Suppliers / Shandong Anshun Pharmaceutical

Shandong Anshun Pharmaceutical

China Updated 9 July 2026

Shandong Anshun Pharmaceutical is an API manufacturer based in China. It holds 3 active US drug master files and 3 valid CEPs across a filed portfolio of 3 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 22 September 2023 as NAI.

3
active US DMFs
3
valid CEPs
3
registered plants 1 with an FDA FEI number
0
filings across 0 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
1 of 1 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.

Inspection history

  • 22 September 2023 NAI US FDA

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

Registered plants

Site FDA FEI
Dezhou City, China Not on file
Dezhou, China Not on file
China, China 3015326904

What they file, and where

Molecule Regulators Docs
Piperacillin EDQM, SFDA (Saudi Arabia), US FDA 7
Tazobactam SFDA (Saudi Arabia), US FDA 4
Nusinersen US FDA 1

Also appears on these molecule pages

Nusinersen API Piperacillin API Tazobactam API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
US FDA None 1

Questions about Shandong Anshun Pharmaceutical

Does Shandong Anshun Pharmaceutical hold a US DMF or a CEP?
Shandong Anshun Pharmaceutical holds 3 active US drug master files and 3 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 Anshun Pharmaceutical FDA-registered?
One site operated by Shandong Anshun 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 Anshun Pharmaceutical's last inspection go?
The most recent inspection on record closed on 22 September 2023 as NAI (No Action Indicated: nothing objectionable was found). 1 inspection is on file.
Where does Shandong Anshun Pharmaceutical manufacture?
3 registered sites are on record, in China (Dezhou City, Dezhou and China). Every site is listed on this page with the register it came from.
What does Shandong Anshun Pharmaceutical make?
3 molecules are on record against Shandong Anshun Pharmaceutical, including Piperacillin, Tazobactam and Nusinersen. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shandong Anshun Pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea) 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.

Comparing suppliers?

Choose your molecules and target markets. Shandong Anshun 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 NAI, on 22 September 2023.

Comparable suppliers

Apitoria Pharma shares 2 molecules Acs Dobfar shares 2 molecules Shandong Anxin Pharmaceutical shares 2 molecules Natco Pharma shares 1 molecule Fresenius Kabi shares 1 molecule

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