Is Aqualex FDA approved?

Aqualex holds 1 FDA-registered establishment in South Korea. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are Aqualex's drugs manufactured?

The FDA register lists Gyeonggi 13219. Registered operations: finished drug manufacture.

Aqualex

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 1
Active NDC listings: 0
Live patents: 0
Countries: 1
Base: South Korea

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Aqualex	Rm 203 27 Dunchon-daero 457beon-gil, Jungwon-gu, Seongnam, Gyeonggi 13219, Korea, South (KOR)	Finished drug manufacture	3010683345687515213

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Common questions

Is Aqualex FDA approved?: Aqualex holds 1 FDA-registered establishment in South Korea. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are Aqualex's drugs manufactured?: The FDA register lists Gyeonggi 13219. Registered operations: finished drug manufacture.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.