Otsuka America Pharmaceutical, Inc. | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Otsuka America Pharmaceutical, Inc.
FDA

Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.

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Otsuka America Pharmaceutical, Inc.

VIRTUAL BOOTH, Contact Details

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EVENTS

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Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 33 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
33 News #PharmaBuzz

DEVELOPMENTS

6 Drugs in Development

6 Drugs in Development

FINISHED DOSAGE FORMULATIONS

2 FDF Dossiers, 2 FDA Orange Book

2 FDF Dossiers
2 FDA Orange Book

INSPECTIONS & REGISTRATIONS

10 FDA

10 FDA

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filter Legal Name Reset all filters

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01 10Otsuka America Pharmaceutical, Inc.

filter District Decision Reset all filters

10 All

01 4No Action Indicated

02 6Voluntary Action Indicated

filter Inspection End Date Reset all filters

10 All

01 22017-05-19

02 22015-05-06

03 22014-09-26

04 22013-02-25

05 12010-10-27

06 12009-04-14

filter City Reset all filters

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01 10Rockville

filter Country/Area Reset all filters

10 All

01 10U.S.A

Supplier Virtual Booth

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01

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-19

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Compliance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-19

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2015-05-06

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Compliance: Devices

District Decision : No Action Indicated

Inspection End Date : 2015-05-06

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2015-05-06

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : No Action Indicated

Inspection End Date : 2015-05-06

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-09-26

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Compliance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-09-26

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-09-26

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-09-26

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2013-02-25

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Project Evaluation: Devices

District Decision : No Action Indicated

Inspection End Date : 2013-02-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : No Action Indicated

Inspection End Date : 2013-02-25

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : No Action Indicated

Inspection End Date : 2013-02-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-10-27

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Project Evaluation: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-10-27

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-04-14

Otsuka America Pharmaceutical, Inc.

City : Rockville

State : MD

Country/Area : U.S.A

Zip : 20850-3238

District : BLT

Center : CDRH

Project Area : Compliance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-04-14

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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