Unither Pharmaceuticals | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Unither Pharmaceuticals
FDA

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

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Kikkoman Biochemifa Company advances global health and safety through precision-driven innovation in biotech and food testing.

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dmfs-not-supported-m-2025-06-30

granules-india-limited-m-2025-07-07

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Allsino Pharma excels in R&D & manufacturing of RSMs, GMP intermediates, & APIs; ISO-certified, GMP-compliant, accredited by NMPA.

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jdmfs-not-supported-m-2025-06-30

Unither Pharmaceuticals

VISIT THE VIRTUAL BOOTH, Contact Details

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EVENTS

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Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 27 News #PharmaBuzz

Interview #SpeakPharma
Vlog #PharmaReel
Data Compilation #PharmaFlow
27 News #PharmaBuzz

FINISHED DOSAGE FORMULATIONS

50 FDF Dossiers, 25 Europe, 25 Listed Dossiers

50 FDF Dossiers
25 Europe
25 Listed Dossiers

SERVICES

Analytical, Drug Product Manufacturing, Sales, Marketing, Registration, Packaging, API & Drug Product Development

Analytical
- 1 Extractables and Leachables
- 1 Analytical Method Development
Drug Product Manufacturing
Sales, Marketing, Registration
- 1 Regulatory Affairs / Pharmacovigilance
Packaging
- 7 Contract Services
API & Drug Product Development
- 9 Formulation Development

INSPECTIONS & REGISTRATIONS

10 FDA, 12 EDQM, 2 GDUFA, 3 Others

10 FDA
12 EDQM
2 GDUFA
3 Others

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filter Legal Name Reset all filters

10 All

01 4Laboratoire Unither

02 6Unither Manufacturing LLC.

filter District Decision Reset all filters

10 All

01 2No Action Indicated

02 8Voluntary Action Indicated

filter Inspection End Date Reset all filters

10 All

01 12019-05-22

02 12018-06-21

03 12017-03-01

04 12015-09-15

05 12015-06-01

06 12013-09-19

07 12012-06-15

08 12011-05-16

09 12010-11-23

10 12010-01-19

filter City Reset all filters

10 All

01 4Coutances

02 6Rochester

filter Country/Area Reset all filters

10 All

01 4FR

02 6US

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

EPS

Not Confirmed

FDA Audited

USA

EPS

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 : 2019-05-22

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2019-05-22

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

EPS

Not Confirmed

FDA Audited

USA

EPS

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 : 2018-06-21

Unither Pharmaceuticals

City : Coutances

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2018-06-21

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

EPS

Not Confirmed

FDA Audited

USA

EPS

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 : 2017-03-01

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-03-01

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

EPS

Not Confirmed

FDA Audited

USA

EPS

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 : 2015-09-15

Unither Pharmaceuticals

City : Coutances

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-09-15

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

EPS

Not Confirmed

FDA Audited

USA

EPS

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 : 2015-06-01

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-06-01

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

EPS

Not Confirmed

FDA Audited

USA

EPS

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 : 2013-09-19

Unither Pharmaceuticals

City : Coutances

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-09-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

EPS

Not Confirmed

FDA Audited

USA

EPS

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 : 2012-06-15

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2012-06-15

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

08

FDA Audited

USA

EPS

Not Confirmed

FDA Audited

USA

EPS

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 : 2011-05-16

Unither Pharmaceuticals

City : Coutances

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2011-05-16

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

09

FDA Audited

USA

EPS

Not Confirmed

FDA Audited

USA

EPS

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 : 2010-11-23

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2010-11-23

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

10

FDA Audited

USA

EPS

Not Confirmed

FDA Audited

USA

EPS

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 : 2010-01-19

Unither Pharmaceuticals

City : Rochester

State : NY

Country/Area : US

Zip : 14623-3233

District : NYK

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2010-01-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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