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

Please Wait

Applying Filters...

Grow Your Pharma Business Digitally

Find Suppliers : API/FDF
- Search Our Integrated Database
Services
Excipients
CDMO Prospector
- Demo Dashboard
Drugs in Dev.
News
Blog
Market Place
Login

Unither Pharmaceuticals
FDA

LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

Contact Supplier

Munit offers scalable GMP micronization and particle size engineering to enhance drug solubility, bioavailability, and performance.

Contact Supplier

pharmacompass-1-m-2025-11-03

Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

Contact Supplier

Jai Radhe Sales is your partner for all your sourcing needs.

Contact Supplier

pharmacompass-2-m-2025-11-03

Unither Pharmaceuticals

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 28 News #PharmaBuzz

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

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

52 FDF Dossiers, 27 Europe, 25 Listed Dossiers

52 FDF Dossiers
27 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

Xls

Filters

Reset all filters

Filters

FILTER :

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 4France

02 6U.S.A

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

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 : U.S.A

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

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

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 : France

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

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

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 : U.S.A

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

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

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 : France

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

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

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 : U.S.A

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

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

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 : France

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

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

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 : U.S.A

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

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

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 : France

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

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

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 : U.S.A

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

AIChE Annual Meeting

Not Confirmed

FDA Audited

USA

AIChE Annual Meeting

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 : U.S.A

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

Contact us
to update this info

Privacy policy
Terms and conditions
Disclaimers
Ask Us!