Suppliers / Zhuhai Rundu Pharmaceutical

Zhuhai Rundu Pharmaceutical

China 15 employees Updated 9 July 2026

Zhuhai Rundu Pharmaceutical is an API manufacturer based in China. It holds 10 active US drug master files and 10 valid CEPs across a filed portfolio of 12 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 17 February 2025 as VAI.

10
active US DMFs
10
valid CEPs
4
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
2 of 2 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 17 February 2025 VAI US FDA
  • 20 September 2019 VAI US FDA

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

Registered plants

Site FDA FEI
Zhuhai, China Not on file
Sanzao Town, China Not on file
Zhuhai City, China Not on file
China, China 3009954717

What they file, and where

Molecule Regulators Docs
Irbesartan EDQM, SFDA (Saudi Arabia), US FDA 4
Valsartan EDQM, SFDA (Saudi Arabia), US FDA 4
Candesartan Cilexetil EDQM, SFDA (Saudi Arabia) 3
Olmesartan Medoxomil EDQM, SFDA (Saudi Arabia) 3
Hydroxychloroquine EDQM, US FDA 2
Sacubitril US FDA 2
Voriconazole EDQM, US FDA 2
Candesartan US FDA 1
Losartan EDQM 1
Olmesartan US FDA 1
Show all 12 molecules on file
Sacubitril/Valsartan US FDA 1
Telmisartan EDQM 1

Also appears on these molecule pages

Candesartan API Candesartan Cilexetil API Hydroxychloroquine API Irbesartan API Olmesartan Medoxomil API Sacubitril/Valsartan API Valsartan API Voriconazole API Losartan API Telmisartan API Sacubitril API Olmesartan API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Zhuhai Rundu Pharmaceutical

Does Zhuhai Rundu Pharmaceutical hold a US DMF or a CEP?
Zhuhai Rundu Pharmaceutical holds 10 active US drug master files and 10 valid CEPs. 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 Zhuhai Rundu Pharmaceutical FDA-registered?
One site operated by Zhuhai Rundu 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 Zhuhai Rundu Pharmaceutical's last inspection go?
The most recent inspection on record closed on 17 February 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Zhuhai Rundu Pharmaceutical manufacture?
4 registered sites are on record, in China (Zhuhai, Sanzao Town and Zhuhai City among others). Every site is listed on this page with the register it came from.
What does Zhuhai Rundu Pharmaceutical make?
12 molecules are on record against Zhuhai Rundu Pharmaceutical, including Irbesartan, Valsartan, Candesartan Cilexetil and Olmesartan Medoxomil. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhuhai Rundu 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.

Comparing suppliers?

Choose your molecules and target markets. Zhuhai Rundu Pharmaceutical comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 17 February 2025.

Comparable suppliers

Dr Reddy's Laboratories shares 5 molecules Alembic Pharmaceuticals shares 5 molecules Zydus Lifesciences shares 5 molecules Macleods Pharmaceuticals shares 5 molecules Hetero shares 4 molecules

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