Suppliers / Kunshan Oriental Pharmaceutical

Kunshan Oriental Pharmaceutical

China Updated 9 July 2026

Kunshan Oriental Pharmaceutical is an API manufacturer based in China. It holds 2 active US drug master files.

2
active US DMFs
0
valid CEPs
0
registered plants
0
filings across 0 regulators

What they file, and where

Molecule Regulators Docs
Phenytoin US FDA 2

Also appears on these molecule pages

Phenytoin API

Questions about Kunshan Oriental Pharmaceutical

Does Kunshan Oriental Pharmaceutical hold a US DMF or a CEP?
Kunshan Oriental Pharmaceutical 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.
What does Kunshan Oriental Pharmaceutical make?
1 molecule is on record against Kunshan Oriental Pharmaceutical, including Phenytoin. 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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Sources on this page

FDA
Drug master files, establishment registration, inspection classifications
EDQM
Certificates of suitability