Suppliers / Fujian Genohope Biotech

Fujian Genohope Biotech

China Updated 9 July 2026

Fujian Genohope Biotech is an API manufacturer based in China. It holds 7 active US drug master files across a filed portfolio of 4 molecules. Its GMP standing is certified by EMA and US FDA. Its most recent recorded inspection, by US FDA, closed on 16 January 2026 as VAI.

7
active US DMFs
0
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
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

  • 16 January 2026 VAI US FDA

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

Registered plants

Site FDA FEI
Putian, China Not on file
China, China 3025263427

What they file, and where

Molecule Regulators Docs
Semaglutide US FDA 4
Orforglipron US FDA 1
Retatrutide US FDA 1
Tirzepatide US FDA 1

Also appears on these molecule pages

Fulvestrant contract manufacturing Liraglutide contract manufacturing Orforglipron API Retatrutide contract manufacturing Semaglutide contract manufacturing Tirzepatide contract manufacturing

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA None 1
US FDA None 1

Questions about Fujian Genohope Biotech

Does Fujian Genohope Biotech hold a US DMF or a CEP?
Fujian Genohope Biotech holds 7 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 Fujian Genohope Biotech FDA-registered?
One site operated by Fujian Genohope Biotech 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 Fujian Genohope Biotech's last inspection go?
The most recent inspection on record closed on 16 January 2026 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Fujian Genohope Biotech manufacture?
2 registered sites are on record, in China (Putian and China). Every site is listed on this page with the register it came from.
What does Fujian Genohope Biotech make?
4 molecules are on record against Fujian Genohope Biotech, including Semaglutide, Orforglipron, Retatrutide and Tirzepatide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Fujian Genohope Biotech'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 16 January 2026.

Comparable suppliers

Sinopep-Allsino Biopharmaceutical shares 4 molecules Hybio Pharmaceutical shares 3 molecules Zhejiang Peptites Biotech shares 3 molecules El-Peptido (Shanghai) Biopharmaceutical shares 3 molecules Dr Reddy's Laboratories shares 2 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