Sumitomo Pharma America | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Sumitomo Pharma America
FDA

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Cohance Lifesciences, offers full range of CDMO services for small molecule APIs, intermediates, ADCs, Pellets and Formulations.

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pharmacompass-1-m-2026-01-12

LEBSA- Your strategic API source for niche molecules.

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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pharmacompass-2-m-2025-11-03

Sumitomo Pharma America

VIRTUAL BOOTH, Contact Details

VIRTUAL BOOTH
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EVENTS

Webinars & Exhibitions

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DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 7 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
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7 News #PharmaBuzz

DEVELOPMENTS

136 Drugs in Development

136 Drugs in Development

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13 FDF Dossiers, 13 FDA Orange Book

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filter Legal Name Reset all filters

11 All

01 11Sumitomo Pharma America, Inc.

filter District Decision Reset all filters

11 All

01 5No Action Indicated

02 6Voluntary Action Indicated

filter Inspection End Date Reset all filters

11 All

01 12024-08-02

02 12021-11-05

03 12015-01-23

04 12013-05-24

05 12011-12-09

06 22011-04-20

07 12010-06-03

08 12009-10-20

09 22009-09-01

filter City Reset all filters

11 All

01 11Marlborough

filter Country/Area Reset all filters

11 All

01 11U.S.A

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01

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2024-08-02

Sumitomo Pharma America

City : Marlborough

State : Massachusetts

Country/Area : U.S.A

Zip : 1752

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2024-08-02

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2021-11-05

Sumitomo Pharma America

City : Marlborough

State : Massachusetts

Country/Area : U.S.A

Zip : 1752

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2021-11-05

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2015-01-23

Sumitomo Pharma America

City : Marlborough

State : Massachusetts

Country/Area : U.S.A

Zip : 1752

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-01-23

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2013-05-24

Sumitomo Pharma America

City : Marlborough

State : Massachusetts

Country/Area : U.S.A

Zip : 1752

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-05-24

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2011-12-09

Sumitomo Pharma America

City : Marlborough

State : Massachusetts

Country/Area : U.S.A

Zip : 1752

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-12-09

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2011-04-20

Sumitomo Pharma America

City : Marlborough

State : Massachusetts

Country/Area : U.S.A

Zip : 1752

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2011-04-20

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2011-04-20

Sumitomo Pharma America

City : Marlborough

State : Massachusetts

Country/Area : U.S.A

Zip : 1752

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-04-20

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2010-06-03

Sumitomo Pharma America

City : Marlborough

State : Massachusetts

Country/Area : U.S.A

Zip : 1752

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-06-03

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2009-10-20

Sumitomo Pharma America

City : Marlborough

State : Massachusetts

Country/Area : U.S.A

Zip : 1752

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2009-10-20

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

Pharmapack

Not Confirmed

FDA Audited

USA

Pharmapack

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 : 2009-09-01

Sumitomo Pharma America

City : Marlborough

State : Massachusetts

Country/Area : U.S.A

Zip : 1752

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2009-09-01

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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