Is Nissui Corporation FDA approved?

Nissui Corporation holds 2 FDA-registered establishments in Japan. 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 Nissui Corporation's drugs manufactured?

The FDA register lists KAMISU; TSUKUBA. Registered operations: active ingredient (API) manufacture.

What drugs does Nissui Corporation make?

2 products are listed under Nissui Corporation in the openFDA NDC Directory, most often as liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Nissui Corporation

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

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Registered sites: 2
Active NDC listings: 2
Live patents: 0
Countries: 1
Base: Japan

Authorisation

Registered operations

Active ingredient (API) manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Nissui Corporation	18-2, HIGASHIFUKASHIBA, KAMISU, IBARAKI 314-0103, Japan (JPN)	Active ingredient (API) manufacture	3009589537715315693
Nissui Corporation	7, OKUBO, TSUKUBA, IBARAKI 300-2611, Japan (JPN)	Active ingredient (API) manufacture	3004317885706198215

Catalogue

Drug listings by form and route

2 active NDC listings: 2 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 2.

Dosage form	NDCs
liquid	2

Route	NDCs

Labeller name on the listing	NDCs
nissui corporation	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Icosapent Ethyl	liquid	71215-101DRUG FOR FURTHER PROCESSING
-	Icosapent Ethyl	liquid	71215-102DRUG FOR FURTHER PROCESSING

Neighbours

Registered in the same town

Nippon Shikizai,inc.Tsukuba, JPN

Compare

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UBE Corporation2 sites · 1 NDC
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Sucampo Pharma Americas, LLC2 sites · 0 NDC
Taiho Oncology, Inc.2 sites · 0 NDC

Enquiry

Common questions

Is Nissui Corporation FDA approved?: Nissui Corporation holds 2 FDA-registered establishments in Japan. 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 Nissui Corporation's drugs manufactured?: The FDA register lists KAMISU; TSUKUBA. Registered operations: active ingredient (API) manufacture.
What drugs does Nissui Corporation make?: 2 products are listed under Nissui Corporation in the openFDA NDC Directory, most often as liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

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.