Suppliers / Zhejiang Peptites Biotech

Zhejiang Peptites Biotech

China 7 employees Updated 9 July 2026

Zhejiang Peptites Biotech is an API manufacturer based in China. It holds 11 active US drug master files across a filed portfolio of 7 molecules. Its GMP standing is certified by MFDS (Korea) and US FDA. Its most recent recorded inspection, by US FDA, closed on 8 September 2023 as VAI.

11
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

  • 8 September 2023 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 3015685285

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2
US FDA None 1

Questions about Zhejiang Peptites Biotech

Does Zhejiang Peptites Biotech hold a US DMF or a CEP?
Zhejiang Peptites Biotech holds 11 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 Zhejiang Peptites Biotech FDA-registered?
One site operated by Zhejiang Peptites 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 Zhejiang Peptites Biotech's last inspection go?
The most recent inspection on record closed on 8 September 2023 as VAI (Voluntary Action Indicated: issues were found but did not warrant regulatory action). 1 inspection is on file.
Where does Zhejiang Peptites Biotech 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 Zhejiang Peptites Biotech make?
7 molecules are on record against Zhejiang Peptites Biotech, including Semaglutide, Tirzepatide, Etelcalcetide and Leuprolide. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Peptites Biotech's GMP?
Current GMP certificates are on record from MFDS (Korea) 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 8 September 2023.

Sources on this page

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