Suppliers / Lianyungang Runzhong Pharmaceutical

Lianyungang Runzhong Pharmaceutical

China Updated 9 July 2026

Lianyungang Runzhong Pharmaceutical is an API manufacturer based in China. It holds 8 active US drug master files across a filed portfolio of 9 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 26 January 2024 as NAI.

8
active US DMFs
0
valid CEPs
1
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

  • 26 January 2024 NAI US FDA
  • 26 October 2018 NAI US FDA
  • 27 March 2014 NAI US FDA
  • 28 July 2011 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 3003015655

What they file, and where

Molecule Regulators Docs
Fulvestrant SFDA (Saudi Arabia), US FDA 2
Palbociclib SFDA (Saudi Arabia), US FDA 2
Amifostine US FDA 1
Budesonide SFDA (Saudi Arabia) 1
Carfilzomib US FDA 1
Degarelix US FDA 1
Eribulin US FDA 1
Fosaprepitant US FDA 1
Foscarnet US FDA 1

Also appears on these molecule pages

Carfilzomib API Degarelix API Eribulin API Fosaprepitant API Foscarnet API Fulvestrant API Palbociclib API Budesonide API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Lianyungang Runzhong Pharmaceutical

Does Lianyungang Runzhong Pharmaceutical hold a US DMF or a CEP?
Lianyungang Runzhong Pharmaceutical holds 8 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 Lianyungang Runzhong Pharmaceutical FDA-registered?
One site operated by Lianyungang Runzhong 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 Lianyungang Runzhong Pharmaceutical's last inspection go?
The most recent inspection on record closed on 26 January 2024 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Lianyungang Runzhong 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 Lianyungang Runzhong Pharmaceutical make?
9 molecules are on record against Lianyungang Runzhong Pharmaceutical, including Fulvestrant, Palbociclib, Amifostine and Budesonide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Lianyungang Runzhong 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 NAI, on 26 January 2024.

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Ranked by shared active ingredients where we have them, otherwise by country and comparable credentials.

Sources on this page

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