Suppliers / Henan Topfond Sci-Tech

Henan Topfond Sci-Tech

China Updated 9 July 2026

Henan Topfond Sci-Tech is an API manufacturer based in China. It holds 2 active US drug master files and 2 valid CEPs. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 22 November 2024 as VAI.

2
active US DMFs
2
valid CEPs
2
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 November 2024 VAI US FDA

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

Registered plants

Site FDA FEI
Zhumadian, China Not on file
China, China 3011865872

What they file, and where

Molecule Regulators Docs
Simvastatin EDQM, US FDA 4

Also appears on these molecule pages

Simvastatin API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Henan Topfond Sci-Tech

Does Henan Topfond Sci-Tech hold a US DMF or a CEP?
Henan Topfond Sci-Tech holds 2 active US drug master files and 2 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 Henan Topfond Sci-Tech FDA-registered?
One site operated by Henan Topfond Sci-Tech 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 Henan Topfond Sci-Tech's last inspection go?
The most recent inspection on record closed on 22 November 2024 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Henan Topfond Sci-Tech manufacture?
2 registered sites are on record, in China (Zhumadian and China). Every site is listed on this page with the register it came from.
What does Henan Topfond Sci-Tech make?
1 molecule is on record against Henan Topfond Sci-Tech, including Simvastatin. Each links through to that molecule's full manufacturer list.
Which regulators recognise Henan Topfond Sci-Tech's GMP?
Current GMP certificates are on record from 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. Henan Topfond Sci-Tech 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 22 November 2024.

Comparable suppliers

Hetero shares 1 molecule Jubilant Biosys shares 1 molecule Lupin shares 1 molecule Biocon shares 1 molecule Teva 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