Suppliers / China Gateway Pharmaceutical Development

China Gateway Pharmaceutical Development

China Updated 9 July 2026

China Gateway Pharmaceutical Development is an API manufacturer based in China. It holds one active US drug master file.

1
active US DMFs
0
valid CEPs
0
registered plants
0
filings across 0 regulators

What they file, and where

Molecule Regulators Docs
Montelukast US FDA 1

Also appears on these molecule pages

Montelukast API

Questions about China Gateway Pharmaceutical Development

Does China Gateway Pharmaceutical Development hold a US DMF or a CEP?
China Gateway Pharmaceutical Development 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.
What does China Gateway Pharmaceutical Development make?
1 molecule is on record against China Gateway Pharmaceutical Development, including Montelukast. 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