Suppliers / Korea United Pharmaceuticals

Korea United Pharmaceuticals

South Korea 6 employees Updated 9 July 2026

Korea United Pharmaceuticals is an API manufacturer based in South Korea. It holds one active US drug master file. Its filings concentrate with EMA, EDA (EG) and INFARMED (PT). Its GMP standing is certified by EDA (EG).

1
active US DMFs
0
valid CEPs
0
registered plants
16
filings across 5 regulators

What they file, and where

Molecule Regulators Docs
Azelastine US FDA 1

Also appears on these molecule pages

Azelastine API

Filings and GMP by regulator

Regulator Filings GMP certificates
EMA 10 None
EDA (EG) 3 1
INFARMED (PT) 1 None
SFDA (Saudi Arabia) 1 None
UZPHARM (UZ) 1 None

Questions about Korea United Pharmaceuticals

Does Korea United Pharmaceuticals hold a US DMF or a CEP?
Korea United Pharmaceuticals 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 Korea United Pharmaceuticals make?
1 molecule is on record against Korea United Pharmaceuticals, including Azelastine. Each links through to that molecule's full manufacturer list.
Which regulators recognise Korea United Pharmaceuticals's GMP?
Current GMP certificates are on record from EDA (EG). 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