Septodont Inc | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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SEPTODONT INC
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DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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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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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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SEPTODONT INC

VISIT THE VIRTUAL BOOTH, Contact Details

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EVENTS

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DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 3 NEWS #PharmaBuzz

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VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
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FINISHED DOSAGE FORMULATIONS

42 FDF Dossiers, 18 FDA Orange Book, 3 Europe, 21 Canada

42 FDF Dossiers
18 FDA Orange Book
3 Europe
21 Canada

INSPECTIONS & REGISTRATIONS

9 FDA, 1 GDUFA

9 FDA
1 GDUFA

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FILTER :

filter Legal Name Reset all filters

9 All

01 2Septodont

02 7Septodont Inc.

filter District Decision Reset all filters

9 All

01 3No Action Indicated

02 6Voluntary Action Indicated

filter Inspection End Date Reset all filters

9 All

01 12017-07-26

02 12014-07-04

03 22014-05-19

04 12013-06-12

05 12011-08-25

06 32010-04-14

filter City Reset all filters

9 All

01 1Cambridge

02 7Louisville

03 1St Maur Des Fosses Cedex

filter Country/Area Reset all filters

9 All

01 1CA

02 1FR

03 7US

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01

FDA Audited

USA

Antibody Engineering

Not Confirmed

FDA Audited

USA

Antibody Engineering

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 : 2010-04-14

SEPTODONT INC

City : Louisville

State : CO

Country/Area : US

Zip : 80027-3028

District : DEN

Center : CDRH

Project Area : Compliance: Devices

District Decision : No Action Indicated

Inspection End Date : 2010-04-14

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

Antibody Engineering

Not Confirmed

FDA Audited

USA

Antibody Engineering

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 : 2010-04-14

SEPTODONT INC

City : Louisville

State : CO

Country/Area : US

Zip : 80027-3028

District : DEN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2010-04-14

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

Antibody Engineering

Not Confirmed

FDA Audited

USA

Antibody Engineering

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 : 2010-04-14

SEPTODONT INC

City : Louisville

State : CO

Country/Area : US

Zip : 80027-3028

District : DEN

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : No Action Indicated

Inspection End Date : 2010-04-14

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

Antibody Engineering

Not Confirmed

FDA Audited

USA

Antibody Engineering

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 : 2017-07-26

SEPTODONT INC

City : Cambridge

State :

Country/Area : CA

Zip :

District : ORA

Center : CDER

Project Area : Postmarket Surv. and Epidemiolog...

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-07-26

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

Antibody Engineering

Not Confirmed

FDA Audited

USA

Antibody Engineering

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 : 2011-08-25

SEPTODONT INC

City : Louisville

State : CO

Country/Area : US

Zip : 80027-3028

District : DEN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-08-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

Antibody Engineering

Not Confirmed

FDA Audited

USA

Antibody Engineering

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 : 2013-06-12

SEPTODONT INC

City : Louisville

State : CO

Country/Area : US

Zip : 80027-3028

District : DEN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-06-12

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

Antibody Engineering

Not Confirmed

FDA Audited

USA

Antibody Engineering

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 : 2014-05-19

SEPTODONT INC

City : Louisville

State : CO

Country/Area : US

Zip : 80027-3028

District : DEN

Center : CDRH

Project Area : Compliance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-05-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

Antibody Engineering

Not Confirmed

FDA Audited

USA

Antibody Engineering

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 : 2014-05-19

SEPTODONT INC

City : Louisville

State : CO

Country/Area : US

Zip : 80027-3028

District : DEN

Center : CDRH

Project Area : Postmarket Assurance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-05-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

Antibody Engineering

Not Confirmed

FDA Audited

USA

Antibody Engineering

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 : 2014-07-04

SEPTODONT INC

City : St Maur Des Fosses Cedex

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2014-07-04

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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