Suppliers / Zhejiang Guobang

Zhejiang Guobang

China reconciled across 8 public records · 2 entities Updated 9 July 2026

Zhejiang Guobang is an API manufacturer based in China. It holds 16 active US drug master files and 15 valid CEPs across a filed portfolio of 19 molecules. Its GMP standing is certified by EDQM, MFDS (Korea) and EMA, among 4 authorities. Its most recent recorded inspection, by US FDA, closed on 3 March 2025 as VAI.

16
active US DMFs
15
valid CEPs
5
registered plants 2 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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 March 2025 VAI US FDA
  • 10 January 2020 VAI US FDA
  • 24 September 2015 NAI US FDA

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

Registered plants

Site FDA FEI
Weifang, China Not on file
China, China 3002946929
Shangyu, China Not on file
Shaoxing, China Not on file
China, China 3008617115

What they file, and where

Molecule Regulators Docs
Ciprofloxacin EDQM, SFDA (Saudi Arabia), US FDA 6
Clarithromycin EDQM, SFDA (Saudi Arabia), US FDA 4
Doxycycline EDQM, US FDA 3
Azithromycin EDQM, US FDA 2
Moxifloxacin EDQM, US FDA 2
Rivaroxaban EDQM, US FDA 2
Apixaban US FDA 1
Brexpiprazole US FDA 1
Diclazuril For Veterinary Use EDQM 1
Edoxaban US FDA 1
Show all 19 molecules on file
Enrofloxacin For Veterinary Use EDQM 1
Guanfacine US FDA 1
Lanthanum Carbonate US FDA 1
Macitentan US FDA 1
Marbofloxacin For Veterinary Use EDQM 1
Roxithromycin EDQM 1
Solifenacin Succinate EDQM 1
Topiroxostat US FDA 1
Vonoprazan US FDA 1

Also appears on these molecule pages

Azithromycin API Brexpiprazole API Ciprofloxacin API Clarithromycin API Edoxaban API Guanfacine API Lanthanum Carbonate API Macitentan API Marbofloxacin For Veterinary Use API Moxifloxacin API Rivaroxaban API Roxithromycin API
Show 3 more molecule pages
Vonoprazan API Solifenacin API Apixaban API

Filings and GMP by regulator

Regulator Filings GMP certificates
FDA (GH) 1 None
EDQM None 15
MFDS (Korea) None 2
EMA None 2
US FDA None 1

Questions about Zhejiang Guobang

Does Zhejiang Guobang hold a US DMF or a CEP?
Zhejiang Guobang holds 16 active US drug master files and 15 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 Zhejiang Guobang FDA-registered?
2 sites operated by Zhejiang Guobang carry an FDA establishment identifier (FEI), which means they are registered with the FDA as a drug establishment. Registration is not the same as approval or inspection clearance.
How did Zhejiang Guobang's last inspection go?
The most recent inspection on record closed on 3 March 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Zhejiang Guobang manufacture?
5 registered sites are on record, in China (Weifang, China and Shangyu among others). Every site is listed on this page with the register it came from.
What does Zhejiang Guobang make?
19 molecules are on record against Zhejiang Guobang, including Ciprofloxacin, Clarithromycin, Doxycycline and Azithromycin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Guobang's GMP?
Current GMP certificates are on record from EDQM, MFDS (Korea), EMA and 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 3 March 2025.

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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