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

Filings and GMP by regulator

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

Questions about Henan Lihua Pharmaceutical

Does Henan Lihua Pharmaceutical hold a US DMF or a CEP?
Henan Lihua Pharmaceutical holds 28 active US drug master files. 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 Henan Lihua Pharmaceutical FDA-registered?
One site operated by Henan Lihua 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 Henan Lihua Pharmaceutical's last inspection go?
The most recent inspection on record closed on 13 July 2021 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file, of which 1 closed as OAI.
Where does Henan Lihua Pharmaceutical manufacture?
2 registered sites are on record, in China (Anyang, Henan and China). Every site is listed on this page with the register it came from.
What does Henan Lihua Pharmaceutical make?
14 molecules are on record against Henan Lihua Pharmaceutical, including Hydrocortisone, Betamethasone, Prednisolone and Methylprednisolone. Each links through to that molecule's full manufacturer list.
Which regulators recognise Henan Lihua Pharmaceutical's GMP?
Current GMP certificates are on record from EMA. 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 13 July 2021.

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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