Suppliers / Zhejiang Langhua Pharmaceutical

Zhejiang Langhua Pharmaceutical

China Updated 9 July 2026

Zhejiang Langhua Pharmaceutical is a contract manufacturer based in China. It holds 3 active US drug master files and 3 valid CEPs across a filed portfolio of 5 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 August 2024 as VAI.

3
active US DMFs
3
valid CEPs
2
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

  • 30 August 2024 VAI US FDA
  • 23 March 2018 NAI US FDA
  • 21 November 2014 VAI US FDA
  • 1 March 2012 VAI US FDA

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

Registered plants

Site FDA FEI
Linhai, China Not on file
China, China 3005289386

What they file, and where

Molecule Regulators Docs
Levofloxacin EDQM, US FDA 2
Spironolactone EDQM, US FDA 2
Empagliflozin US FDA 1
Enrofloxacin For Veterinary Use EDQM 1
Ibrutinib SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Ciprofloxacin contract manufacturing Dolutegravir contract manufacturing Empagliflozin contract manufacturing Levofloxacin contract manufacturing Ofloxacin contract manufacturing Olanzapine contract manufacturing Omeprazole contract manufacturing Spironolactone contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
US FDA None 1

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Open risk flags

  • The most recent inspection outcome was VAI, on 30 August 2024.

Sources on this page

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