April 2025 as NAI.

22
active US DMFs
7
valid CEPs
4
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
6 of 6 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 11 April 2025 NAI US FDA
  • 11 May 2018 NAI US FDA
  • 4 December 2015 VAI US FDA
  • 16 May 2014 VAI US FDA
  • 11 May 2012 VAI US FDA
  • 22 January 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
Dongyang, China Not on file
Hengdian, China Not on file
Dongyang City, China Not on file
China, China 3004944662

What they file, and where

Molecule Regulators Docs
Metoprolol EDQM, US FDA 4
Clopidogrel EDQM, US FDA 3
Bupropion US FDA 2
Irbesartan SFDA (Saudi Arabia), US FDA 2
Levetiracetam EDQM, US FDA 2
Quetiapine EDQM, US FDA 2
Sacubitril US FDA 2
Telmisartan SFDA (Saudi Arabia), US FDA 2
Venlafaxine EDQM, US FDA 2
Brivaracetam US FDA 1
Show all 19 molecules on file
Desvenlafaxine US FDA 1
Gabapentin US FDA 1
Iron Dextran US FDA 1
Laropiprant US FDA 1
Levosalbutamol US FDA 1
Metaxalone US FDA 1
Methocarbamol US FDA 1
Pregabalin US FDA 1
Sitagliptin US FDA 1

Also appears on these molecule pages

Brivaracetam API Bupropion API Clopidogrel API Desvenlafaxine API Gabapentin API Irbesartan API Levetiracetam API Levosalbutamol API Metaxalone API Methocarbamol API Metoprolol API Pregabalin API
Show 5 more molecule pages
Quetiapine API Sacubitril API Telmisartan API Venlafaxine API Sitagliptin API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Zhejiang Apeloa Jiayuan Pharmaceutical

Does Zhejiang Apeloa Jiayuan Pharmaceutical hold a US DMF or a CEP?
Zhejiang Apeloa Jiayuan Pharmaceutical holds 22 active US drug master files and 7 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 Apeloa Jiayuan Pharmaceutical FDA-registered?
One site operated by Zhejiang Apeloa Jiayuan 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 Apeloa Jiayuan Pharmaceutical's last inspection go?
The most recent inspection on record closed on 11 April 2025 as NAI (No Action Indicated: nothing objectionable was found). 6 inspections are on file.
Where does Zhejiang Apeloa Jiayuan Pharmaceutical manufacture?
4 registered sites are on record, in China (Dongyang, Hengdian and Dongyang City among others). Every site is listed on this page with the register it came from.
What does Zhejiang Apeloa Jiayuan Pharmaceutical make?
19 molecules are on record against Zhejiang Apeloa Jiayuan Pharmaceutical, including Metoprolol, Clopidogrel, Bupropion and Irbesartan. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Apeloa Jiayuan 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 NAI, on 11 April 2025.

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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