Is Nipro Pharma Corporation FDA approved?

Nipro Pharma 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 Nipro Pharma Corporation's drugs manufactured?

The FDA register lists Iwasegun; ODATE. Registered operations: analytical testing, finished drug manufacture.

What drugs does Nipro Pharma Corporation make?

2 products are listed under Nipro Pharma Corporation in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; tablet. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Nipro Pharma 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

Analytical testing2Finished drug manufacture2

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Nipro Pharma Corporation	428, Okanouchi, Kagamiishi-machi, Iwasegun, Fukushima 969-0401, Japan (JPN)	Analytical testing, Finished drug manufacture	3010317053693428221
NIPRO PHARMA CORPORATION	AZAMAEDANO5-7, NIIDA, ODATE, 018-5751, Japan (JPN)	Analytical testing, Finished drug manufacture	3017952330717831064

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
injection, powder, lyophilized, for solution	1
tablet	1

Route	NDCs

Labeller name on the listing	NDCs
nipro pharma corporation	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Ceftobiprole Medocaril Sodium for Injection	injection, powder, lyophilized, for solution	72122-004DRUG FOR FURTHER PROCESSING
-	gefitinib tablets	tablet	72122-001DRUG FOR FURTHER PROCESSING

Compare

Comparable companies in Japan

Sumitomo Pharma Co., Ltd.2 sites · 24 NDC
Hisamitsu Pharmaceutical Co., Inc.2 sites · 16 NDC
Bushu Pharmaceuticals, Ltd.2 sites · 11 NDC
ASO Pharmaceutical Co. Ltd.2 sites · 10 NDC
Lead Chemical Co., Ltd.2 sites · 7 NDC
SUMITOMO OSAKA CEMENT CO., LTD.2 sites · 6 NDC
UBE Corporation2 sites · 1 NDC
CMIC Pharma Science Co., Ltd.2 sites · 0 NDC
Japan Food Research Laboratories2 sites · 0 NDC
KATAYAMA SEIYAKUSYO CO., LTD.2 sites · 0 NDC

Enquiry

Common questions

Is Nipro Pharma Corporation FDA approved?: Nipro Pharma 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 Nipro Pharma Corporation's drugs manufactured?: The FDA register lists Iwasegun; ODATE. Registered operations: analytical testing, finished drug manufacture.
What drugs does Nipro Pharma Corporation make?: 2 products are listed under Nipro Pharma Corporation in the openFDA NDC Directory, most often as injection, powder, lyophilized, for solution; tablet. 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.