Guardian Drug Company | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Guardian Drug Company
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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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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Guardian Drug Company

VISIT THE VIRTUAL BOOTH, Contact Details

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 5 News #PharmaBuzz

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FINISHED DOSAGE FORMULATIONS

14 FDF Dossiers, 8 FDA Orange Book, 6 Canada

14 FDF Dossiers
8 FDA Orange Book
6 Canada

INSPECTIONS & REGISTRATIONS

7 FDA, 1 GDUFA

7 FDA
1 GDUFA

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filter Legal Name Reset all filters

10 All

01 10Guardian Drug Co. Inc.

filter District Decision Reset all filters

10 All

01 3No Action Indicated

02 7Voluntary Action Indicated

filter Inspection End Date Reset all filters

10 All

01 12024-11-07

02 12022-02-17

03 12017-11-06

04 22014-08-15

05 22012-06-08

06 12012-03-02

07 12011-02-18

08 12008-10-28

filter City Reset all filters

10 All

01 10Dayton

filter Country/Area Reset all filters

10 All

01 10U.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 : No Action Indicated

Inspection End Date : 2024-11-07

Guardian Drug Company

City : Dayton

State : New Jersey

Country/Area : U.S.A

Zip : 8810

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2024-11-07

Product
Web Link

Stock Recap
#PipelineProspector

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 : Voluntary Action Indicated

Inspection End Date : 2022-02-17

Guardian Drug Company

City : Dayton

State : New Jersey

Country/Area : U.S.A

Zip : 8810

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-02-17

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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 : Voluntary Action Indicated

Inspection End Date : 2017-11-06

Guardian Drug Company

City : Dayton

State : New Jersey

Country/Area : U.S.A

Zip : 8810

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-11-06

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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 : No Action Indicated

Inspection End Date : 2014-08-15

Guardian Drug Company

City : Dayton

State : NJ

Country/Area : U.S.A

Zip : 08810-1508

District : NWJ

Center : CFSAN

Project Area : Food Composition, Standards, Lab...

District Decision : No Action Indicated

Inspection End Date : 2014-08-15

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 : 2014-08-15

Guardian Drug Company

City : Dayton

State : New Jersey

Country/Area : U.S.A

Zip : 8810

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-08-15

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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 : 2012-06-08

Guardian Drug Company

City : Dayton

State : NJ

Country/Area : U.S.A

Zip : 08810-1508

District : NWJ

Center : CFSAN

Project Area : Food Composition, Standards, Lab...

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-06-08

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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 : Voluntary Action Indicated

Inspection End Date : 2012-06-08

Guardian Drug Company

City : Dayton

State : New Jersey

Country/Area : U.S.A

Zip : 8810

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-06-08

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

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 : 2012-03-02

Guardian Drug Company

City : Dayton

State : New Jersey

Country/Area : U.S.A

Zip : 8810

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-03-02

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

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 : 2011-02-18

Guardian Drug Company

City : Dayton

State : New Jersey

Country/Area : U.S.A

Zip : 8810

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-02-18

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

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 : 2008-10-28

Guardian Drug Company

City : Dayton

State : New Jersey

Country/Area : U.S.A

Zip : 8810

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2008-10-28

Product
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#PipelineProspector

Data Compilation
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