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

Roquette
FDA

Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

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As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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xyz-pharma-m-2024-10-07

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Evonik

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Gensenta is a trusted CDMO partner with robust history, commitment to quality, innovative mindset and commitment to sustainability.

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xyz-pharma-m-2024-10-07

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Roquette

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

PRESENTATION(s)

Product List 2022, Roquette Fact Sheet

Product List 2022
Roquette Fact Sheet

DIGITAL CONTENT

INTERVIEW #SpeakPharma, VLOG #PharmaReel, DATA COMPILATION #PharmaFlow, 15 NEWS #PharmaBuzz

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

ACTIVE PHARMA INGREDIENTS

13 All APIs, 11 USDMF, 2 CEP/COS, 2 JDMF, 2 NDC API

13 All APIs
11 USDMF
2 CEP/COS
2 JDMF
2 NDC API

EXCIPIENTS

28 All Excipients, 24 USDMF, 6 CEP/COS, 2 JDMF, 4 NDC API, 133 Listed Products

28 All Excipients
24 USDMF
6 CEP/COS
2 JDMF
4 NDC API
133 Listed Products

EXCIPIENTS BY INGREDIENTS

Sorbitol, Microcrystalline Cellulose, Pea Starch, Mannitol, Corn Syrup, Dried Corn Glucose Syrup, Maltodextrin Excipient, Dextrose Monohydrate, Dried Maltitol Syrup, Dried Glucose Syrup, Beta-Cyclodextrin, Starch, Sodium Starch Glycolate, Hydroxypropyl Betacyclodextrin, Dextrose, Stearic Acid, Pea Protein, Croscarmellose Sodium, Glucono d lactone, Gluconate Sodium, High Fructose Corn Syrup, Titanium Dioxide, Carrageenan, Corn Starch, Potato Starch, Lactose

Sorbitol
Microcrystalline Cellulose
Pea Starch
Mannitol
Corn Syrup, Dried Corn Glucose Syrup
Maltodextrin Excipient
Dextrose Monohydrate
Dried Maltitol Syrup
Dried Glucose Syrup
Beta-Cyclodextrin
Starch
Sodium Starch Glycolate
Hydroxypropyl Betacyclodextrin
Dextrose
Stearic Acid
Pea Protein
Croscarmellose Sodium
Glucono d lactone
Gluconate Sodium
High Fructose Corn Syrup
Titanium Dioxide
Carrageenan
Corn Starch
Potato Starch
Lactose

EXCIPIENTS BY APPLICATIONS

Fillers, Diluents & Binders, Taste Masking, Thickeners and Stabilizers, Film Formers & Plasticizers, Coating Systems & Additives, Disintegrants & Superdisintegrants, Parenteral, Solubilizers, Granulation, Chewable & Orodispersible Aids, Co-Processed Excipients, Soft Gelatin

Fillers, Diluents & Binders
Taste Masking
Thickeners and Stabilizers
Film Formers & Plasticizers
Coating Systems & Additives
Disintegrants & Superdisintegrants
Parenteral
Solubilizers
Granulation
Chewable & Orodispersible Aids
Co-Processed Excipients
Soft Gelatin

INSPECTIONS & REGISTRATIONS

13 FDA, 4 EDQM, 1 GDUFA

13 FDA
4 EDQM
1 GDUFA

Xls

Filters

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FILTER :

filter Legal Name Reset all filters

13 All

01 2Roquette

02 1Roquette America Corp.

03 7Roquette America, Inc.

04 3Roquette Freres

filter District Decision Reset all filters

13 All

01 11No Action Indicated

02 2Voluntary Action Indicated

filter Inspection End Date Reset all filters

13 All

01 12018-10-30

02 22018-09-21

03 12017-12-12

04 12017-02-10

05 12016-08-03

06 12015-05-29

07 12013-04-22

08 12012-10-23

09 22012-03-07

10 12011-11-09

11 12010-04-01

filter City Reset all filters

13 All

01 2Cassano Spinola

02 1Geneva

03 1Gurnee

04 4Keokuk

05 2La Harpe

06 3Lestrem

filter Country/Area Reset all filters

13 All

01 3FR

02 2IT

03 8US

FDA
EDQM
GDUFA

Supplier Virtual Booth

price-trend

01

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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 : 2015-05-29

City : Lestrem

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2015-05-29

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

02

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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 : 2017-02-10

City : Lestrem

State :

Country/Area : FR

Zip :

District : ORA

Center : CDER

Project Area : Drug Quality Assurance

District Decision : Voluntary Action Indicated

Inspection End Date : 2017-02-10

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

03

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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 : 2018-09-21

City : Cassano Spinola

State :

Country/Area : IT

Zip :

District : ORA

Center : CFSAN

Project Area : Foodborne Biological Hazards

District Decision : No Action Indicated

Inspection End Date : 2018-09-21

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

04

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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 : 2016-08-03

City : Keokuk

State : IA

Country/Area : US

Zip : 52632-5463

District : KAN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2016-08-03

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

05

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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 : 2012-03-07

City : Keokuk

State : IA

Country/Area : US

Zip : 52632-5463

District : KAN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2012-03-07

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

06

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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 : 2012-03-07

City : Keokuk

State : IA

Country/Area : US

Zip : 52632-5463

District : KAN

Center : CFSAN

Project Area : Foodborne Biological Hazards

District Decision : No Action Indicated

Inspection End Date : 2012-03-07

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow

07

FDA Audited

USA

BioJapan 2024

Not Confirmed

FDA Audited

USA

BioJapan 2024

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 : 2010-04-01

City : Keokuk

State : IA

Country/Area : US

Zip : 52632-5463

District : KAN

Center : CDER

Project Area : Drug Quality Assurance

District Decision : No Action Indicated

Inspection End Date : 2010-04-01

Product
Web Link

Stock Recap
#PipelineProspector

Data Compilation
#PharmaFlow