Suppliers / Shandong Anxin Pharmaceutical

Shandong Anxin Pharmaceutical

China Updated 9 July 2026

Shandong Anxin Pharmaceutical is an API manufacturer based in China. It holds 19 active US drug master files and 12 valid CEPs across a filed portfolio of 18 molecules. Its filings concentrate with MINSA (CR) and EDE (AE). Its GMP standing is certified by EMA, ANVISA (Brazil) and MFDS (Korea). Its most recent recorded inspection, by US FDA, closed on 18 September 2019 as VAI.

19
active US DMFs
12
valid CEPs
6
registered plants 1 with an FDA FEI number
5
filings across 2 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
5 of 5 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

  • 18 September 2019 VAI US FDA
  • 1 September 2017 VAI US FDA
  • 2 June 2015 VAI US FDA
  • 27 September 2013 NAI US FDA
  • 25 June 2010 VAI 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
Dongjia Town, China Not on file
Jinan, China Not on file
Dongjia Town, China Not on file
China, China 3004229375

What they file, and where

Molecule Regulators Docs
Piperacillin EDQM, SFDA (Saudi Arabia), US FDA 7
Amikacin EDQM, SFDA (Saudi Arabia), US FDA 4
Tazobactam US FDA 4
Aprepitant SFDA (Saudi Arabia), US FDA 2
Capecitabine EDQM, US FDA 2
Hydroxyurea EDQM, US FDA 2
Imatinib SFDA (Saudi Arabia), US FDA 2
Imatinib Mesilate EDQM 2
Tadalafil EDQM, US FDA 2
Azithromycin EDQM 1
Show all 18 molecules on file
Celecoxib EDQM 1
Docetaxel Trihydrate EDQM 1
Fosaprepitant US FDA 1
Olmesartan US FDA 1
Olmesartan Medoxomil EDQM 1
Piperacillin Sodium EDQM 1
Sulbactam US FDA 1
Tofacitinib US FDA 1

Also appears on these molecule pages

Amikacin API Aprepitant API Azithromycin API Capecitabine API Celecoxib API Docetaxel API Fosaprepitant API Hydroxyurea API Imatinib API Imatinib Mesilate API Olmesartan API Olmesartan Medoxomil API
Show 5 more molecule pages
Piperacillin API Sulbactam API Tadalafil API Tazobactam API Tofacitinib API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 3 None
EDE (AE) 2 None
EMA None 8
ANVISA (Brazil) None 7
MFDS (Korea) None 2

Questions about Shandong Anxin Pharmaceutical

Does Shandong Anxin Pharmaceutical hold a US DMF or a CEP?
Shandong Anxin Pharmaceutical holds 19 active US drug master files and 12 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 Shandong Anxin Pharmaceutical FDA-registered?
One site operated by Shandong Anxin 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 Shandong Anxin Pharmaceutical's last inspection go?
The most recent inspection on record closed on 18 September 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 5 inspections are on file.
Where does Shandong Anxin Pharmaceutical manufacture?
6 registered sites are on record, in United Arab Emirates and China (Jinan, Jinan and Dongjia Town among others). Every site is listed on this page with the register it came from.
What does Shandong Anxin Pharmaceutical make?
18 molecules are on record against Shandong Anxin Pharmaceutical, including Piperacillin, Amikacin, Tazobactam and Aprepitant. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shandong Anxin Pharmaceutical's GMP?
Current GMP certificates are on record from EMA, ANVISA (Brazil) and MFDS (Korea). 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.

Comparing suppliers?

Choose your molecules and target markets. Shandong Anxin Pharmaceutical comes back tiered against every other supplier able to file there.

Start for free
No sales call.

Open risk flags

  • The most recent inspection outcome was VAI, on 18 September 2019.

Comparable suppliers

Apitoria Pharma shares 10 molecules Hetero shares 9 molecules MSN Laboratories shares 8 molecules Dr Reddy's Laboratories shares 8 molecules Alivus Life Sciences shares 6 molecules

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