Suppliers / Jiangsu Lianhuan Pharmaceutical

Jiangsu Lianhuan Pharmaceutical

China 41 employees Updated 9 July 2026

Jiangsu Lianhuan Pharmaceutical is an API manufacturer based in China. It holds 5 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 19 July 2024 as VAI.

5
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
2
filings across 1 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

  • 19 July 2024 VAI US FDA
  • 7 November 2018 NAI US FDA
  • 15 January 2016 NAI US FDA
  • 22 March 2013 VAI US FDA
  • 13 May 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
China, China 3004026935

What they file, and where

Molecule Regulators Docs
Hydrocortisone US FDA 2
Phentolamine US FDA 1
Relugolix US FDA 1
Sacubitril US FDA 1

Also appears on these molecule pages

Hydrocortisone API Phentolamine API Relugolix API Sacubitril API

Filings and GMP by regulator

Regulator Filings GMP certificates
FDA (GH) 2 None
US FDA None 1

Questions about Jiangsu Lianhuan Pharmaceutical

Does Jiangsu Lianhuan Pharmaceutical hold a US DMF or a CEP?
Jiangsu Lianhuan Pharmaceutical holds 5 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 Jiangsu Lianhuan Pharmaceutical FDA-registered?
One site operated by Jiangsu Lianhuan 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 Jiangsu Lianhuan Pharmaceutical's last inspection go?
The most recent inspection on record closed on 19 July 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Jiangsu Lianhuan Pharmaceutical manufacture?
1 registered site is on record, in China (China). Every site is listed on this page with the register it came from.
What does Jiangsu Lianhuan Pharmaceutical make?
4 molecules are on record against Jiangsu Lianhuan Pharmaceutical, including Hydrocortisone, Phentolamine, Relugolix and Sacubitril. Each links through to that molecule's full manufacturer list.
Which regulators recognise Jiangsu Lianhuan 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 VAI, on 19 July 2024.

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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