Summit Biosciences | FDA | Inspections | Form 483 | Warning Letters | PharmaCompass.com

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Summit Biosciences
FDA

Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.

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Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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pharmacompass-1-m-2026-01-12

IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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Cosma S.p.A., part of CFM Group with AMSA & Clarochem, provides global pharma & veterinary health with 300+ tons of FDA-approved APIs.

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pharmacompass-2-m-2025-11-03

Summit Biosciences

VIRTUAL BOOTH, Contact Details

VIRTUAL BOOTH
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

DIGITAL CONTENT

Interview #SpeakPharma, Vlog #PharmaReel, Data Compilation #PharmaFlow, 6 News #PharmaBuzz

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

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

SERVICES

Drug Product Manufacturing, API & Drug Product Development

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

REF. STANDARDS & IMPURITIES

1 Others

1 Others

INSPECTIONS & REGISTRATIONS

5 FDA, 2 EDQM, 1 GDUFA

5 FDA
2 EDQM
1 GDUFA

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FILTER :

filter Legal Name Reset all filters

5 All

01 4Summit Biosciences Inc.

02 1Summit Biosciences LLC

filter District Decision Reset all filters

5 All

01 4No Action Indicated

02 1Voluntary Action Indicated

filter Inspection End Date Reset all filters

5 All

01 12025-02-21

02 12020-02-04

03 12017-06-23

04 12015-06-18

05 12014-02-28

filter City Reset all filters

5 All

01 5Lexington

filter Country/Area Reset all filters

5 All

01 5U.S.A

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

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 : 2025-02-21

Summit Biosciences

City : Lexington

State : Kentucky

Country/Area : U.S.A

Zip : 40511

District :

Center :

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2025-02-21

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

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 : Kentucky

Country/Area : U.S.A

Zip : 40511

District :

Center :

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

03

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

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 : Kentucky

Country/Area : U.S.A

Zip : 40511

District :

Center :

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

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

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 : Kentucky

Country/Area : U.S.A

Zip : 40511

District :

Center :

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

05

FDA Audited

USA

SCOPE Summit

Not Confirmed

FDA Audited

USA

SCOPE Summit

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 : U.S.A

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

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.