Suppliers / Henan Lihua Pharmaceutical

Henan Lihua Pharmaceutical

China Updated 9 July 2026

Henan Lihua Pharmaceutical is an API manufacturer based in China. It holds 28 active US drug master files across a filed portfolio of 14 molecules. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 13 July 2021 as NAI.

28
active US DMFs
0
valid CEPs
2
registered plants 1 with an FDA FEI number
7
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
4 of 4 confirmed
EU GMP
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026. EudraGMDP (MIA + third-country GMP certs), read 4 May 2026.

Inspection history

  • 13 July 2021 NAI US FDA
  • 14 December 2017 OAI US FDA
  • 22 January 2016 VAI US FDA
  • 10 September 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
Anyang, Henan, China Not on file
China, China 3001164052

What they file, and where

Molecule Regulators Docs
Hydrocortisone US FDA 6
Betamethasone US FDA 4
Prednisolone SFDA (Saudi Arabia), US FDA 4
Methylprednisolone US FDA 3
Mometasone Furoate US FDA 2
Prednisone US FDA 2
Beclomethasone Dipropionate US FDA 1
Budesonide US FDA 1
Cortisone Acetate US FDA 1
Dexamethasone US FDA 1
Show all 14 molecules on file
Fludrocortisone US FDA 1
Fluocinolone Acetonide US FDA 1
Fluorometholone US FDA 1
Triamcinolone US FDA 1

Also appears on these molecule pages

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 7 None
EMA None 1

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Open risk flags

  • The most recent inspection outcome was NAI, on 13 July 2021.

Sources on this page

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