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Details of Cook Pharmica Llc.'s U.S. FDA Inspections. Original Data: FDA Inspection Database

Cook Pharmica LLC.
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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Cook Pharmica LLC.

VISIT THE VIRTUAL BOOTH, Contact Details

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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

SERVICES

Packaging, Analytical, API Manufacturing, Drug Product Manufacturing, API & Drug Product Development

Packaging
Analytical
- 1 Stability Studies
- 4 Analytical Testing Services
API Manufacturing
Drug Product Manufacturing
- 2 Injectable / Parenteral
API & Drug Product Development
- 2 API Development
- 4 Formulation Development

INSPECTIONS & REGISTRATIONS

6 FDA, 1 GDUFA

6 FDA
1 GDUFA

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FILTER :

filter Legal Name Reset all filters

6 All

01 6Cook Pharmica, LLC

filter District Decision Reset all filters

6 All

01 3No Action Indicated

02 3Voluntary Action Indicated

filter Inspection End Date Reset all filters

6 All

01 22017-05-19

02 12014-11-07

03 12013-10-25

04 12013-06-17

05 12011-12-15

filter City Reset all filters

6 All

01 6Bloomington

filter Country/Area Reset all filters

6 All

01 6US

FDA
GDUFA

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price-trend

01

FDA Audited

USA

Discovery on Target

Not Confirmed

FDA Audited

USA

Discovery on Target

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 : 2011-12-15

Cook Pharmica LLC.

City : Bloomington

State : IN

Country/Area : US

Zip : 47403-4828

District : DET

Center : CDRH

Project Area : Compliance: Devices

District Decision : No Action Indicated

Inspection End Date : 2011-12-15

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

Discovery on Target

Not Confirmed

FDA Audited

USA

Discovery on Target

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 : 2013-06-17

Cook Pharmica LLC.

City : Bloomington

State : IN

Country/Area : US

Zip : 47403-4828

District : DET

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2013-06-17

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

Discovery on Target

Not Confirmed

FDA Audited

USA

Discovery on Target

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 : 2013-10-25

Cook Pharmica LLC.

City : Bloomington

State : IN

Country/Area : US

Zip : 47403-4828

District : DET

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2013-10-25

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

Discovery on Target

Not Confirmed

FDA Audited

USA

Discovery on Target

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 : 2014-11-07

Cook Pharmica LLC.

City : Bloomington

State : IN

Country/Area : US

Zip : 47403-4828

District : DET

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2014-11-07

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

Discovery on Target

Not Confirmed

FDA Audited

USA

Discovery on Target

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 : 2017-05-19

Cook Pharmica LLC.

City : Bloomington

State : IN

Country/Area : US

Zip : 47403-4828

District : DET

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

Discovery on Target

Not Confirmed

FDA Audited

USA

Discovery on Target

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 : 2017-05-19

Cook Pharmica LLC.

City : Bloomington

State : IN

Country/Area : US

Zip : 47403-4828

District : DET

Center : CDRH

Project Area : Compliance: Devices

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-05-19

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

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