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Industry Trade Show
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AIChE Annual MeetingAIChE Annual Meeting
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02-06 November, 2025
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03-06 November, 2025
Digital content
INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/we-re-expanding-our-cdmo-capabilities-to-meet-the-next-wave-of-complex-therapies-starting-with-oncology
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20 Oct 2025
// INDPHARMAPOST
https://www.indianpharmapost.com/rd/roquette-opens-health-and-pharma-solutions-innovation-center-in-brazil-18035

16 Oct 2025
// PHARMIWEB
https://www.pharmiweb.com/press-release/2025-10-16/new-roquette-pharmaceutical-innovation-center-to-strengthen-latin-america-as-collaborative-hub

25 Sep 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/09/25/3155964/0/en/H1-25-Results-Confirm-the-Relevance-of-Roquette-s-Strategy.html

23 Jul 2025
// CONTRACTPHARMA
https://www.contractpharma.com/breaking-news/roquette-launches-polyox-extended-stability-packaging/

05 Jun 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/06/05/3094692/0/en/Roquette-Appoints-Thierry-Fournier-as-Chief-Executive-Officer.html

05 May 2025
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2025/05/05/3073755/0/en/Roquette-Announces-a-New-Organization-following-the-Acquisition-of-IFF-Pharma-Solutions.html
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-01
Pay. Date : 2014-04-29
DMF Number : 4697
Submission : 1982-10-27
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2015-11-23
Pay. Date : 2015-01-05
DMF Number : 11059
Submission : 1994-09-01
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30897
Submission : 2016-08-29
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5443
Submission : 1984-06-29
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6650
Submission : 1986-10-29
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2013-07-31
Pay. Date : 2013-07-22
DMF Number : 12879
Submission : 1998-02-26
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37662
Submission : 2022-12-20
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34499
Submission : 2020-01-15
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5448
Submission : 1984-02-08
Status : Inactive
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2024-12-30
Pay. Date : 2024-09-05
DMF Number : 34930
Submission : 2020-06-09
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Certificate Numbers : R1-CEP 2015-264 - Rev 00
Status : Valid
Issue Date : 2022-04-04
Type : Chemical
Substance Number : 1804

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CEP/COS
Certificate Numbers : R0-CEP 2006-048 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2007-06-08
Type : Chemical
Substance Number : 2033

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 50516-003
Start Marketing Date : 2020-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

NDC Package Code : 50516-004
Start Marketing Date : 2020-08-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

Excipients
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : R1-CEP 1996-030 - Rev 04
Issue Date : 2015-12-21
Type :
Substance Number :
Status : Valid
Registration Number : 222MF10150
Registrant's Address : La Haute Loge LESTREM FRANCE
Initial Date of Registration : 2010-05-17
Latest Date of Registration :
NDC Package Code : 52647-001
Start Marketing Date : 2014-06-19
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14891
Submission : 2000-05-16
Status : Active
Type : IV
Certificate Number : R1-CEP 2000-039 - Rev 01
Issue Date : 2019-09-12
Type :
Substance Number :
Status : Valid
NDC Package Code : 50516-002
Start Marketing Date : 2014-05-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18143
Submission : 2005-03-08
Status : Active
Type : IV
Certificate Number : R1-CEP 2000-040 - Rev 02
Issue Date : 2019-09-12
Type :
Substance Number :
Status : Valid

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6244
Submission : 1986-04-03
Status : Active
Type : IV
Certificate Number : R1-CEP 2001-113 - Rev 02
Issue Date : 2019-12-05
Type :
Substance Number :
Status : Valid
NDC Package Code : 50516-005
Start Marketing Date : 2021-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16854
Submission : 2003-09-23
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23919
Submission : 2010-06-25
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23720
Submission : 2010-04-16
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12299
Submission : 1996-12-20
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30748
Submission : 2016-07-13
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23917
Submission : 2010-06-25
Status : Active
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9155
Submission : 1991-06-10
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32790
Submission : 2018-04-27
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31776
Submission : 2017-05-19
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3495
Submission : 1979-03-16
Status : Inactive
Type : II

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7651
Submission : 1988-08-22
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16854
Submission : 2003-09-23
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9420
Submission : 1991-11-22
Status : Active
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5656
Submission : 1984-11-05
Status : Inactive
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6611
Submission : 1986-10-02
Status : Inactive
Type : IV

Excipients Web Link
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32441
Submission : 2018-01-08
Status : Active
Type : IV

Excipients Web Link
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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Excipients Web Link

Certificate Numbers : R1-CEP 2009-307 - Rev 00
Status : Valid
Issue Date : 2017-02-13
Type : Chemical
Substance Number : 1070

Excipients Web Link
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Excipients Web Link

Certificate Numbers : R1-CEP 1996-030 - Rev 04
Status : Valid
Issue Date : 2015-12-21
Type : Chemical
Substance Number : 178

Excipients Web Link
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Excipients Web Link

Certificate Numbers : R1-CEP 2000-039 - Rev 01
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559

Excipients Web Link
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Excipients Web Link

Certificate Numbers : R1-CEP 2000-040 - Rev 02
Status : Valid
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559

Excipients Web Link
Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass.
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Excipients Web Link

Certificate Numbers : R1-CEP 2001-113 - Rev 02
Status : Valid
Issue Date : 2019-12-05
Type : Chemical
Substance Number : 435

Excipients Web Link
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Excipients Web Link

Certificate Numbers : R1-CEP 2001-114 - Rev 04
Status : Valid
Issue Date : 2021-04-09
Type : Chemical
Substance Number : 436

Excipients Web Link
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Ingredients
Dosage Form : Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Softgels, Suspension, Syrup, Tablet, Topical Film
Grade : Not Available
Application : Solubilizers, Taste Masking, Thickeners and Stabilizers
Excipient Details : Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Dosage Form : Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Softgels, Suspension, Syrup, Tablet, Topical Film
Grade : Not Available
Application : Solubilizers, Taste Masking, Thickeners and Stabilizers
Excipient Details : Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Dosage Form : Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Softgels, Suspension, Syrup, Tablet, Topical Film
Grade : Not Available
Application : Solubilizers, Taste Masking, Thickeners and Stabilizers
Excipient Details : Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Dosage Form : Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Softgels, Suspension, Syrup, Tablet, Topical Film
Grade : Not Available
Application : Solubilizers, Taste Masking, Thickeners and Stabilizers
Excipient Details : Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Dosage Form : Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Softgels, Suspension, Syrup, Tablet, Topical Film
Grade : Not Available
Application : Solubilizers, Taste Masking, Thickeners and Stabilizers
Excipient Details : Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
Dosage Form : Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Softgels, Suspension, Syrup, Tablet, Topical Film
Grade : Not Available
Application : Solubilizers, Taste Masking, Thickeners and Stabilizers
Excipient Details : Beta-cyclodextrins are efficient solubilizers, stabilization enhancers and taste-masking agents.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Dosage Form : Injectable / Parenteral
Grade : Not Available
Application : Parenteral
Excipient Details : These are parenteral grade materials that are used as encapsulating agents for Rx injectables
Pharmacopoeia Ref : USP/EP
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Betacyclodextrin
Dosage Form : Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Softgels, Suspension, Syrup, Tablet
Grade : Not Available
Application : Solubilizers, Taste Masking, Thickeners and Stabilizers
Excipient Details : It improves the solubility of poorly soluble compounds and can be used for taste masking of unpleasant active ingredients.
Pharmacopoeia Ref : EP/USP
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Betacyclodextrin
Dosage Form : Injectable / Parenteral
Grade : Not Available
Application : Parenteral
Excipient Details : These are parenteral grade materials that are used as encapsulating agents for Rx injectables
Pharmacopoeia Ref : USP/EP
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Betacyclodextrin
Dosage Form : Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Softgels, Suspension, Syrup, Tablet
Grade : Not Available
Application : Solubilizers, Taste Masking, Thickeners and Stabilizers
Excipient Details : It improves the solubility of poorly soluble compounds and can be used for taste masking of unpleasant active ingredients.
Pharmacopoeia Ref : EP/USP
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Betacyclodextrin
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients By applications
Inspections and registrations
ABOUT THIS PAGE
Roquette is a supplier offers 14 products (APIs, Excipients or Intermediates).
Find a price of Hydroxypropyl-Beta Cyclodextrin bulk with DMF, CEP offered by Roquette
Find a price of Polydextrose bulk with DMF, JDMF offered by Roquette
Find a price of Dextrose Monohydrate API bulk with DMF offered by Roquette
Find a price of Glucose bulk with DMF offered by Roquette
Find a price of Isosorbide bulk with JDMF offered by Roquette
Find a price of Mannitol API bulk with DMF offered by Roquette
Find a price of Sodium Gluconate bulk with DMF offered by Roquette
Find a price of Sorbitol API bulk with DMF offered by Roquette
Find a price of Mannitol API bulk offered by Roquette
Find a price of Sodium Lactate bulk offered by Roquette
Find a price of SODIUM STARCH GLYOLATE bulk offered by Roquette
Find a price of MANUFACTURING SITE,FACILITIES,PERSONNEL AND GENERAL OPERATING PROCEDURES IN LESTREM,FRANCE. bulk offered by Roquette
Find a price of Adrabetadex bulk offered by Roquette
Find a price of Icodextrin bulk offered by Roquette