Monosol Rx | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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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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MonoSol Rx

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INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 6 NEWS #PharmaBuzz

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INSPECTIONS & REGISTRATIONS

6 FDA, 1 EDQM

6 FDA
1 EDQM

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02 5Voluntary Action Indicated

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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 : Voluntary Action Indicated

Inspection End Date : 2008-10-23

City : Portage

State : IN

Country/Area : US

Zip : 46368-1234

District : DET

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2008-10-23

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 : 2009-06-09

City : Portage

State : IN

Country/Area : US

Zip : 46368-1595

District : DET

Center : CFSAN

Project Area : Foodborne Biological Hazards

District Decision : No Action Indicated

Inspection End Date : 2009-06-09

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
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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 : Voluntary Action Indicated

Inspection End Date : 2010-03-23

City : Portage

State : IN

Country/Area : US

Zip : 46368-1234

District : DET

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-03-23

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 : 2011-06-28

City : Portage

State : IN

Country/Area : US

Zip : 46368-1234

District : DET

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-06-28

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 : 2012-09-13

City : Portage

State : IN

Country/Area : US

Zip : 46368-1234

District : DET

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-09-13

Product
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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 : 2015-04-03

City : Portage

State : IN

Country/Area : US

Zip : 46368-1234

District : DET

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-04-03

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