Collegium Pharmaceutical | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Collegium Pharmaceutical
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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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Collegium Pharmaceutical

VISIT THE VIRTUAL BOOTH, Contact Details

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 88 News #PharmaBuzz

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DEVELOPMENTS

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FINISHED DOSAGE FORMULATIONS

25 FDF Dossiers, 25 FDA Orange Book

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25 FDA Orange Book

INSPECTIONS & REGISTRATIONS

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7 FDA

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filter Legal Name Reset all filters

7 All

01 2BioDelivery Sciences International, Inc.

02 5Collegium Pharmaceutical, Inc

filter District Decision Reset all filters

7 All

01 4No Action Indicated

02 3Voluntary Action Indicated

filter Inspection End Date Reset all filters

7 All

01 12021-05-21

02 12019-04-24

03 12019-03-15

04 32010-08-31

05 12008-10-23

filter City Reset all filters

7 All

01 2Raleigh

02 5Stoughton

filter Country/Area Reset all filters

7 All

01 7U.S.A

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01

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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 : 2021-05-21

BioDelivery Sciences

City : Raleigh

State : North Carolina

Country/Area : U.S.A

Zip : 27612

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2021-05-21

Product
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Data Compilation
#PharmaFlow

02

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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 : 2019-04-24

BioDelivery Sciences

City : Raleigh

State : North Carolina

Country/Area : U.S.A

Zip : 27612

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2019-04-24

Product
Web Link

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Data Compilation
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03

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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 : 2019-03-15

Collegium Pharmaceutical

City : Stoughton

State : Massachusetts

Country/Area : U.S.A

Zip : 2072

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2019-03-15

Product
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04

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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 : 2010-08-31

Collegium Pharmaceutical

City : Stoughton

State : Massachusetts

Country/Area : U.S.A

Zip : 2072

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-08-31

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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 : 2010-08-31

Collegium Pharmaceutical

City : Stoughton

State : Massachusetts

Country/Area : U.S.A

Zip : 2072

District :

Center :

Project Area : Postmarket Surv. and Epidemiolog...

District Decision : No Action Indicated

Inspection End Date : 2010-08-31

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06

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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 : 2010-08-31

Collegium Pharmaceutical

City : Stoughton

State : Massachusetts

Country/Area : U.S.A

Zip : 2072

District :

Center :

Project Area : Unapproved and Misbranded Drugs

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-08-31

Product
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07

FDA Audited

USA

VMX

Not Confirmed

FDA Audited

USA

VMX

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 : 2008-10-23

Collegium Pharmaceutical

City : Stoughton

State : Massachusetts

Country/Area : U.S.A

Zip : 2072

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2008-10-23

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