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

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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Guardian Drug Company

VISIT THE VIRTUAL BOOTH, Contact Details

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INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 4 NEWS #PharmaBuzz

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FINISHED DOSAGE FORMULATIONS

12 FDF Dossiers, 6 FDA Orange Book, 6 Canada

12 FDF Dossiers
6 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

7 All

01 7Guardian Drug Co. Inc.

filter District Decision Reset all filters

7 All

01 2No Action Indicated

02 5Voluntary Action Indicated

filter Inspection End Date Reset all filters

7 All

01 22014-08-15

02 22012-06-08

03 12012-03-02

04 12011-02-18

05 12008-10-28

filter City Reset all filters

7 All

01 7Dayton

filter Country/Area Reset all filters

7 All

01 7US

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01

FDA Audited

USA

Pharma, Lab & Chemical Expo

Not Confirmed

FDA Audited

USA

Pharma, Lab & Chemical Expo

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 : US

Zip : 08810-1508

District : NWJ

Center : CDER

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

02

FDA Audited

USA

Pharma, Lab & Chemical Expo

Not Confirmed

FDA Audited

USA

Pharma, Lab & Chemical Expo

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 : US

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

03

FDA Audited

USA

Pharma, Lab & Chemical Expo

Not Confirmed

FDA Audited

USA

Pharma, Lab & Chemical Expo

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 : US

Zip : 08810-1508

District : NWJ

Center : CDER

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

04

FDA Audited

USA

Pharma, Lab & Chemical Expo

Not Confirmed

FDA Audited

USA

Pharma, Lab & Chemical Expo

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 : US

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

Pharma, Lab & Chemical Expo

Not Confirmed

FDA Audited

USA

Pharma, Lab & Chemical Expo

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 : NJ

Country/Area : US

Zip : 08810-1508

District : NWJ

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2008-10-28

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

Pharma, Lab & Chemical Expo

Not Confirmed

FDA Audited

USA

Pharma, Lab & Chemical Expo

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 : NJ

Country/Area : US

Zip : 08810-1508

District : NWJ

Center : CDER

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

07

FDA Audited

USA

Pharma, Lab & Chemical Expo

Not Confirmed

FDA Audited

USA

Pharma, Lab & Chemical Expo

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 : NJ

Country/Area : US

Zip : 08810-1508

District : NWJ

Center : CDER

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

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