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Details of Summit Biosciences's U.S. FDA Inspections. Original Data: FDA Inspection Database

Summit Biosciences
FDA

EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Bora Pharmaceuticals- Making success more certain.

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Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Summit Biosciences

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
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EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 4 NEWS #PharmaBuzz

INTERVIEW #SpeakPharma
VLOG #PharmaReel
DATA COMPILATION #PharmaFlow
4 NEWS #PharmaBuzz

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

1 FDF Dossiers, 1 FDA Orange Book

1 FDF Dossiers
1 FDA Orange Book

SERVICES

Drug Product Manufacturing, API & Drug Product Development

Drug Product Manufacturing
- 1 Nasal
- 1 Spray
API & Drug Product Development
- 2 Formulation Development

INSPECTIONS & REGISTRATIONS

4 FDA, 2 EDQM, 1 GDUFA

4 FDA
2 EDQM
1 GDUFA

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FILTER :

filter Legal Name Reset all filters

4 All

01 4Summit Biosciences LLC

filter District Decision Reset all filters

4 All

01 4No Action Indicated

filter Inspection End Date Reset all filters

4 All

01 12020-02-04

02 12017-06-23

03 12015-06-18

04 12014-02-28

filter City Reset all filters

4 All

01 4Lexington

filter Country/Area Reset all filters

4 All

01 4US

FDA
EDQM
GDUFA

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01

FDA Audited

USA

Luxepack

Not Confirmed

FDA Audited

USA

Luxepack

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 : 2014-02-28

Summit Biosciences

City : Lexington

State : KY

Country/Area : US

Zip : 40511-1200

District : CIN

Center : CDRH

Project Area : Compliance: Devices

District Decision : No Action Indicated

Inspection End Date : 2014-02-28

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

Luxepack

Not Confirmed

FDA Audited

USA

Luxepack

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 : 2015-06-18

Summit Biosciences

City : Lexington

State : KY

Country/Area : US

Zip : 40511-1200

District : CIN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2015-06-18

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

Luxepack

Not Confirmed

FDA Audited

USA

Luxepack

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 : 2017-06-23

Summit Biosciences

City : Lexington

State : KY

Country/Area : US

Zip : 40511-1200

District : CIN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2017-06-23

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

Luxepack

Not Confirmed

FDA Audited

USA

Luxepack

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 : 2020-02-04

Summit Biosciences

City : Lexington

State : KY

Country/Area : US

Zip : 40511-1200

District : CIN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2020-02-04

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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