Suppliers / Zhuhai United Laboratories

Zhuhai United Laboratories

China Updated 9 July 2026

Zhuhai United Laboratories is an API manufacturer based in China. It holds one active US drug master file and 11 valid CEPs across a filed portfolio of 12 molecules. Its filings concentrate with ARCSA (EC), TMDA (TZ) and MINSA (CR). Its GMP standing is certified by EMA, MFDS (Korea) and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 3 August 2023 as OAI.

1
active US DMFs
11
valid CEPs
4
registered plants 1 with an FDA FEI number
3
filings across 3 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
6 of 6 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

  • 3 August 2023 OAI US FDA
  • 16 July 2019 OAI US FDA
  • 15 September 2017 OAI US FDA
  • 31 March 2015 OAI US FDA
  • 23 October 2012 NAI US FDA
  • 3 September 2009 NAI US FDA

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

Registered plants

Site FDA FEI
Sanzao Town, China Not on file
ZHUHAI - TAIWAN, China Not on file
Zhuhai, China Not on file
China, China 3006531950

What they file, and where

Molecule Regulators Docs
Potassium Clavulanate EDQM 4
Amoxicillin SFDA (Saudi Arabia) 2
Amoxicillin Sodium EDQM 2
Amoxicillin Trihydrate EDQM 2
Ampicillin SFDA (Saudi Arabia), US FDA 2
Sulbactam EDQM, SFDA (Saudi Arabia) 2
Ampicillin Sodium EDQM 1
Ampicillin Trihydrate Compacted EDQM 1
Cefoperazone SFDA (Saudi Arabia) 1
Cefotaxime SFDA (Saudi Arabia) 1
Show all 12 molecules on file
Ceftriaxone SFDA (Saudi Arabia) 1
Meropenem SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Amoxicillin API Ampicillin API Cefoperazone API Cefotaxime API Ceftriaxone API Meropenem API Potassium Clavulanate API Sulbactam API

Filings and GMP by regulator

Regulator Filings GMP certificates
ARCSA (EC) 1 None
TMDA (TZ) 1 None
MINSA (CR) 1 None
EMA None 3
MFDS (Korea) None 2
ANVISA (Brazil) None 1

Questions about Zhuhai United Laboratories

Does Zhuhai United Laboratories hold a US DMF or a CEP?
Zhuhai United Laboratories holds 1 active US drug master file and 11 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 United Laboratories FDA-registered?
One site operated by Zhuhai United Laboratories 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 United Laboratories's last inspection go?
The most recent inspection on record closed on 3 August 2023 as OAI (Official Action Indicated, the worst classification: objectionable conditions were found and regulatory action was warranted). 6 inspections are on file, of which 4 closed as OAI.
Where does Zhuhai United Laboratories manufacture?
4 registered sites are on record, in China (Sanzao Town, Zhuhai - Taiwan and Zhuhai among others). Every site is listed on this page with the register it came from.
What does Zhuhai United Laboratories make?
12 molecules are on record against Zhuhai United Laboratories, including Potassium Clavulanate, Amoxicillin, Amoxicillin Sodium and Amoxicillin Trihydrate. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhuhai United Laboratories's GMP?
Current GMP certificates are on record from EMA, MFDS (Korea) and ANVISA (Brazil). 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 OAI, on 3 August 2023.

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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