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01 2Astex Pharmaceuticals, Inc

02 2Interpharma Praha A.S.

03 10Otsuka America Pharmaceutical, Inc.

04 3Otsuka Chemical Co., Ltd.

05 23Otsuka Pharmaceutical Co., Ltd.

06 6Otsuka Pharmaceutical Development & Commercialization, Inc

07 2Otsuka Pharmaceutical Development & Commercialization, Inc.

08 7Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.

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PharmaCompass

01

FDA Audited

USA
PharmaSynergy
Not Confirmed
arrow

FDA Audited

USA
arrow
PharmaSynergy
Not Confirmed

Otsuka Holdings

City : Kanzaki-Gun

State :

Country/Area : Japan

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2025-07-11

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02

FDA Audited

USA
PharmaSynergy
Not Confirmed
arrow

FDA Audited

USA
arrow
PharmaSynergy
Not Confirmed

Otsuka Holdings

City : Naka-Gun

State :

Country/Area : Japan

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2025-06-17

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03

FDA Audited

USA
PharmaSynergy
Not Confirmed
arrow

FDA Audited

USA
arrow
PharmaSynergy
Not Confirmed

Otsuka Holdings

City : Tokushima

State :

Country/Area : Japan

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2025-05-16

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04

FDA Audited

USA
PharmaSynergy
Not Confirmed
arrow

FDA Audited

USA
arrow
PharmaSynergy
Not Confirmed

Otsuka Pharmaceutical

City : Tokushima

State :

Country/Area : Japan

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2024-03-22

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05

FDA Audited

USA
PharmaSynergy
Not Confirmed
arrow

FDA Audited

USA
arrow
PharmaSynergy
Not Confirmed

Otsuka Chemical Co Ltd

City : Tokushima

State :

Country/Area : Japan

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2023-09-15

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06

FDA Audited

USA
PharmaSynergy
Not Confirmed
arrow

FDA Audited

USA
arrow
PharmaSynergy
Not Confirmed

Otsuka Pharmaceutical

City : Rockville

State : Maryland

Country/Area : U.S.A

Zip : 20850

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2023-09-07

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07

FDA Audited

USA
PharmaSynergy
Not Confirmed
arrow

FDA Audited

USA
arrow
PharmaSynergy
Not Confirmed

Otsuka Pharmaceutical

City : Rockville

State : Maryland

Country/Area : U.S.A

Zip : 20850

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2023-02-27

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08

FDA Audited

USA
PharmaSynergy
Not Confirmed
arrow

FDA Audited

USA
arrow
PharmaSynergy
Not Confirmed

Otsuka Holdings

City : Mima

State :

Country/Area : Japan

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2022-12-06

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09

FDA Audited

USA
PharmaSynergy
Not Confirmed
arrow

FDA Audited

USA
arrow
PharmaSynergy
Not Confirmed

Astex Pharmaceuticals

City : Pleasanton

State : California

Country/Area : U.S.A

Zip : 94588

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2020-02-24

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10

FDA Audited

USA
PharmaSynergy
Not Confirmed
arrow

FDA Audited

USA
arrow
PharmaSynergy
Not Confirmed

Otsuka Holdings

City : Naka-Gun

State :

Country/Area : Japan

Zip :

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-10-22

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