Novel Laboratories, Inc. | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Novel Laboratories, Inc.
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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Novel Laboratories, Inc.

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Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 38 News #PharmaBuzz

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FINISHED DOSAGE FORMULATIONS

100 FDF Dossiers, 100 FDA Orange Book

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14 FDA, 1 GDUFA

14 FDA
1 GDUFA

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filter Legal Name Reset all filters

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01 14Novel Laboratories, Inc. d.b.a Lupin Somerset

filter District Decision Reset all filters

14 All

01 4No Action Indicated

02 1Official Action Indicated

03 9Voluntary Action Indicated

filter Inspection End Date Reset all filters

14 All

01 12024-05-17

02 12023-01-13

03 12022-03-30

04 12020-11-05

05 12018-11-08

06 12018-02-23

07 12017-08-08

08 12017-02-14

09 12015-11-17

10 12015-01-22

11 12014-06-24

12 12013-08-26

13 12011-06-29

14 12010-03-05

filter City Reset all filters

14 All

01 14Somerset

filter Country/Area Reset all filters

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01 14U.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 : 2024-05-17

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2024-05-17

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 : Voluntary Action Indicated

Inspection End Date : 2023-01-13

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2023-01-13

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 : 2022-03-30

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2022-03-30

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 : Official Action Indicated

Inspection End Date : 2020-11-05

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Official Action Indicated

Inspection End Date : 2020-11-05

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 : 2018-11-08

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-11-08

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 : Voluntary Action Indicated

Inspection End Date : 2018-02-23

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-02-23

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 : 2017-08-08

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-08-08

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 : No Action Indicated

Inspection End Date : 2017-02-14

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-02-14

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 : 2015-11-17

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-11-17

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 : No Action Indicated

Inspection End Date : 2015-01-22

Novel Laboratories, Inc.

City : Somerset

State : New Jersey

Country/Area : U.S.A

Zip : 8873

District :

Center :

Project Area : Bioresearch Monitoring

District Decision : No Action Indicated

Inspection End Date : 2015-01-22

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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