Suppliers / Zhejiang Apeloa Kangyu Pharmaceutical

Zhejiang Apeloa Kangyu Pharmaceutical

China Updated 9 July 2026

Zhejiang Apeloa Kangyu Pharmaceutical is an API manufacturer based in China. It holds 7 active US drug master files and 5 valid CEPs across a filed portfolio of 9 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 28 July 2023 as NAI.

7
active US DMFs
5
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
5 of 5 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 28 July 2023 NAI US FDA
  • 7 December 2018 VAI US FDA
  • 15 December 2016 VAI US FDA
  • 23 May 2014 VAI US FDA
  • 1 July 2010 NAI US FDA

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

Registered plants

Site FDA FEI
Hengdian, China Not on file
Jinhua, China Not on file
China, China 3003744129

What they file, and where

Molecule Regulators Docs
Levofloxacin EDQM, SFDA (Saudi Arabia), US FDA 3
Dextromethorphan EDQM, US FDA 2
Pseudoephedrine EDQM, US FDA 2
Amantadine US FDA 1
Diphenhydramine US FDA 1
Lovastatin US FDA 1
Marbofloxacin For Veterinary Use EDQM 1
Ofloxacin EDQM 1
Triclosan US FDA 1

Also appears on these molecule pages

Amantadine API Dextromethorphan API Diphenhydramine API Levofloxacin API Lovastatin API Marbofloxacin For Veterinary Use API Ofloxacin API Pseudoephedrine API Triclosan API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Zhejiang Apeloa Kangyu Pharmaceutical

Does Zhejiang Apeloa Kangyu Pharmaceutical hold a US DMF or a CEP?
Zhejiang Apeloa Kangyu Pharmaceutical holds 7 active US drug master files and 5 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 Kangyu Pharmaceutical FDA-registered?
One site operated by Zhejiang Apeloa Kangyu 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 Kangyu Pharmaceutical's last inspection go?
The most recent inspection on record closed on 28 July 2023 as NAI (No Action Indicated: nothing objectionable was found). 5 inspections are on file.
Where does Zhejiang Apeloa Kangyu Pharmaceutical manufacture?
3 registered sites are on record, in China (Hengdian, Jinhua and China). Every site is listed on this page with the register it came from.
What does Zhejiang Apeloa Kangyu Pharmaceutical make?
9 molecules are on record against Zhejiang Apeloa Kangyu Pharmaceutical, including Levofloxacin, Dextromethorphan, Pseudoephedrine and Amantadine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Apeloa Kangyu 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 28 July 2023.

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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