Suppliers / : Zhejiang Kangle Pharmaceutical

: Zhejiang Kangle Pharmaceutical

China Updated 9 July 2026

: Zhejiang Kangle Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its filings concentrate with INVIMA (CO) and NAFDAC (NG). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 14 March 2025 as NAI.

2
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
2
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

  • 14 March 2025 NAI US FDA
  • 22 March 2019 VAI US FDA
  • 22 July 2016 VAI US FDA
  • 20 December 2013 NAI US FDA
  • 23 April 2009 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 3010728912

What they file, and where

Molecule Regulators Docs
Acetaminophen SFDA (Saudi Arabia), US FDA 3
Acetaminophen Dc90% SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Paracetamol API Prednisolone finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
INVIMA (CO) 1 None
NAFDAC (NG) 1 None
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 14 March 2025.

Sources on this page

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