Suppliers / Qilu Antibiotics Pharmaceutical

Qilu Antibiotics Pharmaceutical

China Updated 9 July 2026

The public registers hold a second record for Qilu Antibiotics Pharmaceutical. The fuller profile, with 31 active US DMFs and 12 valid CEPs, is at Qilu Pharmaceutical. Figures on this page cover only this record.

Qilu Antibiotics Pharmaceutical is an API and finished-dose manufacturer based in China. It holds 5 active US drug master files across a filed portfolio of 10 molecules. Its filings concentrate with JFDA (JO), EDE (AE) and MINSA (CR). Its GMP standing is certified by US FDA and ANVISA (Brazil). Its most recent recorded inspection, by US FDA, closed on 30 May 2023 as VAI.

5
active US DMFs
0
valid CEPs
3
registered plants 1 with an FDA FEI number
12
filings across 5 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

  • 30 May 2023 VAI US FDA
  • 16 August 2018 NAI US FDA
  • 22 September 2015 VAI US FDA
  • 20 September 2013 NAI US FDA

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

Registered plants

Site FDA FEI
Jinan, United Arab Emirates Not on file
JINAN, China Not on file
China, China 3009831352

What they file, and where

Molecule Regulators Docs
Cefixime SFDA (Saudi Arabia), US FDA 3
Ceftazidime SFDA (Saudi Arabia), US FDA 3
Cefepime Dihydrochloride SFDA (Saudi Arabia) 2
Avibactam SFDA (Saudi Arabia) 1
Cefazolin SFDA (Saudi Arabia) 1
Cefepime US FDA 1
Cefpodoxime US FDA 1
Cefprozil US FDA 1
Ceftriaxone SFDA (Saudi Arabia) 1
Cefuroxime SFDA (Saudi Arabia) 1

Also appears on these molecule pages

Avibactam API Cefazolin API Cefepime API Cefixime API Cefpodoxime API Cefprozil API Ceftazidime API Ceftriaxone API Cefuroxime API Ertapenem finished dose

Filings and GMP by regulator

Regulator Filings GMP certificates
JFDA (JO) 4 None
EDE (AE) 3 None
MINSA (CR) 3 None
ARCSA (EC) 1 None
DIGEMAPS (DO) 1 None
US FDA None 1
ANVISA (Brazil) None 1

Questions about Qilu Antibiotics Pharmaceutical

Does Qilu Antibiotics Pharmaceutical hold a US DMF or a CEP?
Qilu Antibiotics Pharmaceutical holds 5 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 Qilu Antibiotics Pharmaceutical FDA-registered?
One site operated by Qilu Antibiotics 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 Qilu Antibiotics Pharmaceutical's last inspection go?
The most recent inspection on record closed on 30 May 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 4 inspections are on file.
Where does Qilu Antibiotics Pharmaceutical manufacture?
3 registered sites are on record, in United Arab Emirates and China (Jinan, Jinan and China). Every site is listed on this page with the register it came from.
What does Qilu Antibiotics Pharmaceutical make?
10 molecules are on record against Qilu Antibiotics Pharmaceutical, including Cefixime, Ceftazidime, Cefepime Dihydrochloride and Avibactam. Each links through to that molecule's full manufacturer list.
Which regulators recognise Qilu Antibiotics Pharmaceutical's GMP?
Current GMP certificates are on record from US FDA 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

  • 5 active litigation matters are on record.
  • The most recent inspection outcome was VAI, on 30 May 2023.

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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