Suppliers / Shandong Anhong Pharmaceutical

Shandong Anhong Pharmaceutical

China Updated 9 July 2026

Shandong Anhong Pharmaceutical is an API manufacturer based in China. It holds 26 active US drug master files and 14 valid CEPs. Its GMP standing is certified by EMA. Its most recent recorded inspection, by US FDA, closed on 22 February 2019 as VAI.

26
active US DMFs
14
valid CEPs
3
registered plants 1 with an FDA FEI number
1
filings across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Plants
1 of 1 confirmed
Inspections
3 of 3 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

  • 22 February 2019 VAI US FDA
  • 2 September 2016 VAI US FDA
  • 13 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
Dezhou, China Not on file
Dezhou City, China Not on file
China, China 3003877289

What they file, and where

Molecule Regulators Docs
Gefitinib EDQM, SFDA (Saudi Arabia), US FDA 3
Sorafenib EDQM, SFDA (Saudi Arabia) 3
Cefotaxime EDQM, US FDA 2
Ertapenem US FDA 2
Etoposide EDQM, US FDA 2
Exemestane EDQM, US FDA 2
Meropenem Trihydrate EDQM 2
Palbociclib SFDA (Saudi Arabia), US FDA 2
Pemetrexed SFDA (Saudi Arabia), US FDA 2
Ropivacaine EDQM, US FDA 2
Show all 30 molecules on file
Terbinafine EDQM, US FDA 2
Abemaciclib US FDA 1
Abiraterone US FDA 1
Afatinib US FDA 1
Azacitidine US FDA 1
Bexarotene US FDA 1
Cabazitaxel US FDA 1
Cilastatin US FDA 1
Cilastatin Sodium EDQM 1
Enzalutamide US FDA 1
Imipenem US FDA 1
Imipenem Monohydrate EDQM 1
Lasmiditan US FDA 1
Lenalidomide US FDA 1
Meropenem US FDA 1
Nintedanib US FDA 1
Nintedanib Esylate SFDA (Saudi Arabia) 1
Olaparib US FDA 1
Pemetrexed Disodium SFDA (Saudi Arabia) 1
Pemetrexed Disodium 2.5-Hydrate EDQM 1

Also appears on these molecule pages

Abemaciclib API Abiraterone API Afatinib API Azacitidine API Bexarotene API Cabazitaxel API Cefotaxime API Cilastatin API Enzalutamide API Ertapenem API Etoposide API Exemestane API
Show 16 more molecule pages
Gefitinib API Imipenem API Lasmiditan API Lenalidomide API Meropenem API Nintedanib API Olaparib API Palbociclib API Pemetrexed API Pemetrexed Disodium API Pemetrexed Disodium 2.5-Hydrate API Regorafenib API Ropivacaine API Sorafenib API Tenofovir Disoproxil API Terbinafine API

Filings and GMP by regulator

Regulator Filings GMP certificates
MINSA (CR) 1 None
EMA None 4

Questions about Shandong Anhong Pharmaceutical

Does Shandong Anhong Pharmaceutical hold a US DMF or a CEP?
Shandong Anhong Pharmaceutical holds 26 active US drug master files and 14 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 Anhong Pharmaceutical FDA-registered?
One site operated by Shandong Anhong 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 Anhong Pharmaceutical's last inspection go?
The most recent inspection on record closed on 22 February 2019 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 3 inspections are on file.
Where does Shandong Anhong Pharmaceutical manufacture?
3 registered sites are on record, in China (Dezhou, Dezhou City and China). Every site is listed on this page with the register it came from.
What does Shandong Anhong Pharmaceutical make?
30 molecules are on record against Shandong Anhong Pharmaceutical, including Gefitinib, Sorafenib, Cefotaxime and Ertapenem. Each links through to that molecule's full manufacturer list.
Which regulators recognise Shandong Anhong Pharmaceutical's GMP?
Current GMP certificates are on record from EMA. 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 22 February 2019.

Comparable suppliers

Hetero shares 19 molecules MSN Laboratories shares 17 molecules Cipla shares 12 molecules Dr Reddy's Laboratories shares 11 molecules Shilpa Pharma Lifesciences shares 9 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