GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6244
Submission : 1986-04-03
Status : Active
Type : IV
Certificate Number : R1-CEP 2001-114 - Rev 04
Issue Date : 2021-04-09
Type : Chemical
Substance Number : 436
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
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3298
Submission : 1978-09-07
Status : Inactive
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : R1-CEP 2001-113 - Rev 02
Issue Date : 2019-12-05
Type : Chemical
Substance Number : 435
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6244
Submission : 1986-04-03
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3298
Submission : 1978-09-07
Status : Inactive
Type : IV
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Sorbitol, Liquid (crystallising)
Certificate Number : R1-CEP 2001-114 - Rev 04
Status : Valid
Issue Date : 2021-04-09
Type : Chemical
Substance Number : 436
Certificate Number : R1-CEP 2001-113 - Rev 02
Status : Valid
Issue Date : 2019-12-05
Type : Chemical
Substance Number : 435
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
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
About the Company : Tereos Syral is a leading European producer of starch-based pharmaceutical excipients and actives, used in solid and liquid dosage forms, medicated confectionery and clinical nutri...
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/USP, USP/FCC
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid crystallizing
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Brand Name : NEOSORB® 70/02 SB
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/USP
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid crystallizing
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : USP/FCC, EP/USP
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid crystallizing
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/NF
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid non crystallizing
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Brand Name : NEOSORB® 70/70 SB
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/NF
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid non crystallizing
Dosage Form : Capsule, Suspension, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : NF
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid non crystallizing
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Brand Name : ReadiLYCOAT® D CLEAR 110.01
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Dosage Form : Cream / Lotion / Ointment, Softgels
Grade : Oral and Topical
Category : Film Formers & Plasticizers
Application : Film Formers & Plasticizers
Brand Name : ReadiLYCOAT® D CLEAR 110.01 MS
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Stearic Acid
Brand Name : ReadiLYCOAT® D WHITE 010.01 MS
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Brand Name : POLYSORB® 85/70/00
Application : Film Formers & Plasticizers
Excipient Details : It is a plasticizer in soft capsules and orally dissolving films. It can be used in pharmaceutical dosage forms.
Pharmacopoeia Ref : EP/USP
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid, partially dehydrated
Brand Name : ReadiLYCOAT® D WHITE 010.01
Application : Film Formers & Plasticizers
Excipient Details : A natural inert polymer and ready-to-use coating system for fast aqueous film coating saves up to 50% or more time.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Pea Starch, Sorbitol, Titanium Dioxide, Stearic Acid
Application : Taste Masking
Pharmacopoeia Ref : Not Available
Technical Specs : Pharma Grade/Food Grade
Ingredient(s) : Sorbitol
Application : Taste Masking
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/USP, USP/FCC
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid crystallizing
Brand Name : NEOSORB® 70/02 SB
Application : Taste Masking
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/USP
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid crystallizing
Application : Taste Masking
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : USP/FCC, EP/USP
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid crystallizing
Application : Taste Masking
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/NF
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid non crystallizing
Brand Name : NEOSORB® 70/70 SB
Application : Taste Masking
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : EP/NF
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid non crystallizing
Application : Taste Masking
Excipient Details : Act as a bulk sweetener and vehicle in liquid dosage forms and as a humectant in semi solids.
Pharmacopoeia Ref : NF
Technical Specs : Not Available
Ingredient(s) : Sorbitol liquid non crystallizing
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