Suppliers / Anqiu Lu'an Pharmaceutical

Anqiu Lu'an Pharmaceutical

China 2 duplicate records merged Updated 9 July 2026

Anqiu Lu'an Pharmaceutical is a contract manufacturer based in China. It holds 5 active US drug master files and one valid CEP. Its filings concentrate with MINSA (CR), ARCSA (EC) and NMPA (CN). Its GMP standing is certified by MFDS (Korea), EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 26 September 2025 as VAI.

5
active US DMFs
1
valid CEPs
2
registered plants 1 with an FDA FEI number
16
filings across 4 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

  • 26 September 2025 VAI US FDA
  • 18 May 2018 VAI US FDA
  • 1 April 2016 VAI US FDA
  • 20 September 2013 VAI US FDA
  • 1 July 2011 NAI US FDA
  • 1 October 2009 VAI 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 3004261627

What they file, and where

Molecule Regulators Docs
Acetaminophen EDQM, SFDA (Saudi Arabia), US FDA 8

Also appears on these molecule pages

Acetaminophen contract manufacturing Paracetamol contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 8 None
ARCSA (EC) 3 None
NMPA (CN) 3 None
INVIMA (CO) 2 None
MFDS (Korea) None 2
EMA None 2
US FDA None 1

Questions about Anqiu Lu'an Pharmaceutical

Does Anqiu Lu'an Pharmaceutical hold a US DMF or a CEP?
Anqiu Lu'an Pharmaceutical holds 5 active US drug master files and 1 valid CEP. 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 Anqiu Lu'an Pharmaceutical FDA-registered?
One site operated by Anqiu Lu'an 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 Anqiu Lu'an Pharmaceutical's last inspection go?
The most recent inspection on record closed on 26 September 2025 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 6 inspections are on file.
Where does Anqiu Lu'an Pharmaceutical manufacture?
2 registered sites are on record, in China (Weifang and China). Every site is listed on this page with the register it came from.
What does Anqiu Lu'an Pharmaceutical make?
1 molecule is on record against Anqiu Lu'an Pharmaceutical, including Acetaminophen. Each links through to that molecule's full manufacturer list.
Which regulators recognise Anqiu Lu'an Pharmaceutical's GMP?
Current GMP certificates are on record from 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 26 September 2025.

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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