Suppliers / Hefei Xinzhu Biological Technology

Hefei Xinzhu Biological Technology

China Updated 9 July 2026

Hefei Xinzhu Biological Technology is an API manufacturer based in China. It holds one active US drug master file.

1
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
Sources: FDA Establishment Registration, read 4 May 2026.

Registered plants

Site FDA FEI
China, China 3037651207

What they file, and where

Molecule Regulators Docs
Teriparatide US FDA 1

Also appears on these molecule pages

Teriparatide API

Questions about Hefei Xinzhu Biological Technology

Does Hefei Xinzhu Biological Technology hold a US DMF or a CEP?
Hefei Xinzhu Biological Technology holds 1 active US drug master file. 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 Hefei Xinzhu Biological Technology FDA-registered?
One site operated by Hefei Xinzhu Biological 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.
Where does Hefei Xinzhu Biological 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 Hefei Xinzhu Biological Technology make?
1 molecule is on record against Hefei Xinzhu Biological Technology, including Teriparatide. Each links through to that molecule's full manufacturer list.

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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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