Is KYOWA HAKKO BIO CO., LTD. FDA approved?

KYOWA HAKKO BIO CO., LTD. holds 1 FDA-registered establishment 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 KYOWA HAKKO BIO CO., LTD.'s drugs manufactured?

The FDA register lists Hofu. Registered operations: active ingredient (API) manufacture.

What drugs does KYOWA HAKKO BIO CO., LTD. make?

14 products are listed under KYOWA HAKKO BIO CO., LTD. in the openFDA NDC Directory, most often as powder. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

KYOWA HAKKO BIO CO., LTD.

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

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Registered sites: 1
Active NDC listings: 14
Live patents: 0
Countries: 1
Base: Japan

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Kyowa Hakko Bio Co., Ltd.Registrant: KYOWA HAKKO BIO CO., LTD.	1-1 Kyowa-cho, Hofu, Yamaguchi 747-8522, Japan (JPN)	Active ingredient (API) manufacture	3002807424690598749

Catalogue

Drug listings by form and route

14 active NDC listings: 14 bulk ingredient. By marketing category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING 14.

Dosage form	NDCs
powder	14

Route	NDCs

Labeller name on the listing	NDCs
kyowa hakko bio co., ltd.	14

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	L-Arginine	powder	12497-1004BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Cysteine Monohydrochloride Monohydrate	powder	12497-1013BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Glutamic acid	powder	12497-1012BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Glutathione oxidized	powder	12497-1054BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Histidine	powder	12497-1032BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Isoleucine	powder	12497-1008BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Lysine Acetate	powder	12497-1033BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Lysine Monohydrochloride	powder	12497-1028BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Methionine	powder	12497-1027BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Phenylalanine	powder	12497-1024BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Threonine	powder	12497-1016BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Tryptophan	powder	12497-1019BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	L-Valine	powder	12497-1022BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
-	TAURINE	powder	12497-1047BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

Compare

Comparable companies in Japan

Sakai Chemical Industry Co., Ltd.1 site · 20 NDC
Kyowa Kirin Co., Ltd.1 site · 11 NDC
Titan Kogyo , Ltd.1 site · 8 NDC
Kyowa Pharma Chemical Co., Ltd.1 site · 6 NDC
Alps Pharmaceutical Ind. Co., Ltd.1 site · 5 NDC
Kongo Chemical Co., Ltd.1 site · 5 NDC
Yuki Gosei Kogyo Co., Ltd.1 site · 5 NDC
Juzen Chemical Corporation1 site · 4 NDC
Asahi Kasei Finechem Co., Ltd.1 site · 3 NDC
NISSAN CHEMICAL CORPORATION1 site · 3 NDC

Enquiry

Common questions

Is KYOWA HAKKO BIO CO., LTD. FDA approved?: KYOWA HAKKO BIO CO., LTD. holds 1 FDA-registered establishment 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 KYOWA HAKKO BIO CO., LTD.'s drugs manufactured?: The FDA register lists Hofu. Registered operations: active ingredient (API) manufacture.
What drugs does KYOWA HAKKO BIO CO., LTD. make?: 14 products are listed under KYOWA HAKKO BIO CO., LTD. in the openFDA NDC Directory, most often as powder. 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.