Suppliers / Hangzhou Apextide Biomedical Technology

Hangzhou Apextide Biomedical Technology

China Updated 9 July 2026

Hangzhou Apextide Biomedical Technology is an API manufacturer based in China. It holds 2 active US drug master files across a filed portfolio of 2 molecules. Its GMP standing is certified by US FDA. Its most recent recorded inspection, by US FDA, closed on 1 November 2024 as VAI.

2
active US DMFs
0
valid CEPs
1
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

  • 1 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
China, China 3027905876

What they file, and where

Molecule Regulators Docs
Inclisiran US FDA 1
Tirzepatide US FDA 1

Also appears on these molecule pages

Tirzepatide API

Filings and GMP by regulator

Regulator Filings GMP certificates
US FDA None 1

Questions about Hangzhou Apextide Biomedical Technology

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

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Open risk flags

  • The most recent inspection outcome was VAI, on 1 November 2024.

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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability
EudraGMDP and national regulators
GMP certificates