Is Chugai Pharmaceutical Co., Ltd. FDA approved?

Chugai Pharmaceutical Co., Ltd. holds 3 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 Chugai Pharmaceutical Co., Ltd.'s drugs manufactured?

The FDA register lists Fujieda; Kita-ku; Utsunomiya. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

What drugs does Chugai Pharmaceutical Co., Ltd. make?

13 products are listed under Chugai Pharmaceutical Co., Ltd. in the openFDA NDC Directory, most often as injection, solution; injection, solution, concentrate; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Chugai Pharmaceutical Co., Ltd.

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

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Registered sites: 3
Active NDC listings: 13
Live patents: 0
Countries: 1
Base: Japan

Authorisation

Registered operations

Analytical testing3Active ingredient (API) manufacture2Finished drug manufacture3

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Chugai Pharma Manufacturing Co., LtdRegistrant: Chugai Pharmaceutical Co., Ltd.	2500 Takayanagi, Fujieda, SZO 426-0041, Japan (JPN)	Analytical testing, Finished drug manufacture	3002806758716464883
Chugai Pharma Manufacturing Co., LtdRegistrant: Chugai Pharmaceutical Co., Ltd.	5-5-1, UKIMA, Kita-ku, TKY 115-0051, Japan (JPN)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3004109596691033815
Chugai Pharma Manufacturing Co., LtdRegistrant: Chugai Pharmaceutical Co., Ltd.	16-3 Kiyohara Kogyodanchi, Utsunomiya, TCG 321-3231, Japan (JPN)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3006942691716464891

Catalogue

Drug listings by form and route

13 active NDC listings: 13 drug for further processing. By marketing category: DRUG FOR FURTHER PROCESSING 13.

Dosage form	NDCs
injection, solution	6
injection, solution, concentrate	3
liquid	3
capsule	1

Route	NDCs

Labeller name on the listing	NDCs
chugai pharmaceutical co., ltd.	13

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	Alectinib Hydrochloride	capsule	60422-211DRUG FOR FURTHER PROCESSING
-	Emicizumab	injection, solution	60422-260DRUG FOR FURTHER PROCESSING
-	Emicizumab	injection, solution	60422-270DRUG FOR FURTHER PROCESSING
-	Emicizumab	injection, solution	60422-280DRUG FOR FURTHER PROCESSING
-	Emicizumab	injection, solution	60422-290DRUG FOR FURTHER PROCESSING
-	Emicizumab	liquid	60422-302DRUG FOR FURTHER PROCESSING
-	Nemolizumab	liquid	60422-402DRUG FOR FURTHER PROCESSING
-	Satralizumab	injection, solution	60422-367DRUG FOR FURTHER PROCESSING
-	Tocilizumab	liquid	60422-202DRUG FOR FURTHER PROCESSING
-	Tocilizumab	injection, solution	60422-220DRUG FOR FURTHER PROCESSING
-	Tocilizumab	injection, solution, concentrate	60422-230DRUG FOR FURTHER PROCESSING
-	Tocilizumab	injection, solution, concentrate	60422-240DRUG FOR FURTHER PROCESSING
-	Tocilizumab	injection, solution, concentrate	60422-250DRUG FOR FURTHER PROCESSING

Neighbours

Registered in the same town

Hisamitsu Pharmaceutical Co., Inc.Utsunomiya, JPN

Compare

Comparable companies in Japan

Daiichi Sankyo Europe GmbH3 sites · 11 NDC
Sumitomo Chemical Company, Limited3 sites · 8 NDC
Meiji Seika Pharma Co., Ltd.3 sites · 1 NDC
Sumitomo Pharma Co., Ltd.2 sites · 24 NDC
TAYCA CORPORATION2 sites · 22 NDC
Shionogi Pharma Co., Ltd.4 sites · 17 NDC
Hisamitsu Pharmaceutical Co., Inc.2 sites · 16 NDC
Terumo Pharmaceutical Services GmbH4 sites · 12 NDC
Bushu Pharmaceuticals, Ltd.2 sites · 11 NDC
ASO Pharmaceutical Co. Ltd.2 sites · 10 NDC

Enquiry

Common questions

Is Chugai Pharmaceutical Co., Ltd. FDA approved?: Chugai Pharmaceutical Co., Ltd. holds 3 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 Chugai Pharmaceutical Co., Ltd.'s drugs manufactured?: The FDA register lists Fujieda; Kita-ku; Utsunomiya. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.
What drugs does Chugai Pharmaceutical Co., Ltd. make?: 13 products are listed under Chugai Pharmaceutical Co., Ltd. in the openFDA NDC Directory, most often as injection, solution; injection, solution, concentrate; 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.