Roquette | CEP/COS | Details of Certificates of Suitability | Excipients | Pharmacompass.com

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Roquette
CEP/COS

Veranova: A CDMO that manages complexity with confidence.

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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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xyz-pharma-m-2024-10-07

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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

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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
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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, 16 NEWS #PharmaBuzz

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

ACTIVE PHARMA INGREDIENTS

13 All APIs, 11 USDMF, 2 CEP/COS, 2 JDMF, 1 KDMF, 2 NDC API

13 All APIs
11 USDMF
2 CEP/COS
2 JDMF
1 KDMF
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, Maltodextrin Excipient, Corn Syrup, Dried Corn Glucose Syrup, Dextrose Monohydrate, Dried Maltitol Syrup, Dried Glucose Syrup, Beta-Cyclodextrin, Starch, Sodium Starch Glycolate, Hydroxypropyl Betacyclodextrin, Dextrose, Stearic Acid, Gluconate Sodium, Pea Protein, Croscarmellose Sodium, Glucono d lactone, Potato Starch, Lactose, High Fructose Corn Syrup, Titanium Dioxide, Carrageenan, Corn Starch

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

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

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filter Substance Reset all filters

6 All

01 1Betadex

02 1Glucose monohydrate, for use in the manufacture of parenteral preparations

03 1Mannitol

04 1Mannitol, Spray dried

05 1Sorbitol

06 1Sorbitol, liquid (crystallising)

filter Certificate Holder Reset all filters

6 All

01 6Roquette Frères Lestrem FR

filter Country Reset all filters

6 All

01 6France

filter Status Reset all filters

6 All

01 6Valid

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Roquette

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Digital Content

Betadex

Excipients Web Link

Certificate Holder

Roquette Frères Lestre...

Status

Valid

Certificate Number

R1-CEP 2009-307 - Rev 00

Type

Chemical

Issue Date

2017-02-13

End Date

Substance Number

1070

01

Betadex

CPHI Middle east

Not Confirmed

Betadex

CPHI Middle east

Not Confirmed

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Digital Content

Certificate Numbers : R1-CEP 2009-307 - Rev 00

Status : Valid

Issue Date : 2017-02-13

Type : Chemical

Substance Number : 1070

Excipients Web Link

Roquette

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Digital Content

Glucose monohydrate, for use in the manufacture of pare...

Excipients Web Link

Certificate Holder

Roquette Frères Lestre...

Status

Valid

Certificate Number

R1-CEP 1996-030 - Rev 04

Type

Chemical

Issue Date

2015-12-21

End Date

Substance Number

178

02

Glucose monohydrate, for use in the manu...

CPHI Middle east

Not Confirmed

Glucose monohydrate, for use in the manu...

CPHI Middle east

Not Confirmed

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Digital Content

Certificate Numbers : R1-CEP 1996-030 - Rev 04

Status : Valid

Issue Date : 2015-12-21

Type : Chemical

Substance Number : 178

Excipients Web Link

Roquette

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Digital Content

Mannitol

Excipients Web Link

Certificate Holder

Roquette Frères Lestre...

Status

Valid

Certificate Number

R1-CEP 2000-039 - Rev 01

Type

Chemical

Issue Date

2019-09-12

End Date

Substance Number

559

03

Mannitol

CPHI Middle east

Not Confirmed

Mannitol

CPHI Middle east

Not Confirmed

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Digital Content

Certificate Numbers : R1-CEP 2000-039 - Rev 01

Status : Valid

Issue Date : 2019-09-12

Type : Chemical

Substance Number : 559

Excipients Web Link

Roquette

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Digital Content

Mannitol, Spray dried

Excipients Web Link

Certificate Holder

Roquette Frères Lestre...

Status

Valid

Certificate Number

R1-CEP 2000-040 - Rev 02

Type

Chemical

Issue Date

2019-09-12

End Date

Substance Number

559

04

Mannitol, Spray dried