Suppliers / Guilin Pharmaceutical

Guilin Pharmaceutical

China 76 employees 2 duplicate records merged Updated 9 July 2026

Guilin Pharmaceutical is an API and finished-dose manufacturer based in China. It holds one active US drug master file. Its filings concentrate with NAFDAC (NG), TMDA (TZ) and NPRA (MY). Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 18 August 2023 as NAI.

1
active US DMFs
0
valid CEPs
1
registered plants 1 with an FDA FEI number
26
filings across 3 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

  • 18 August 2023 NAI US FDA
  • 19 July 2018 VAI US FDA
  • 13 March 2015 VAI US FDA
  • 2 September 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 3002807125

What they file, and where

Molecule Regulators Docs
Bumetanide US FDA 1

Also appears on these molecule pages

Albendazole finished dose Bumetanide API Phloroglucinol finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
NAFDAC (NG) 21 None
TMDA (TZ) 4 None
NPRA (MY) 1 None
US FDA None 1

Questions about Guilin Pharmaceutical

Does Guilin Pharmaceutical hold a US DMF or a CEP?
Guilin Pharmaceutical holds 1 active US drug master file. 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 Guilin Pharmaceutical FDA-registered?
One site operated by Guilin 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 Guilin Pharmaceutical's last inspection go?
The most recent inspection on record closed on 18 August 2023 as NAI (No Action Indicated: nothing objectionable was found). 4 inspections are on file.
Where does Guilin 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 Guilin Pharmaceutical make?
1 molecule is on record against Guilin Pharmaceutical, including Bumetanide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Guilin 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 18 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