Suppliers / Topharman Shandong

Topharman Shandong

China Updated 9 July 2026

Topharman Shandong is an API manufacturer based in China. It holds 9 active US drug master files and one valid CEP across a filed portfolio of 9 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 17 May 2024 as VAI.

9
active US DMFs
1
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
2 of 2 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

  • 17 May 2024 VAI US FDA
  • 28 September 2016 NAI 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
Anqiu City, China Not on file
China, China 3010708767

What they file, and where

Molecule Regulators Docs
Tadalafil EDQM, US FDA 2
Aripiprazole US FDA 1
Brexpiprazole US FDA 1
Dapoxetine US FDA 1
Efinaconazole US FDA 1
Neratinib US FDA 1
Rivaroxaban US FDA 1
Tecovirimat US FDA 1
Telmisartan US FDA 1

Also appears on these molecule pages

Brexpiprazole API Dapoxetine API Efinaconazole API Tadalafil API Telmisartan API Rivaroxaban API Aripiprazole API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1
US FDA None 1

Questions about Topharman Shandong

Does Topharman Shandong hold a US DMF or a CEP?
Topharman Shandong holds 9 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 Topharman Shandong FDA-registered?
One site operated by Topharman Shandong 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 Topharman Shandong's last inspection go?
The most recent inspection on record closed on 17 May 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 2 inspections are on file.
Where does Topharman Shandong manufacture?
3 registered sites are on record, in China (Weifang, Anqiu City and China). Every site is listed on this page with the register it came from.
What does Topharman Shandong make?
9 molecules are on record against Topharman Shandong, including Tadalafil, Aripiprazole, Brexpiprazole and Dapoxetine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Topharman Shandong's GMP?
Current GMP certificates are on record from 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 17 May 2024.

Comparable suppliers

Macleods Pharmaceuticals shares 4 molecules Apitoria Pharma shares 3 molecules Cipla shares 3 molecules Alivus Life Sciences shares 3 molecules Alembic Pharmaceuticals shares 3 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