Is Sucampo Pharma Americas, LLC FDA approved?

Sucampo Pharma Americas, LLC 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 Sucampo Pharma Americas, LLC's drugs manufactured?

The FDA register lists KOBE; SANDA. Registered operations: analytical testing, active ingredient (API) manufacture, finished drug manufacture.

Sucampo Pharma Americas, LLC

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

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Registered sites: 2
Active NDC listings: 0
Live patents: 6
Countries: 1
Base: Japan

Authorisation

Registered operations

Analytical testing2Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
SUCAMPO PHARMA LIMITED LIABILITY COMPANYRegistrant: Sucampo Pharma Americas, LLC	6-7-6, MINATOJIMAMINAMIMACHI, CHUO-KU KOBEHAIBURIDDOBIJINESUSENTA, KOBE, Hyogo 650-0047, Japan (JPN)	Analytical testing	3009036781691314841
SUCAMPO PHARMA LIMITED LIABILITY COMPANYRegistrant: Sucampo Pharma Americas, LLC	4-1, TECHNOPARK, SANDA, Hyogo 669-1339, Japan (JPN)	Analytical testing, Active ingredient (API) manufacture, Finished drug manufacture	3004520523718192151

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
8338639	AMITIZAlubiprostone	product	Jan 2027
8779187	AMITIZAlubiprostone	product	Jan 2027
8026393	AMITIZAlubiprostone	product	Oct 2027

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Enquiry

Common questions

Is Sucampo Pharma Americas, LLC FDA approved?: Sucampo Pharma Americas, LLC 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 Sucampo Pharma Americas, LLC's drugs manufactured?: The FDA register lists KOBE; SANDA. Registered operations: analytical testing, active ingredient (API) manufacture, 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.