Suppliers / Zhejiang Syncozymes Bio-pharmaceutical

Zhejiang Syncozymes Bio-pharmaceutical

China Updated 9 July 2026

Zhejiang Syncozymes Bio-pharmaceutical is an API manufacturer based in China. It holds 2 active US drug master files and one valid CEP across a filed portfolio of 2 molecules. Its GMP standing is certified by MFDS (Korea).

2
active US DMFs
1
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
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
Shaoxing, China Not on file
China, China 3028704559

What they file, and where

Molecule Regulators Docs
Quetiapine EDQM, US FDA 2
Bupropion US FDA 1

Also appears on these molecule pages

Quetiapine API Bupropion API

Filings and GMP by regulator

Regulator Filings GMP certificates
MFDS (Korea) None 2

Questions about Zhejiang Syncozymes Bio-pharmaceutical

Does Zhejiang Syncozymes Bio-pharmaceutical hold a US DMF or a CEP?
Zhejiang Syncozymes Bio-pharmaceutical holds 2 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 Zhejiang Syncozymes Bio-pharmaceutical FDA-registered?
One site operated by Zhejiang Syncozymes Bio-pharmaceutical 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.
Where does Zhejiang Syncozymes Bio-pharmaceutical manufacture?
2 registered sites are on record, in China (Shaoxing and China). Every site is listed on this page with the register it came from.
What does Zhejiang Syncozymes Bio-pharmaceutical make?
2 molecules are on record against Zhejiang Syncozymes Bio-pharmaceutical, including Quetiapine and Bupropion. Each links through to that molecule's full manufacturer list.
Which regulators recognise Zhejiang Syncozymes Bio-pharmaceutical's GMP?
Current GMP certificates are on record from MFDS (Korea). 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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Sources on this page

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