GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12966
Submission : 1998-02-03
Status : Active
Type : IV
Certificate Number : R1-CEP 2002-133 - Rev 01
Issue Date : 2020-10-28
Type : Chemical
Substance Number : 316
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12967
Submission : 1998-02-03
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13065
Submission : 1998-07-15
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13156
Submission : 1998-08-15
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30411
Submission : 2016-02-28
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20915
Submission : 2007-09-25
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-097 - Rev 01
Issue Date : 2020-12-04
Type : Chemical
Substance Number : 316
Status : Valid

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27016
Submission : 2013-03-12
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32000
Submission : 2017-08-23
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23113
Submission : 2009-09-09
Status : Inactive
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24142
Submission : 2010-09-14
Status : Inactive
Type : IV

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10611
Submission : 1993-12-06
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12627
Submission : 1997-08-21
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12329
Submission : 1997-01-16
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 449
Submission : 1961-09-18
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11198
Submission : 1994-11-11
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12150
Submission : 1996-10-04
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6600
Submission : 1986-09-23
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11963
Submission : 1996-05-09
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6410
Submission : 1986-06-10
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12299
Submission : 1996-12-20
Status : Active
Type : IV

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Certificate Number : R1-CEP 2007-321 - Rev 01
Status : Valid
Issue Date : 2014-08-07
Type : Chemical
Substance Number : 316

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Certificate Number : R1-CEP 2002-133 - Rev 01
Status : Valid
Issue Date : 2020-10-28
Type : Chemical
Substance Number : 316

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Certificate Number : R1-CEP 2016-301 - Rev 00
Status : Valid
Issue Date : 2022-12-20
Type : Chemical
Substance Number : 316

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Certificate Number : R1-CEP 2014-097 - Rev 01
Status : Valid
Issue Date : 2020-12-04
Type : Chemical
Substance Number : 316

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Digital Content
Website
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Certificate Number : CEP 2000-184 - Rev 04
Status : Valid
Issue Date : 2025-04-09
Type : Chemical
Substance Number : 316

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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Fillers, Diluents & Binders
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF,BP,EP,IP
Technical Specs : NA
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Fillers, Diluents & Binders
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF,BP,EP,IP
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Fillers, Diluents & Binders
Excipient Details : TABCELL serves as an excellent excipient for solid dosage forms, providing numerous advantages for tablet formulations.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Brand Name : Microcrystalline Cellulose
Application : Fillers, Diluents & Binders
Excipient Details : Microcrystalline Cellulose is most commonly used filler and binder in drug formulations, together with Lactose.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Fillers, Diluents & Binders
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Fillers, Diluents & Binders
Excipient Details : It is used as a filler in formulation.
Pharmacopoeia Ref : Not Available
Technical Specs : Also Available as Comprecel M102, M102CG, M103, M105, M124, M113,...
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : IP/BP/USP/EP
Technical Specs : NA
Ingredient(s) : Microcrystalline Cellulose Excipients
Brand Name : Microcrystalline Cellulose
Application : Fillers, Diluents & Binders
Excipient Details : Microcrystalline Cellulose is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Fillers, Diluents & Binders
Excipient Details : HiCel acts as a strong dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Direct Compression
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 440 g/l, Bulk density- 310 g/l; Particl...
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Direct Compression
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Direct Compression
Excipient Details : HiCel acts as a strong dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Direct Compression
Excipient Details : HiCel SMCC has unique combination which result in optimum compaction & superior flow properties.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Direct Compression
Excipient Details : HiCellac is used in direct compression & dry granulation suitable for low dose formulations where API content uniformity is critical.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Brand Name : Microlex® MCC 101
Application : Direct Compression
Excipient Details : Tablets made from these granules are typically easily disintegrated using conventional super disintegrates even when hard tablets are compressed.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Brand Name : Microlex® MCC 102
Application : Direct Compression
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Direct Compression
Excipient Details : HiCel HFE has superior compactibility, low sensitivity to lubrication & better disintegration properties. It is used in direct compression of ODTs.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Co-Processed Excipients
Excipient Details : ProBlend (SMCC) is a co-processed excipient consists of microcrystalline cellulose & colloidal silicon dioxide, used as a diluent & binder in OSDs.
Pharmacopoeia Ref : USP-NF,BP,EP,IP
Technical Specs : NA
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Co-Processed Excipients
Excipient Details : Microlose (Lactose Monohydrate & Microcrystalline Cellulose) is used as a diluent in oral dosage forms such as tablets.
Pharmacopoeia Ref : USP-NF,BP,EP,IP
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Co-Processed Excipients
Excipient Details : HiCel CE15 offers a superior mouthfeel with less chalkiness and gritness in chewable tablets and orally disintegrating tablets (ODTs).
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Brand Name : HiCel MCC Spheres
Application : Co-Processed Excipients
Excipient Details : HiCel MCC Spheres are extremely versatile which are used for controlled release or sustained release formulations.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Co-Processed Excipients
Excipient Details : HiCel SMCC has unique combination which result in optimum compaction & superior flow properties.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Co-Processed Excipients
Excipient Details : HiCel MCG is use in oral suspensions as a stabilizer. It is a good binder for tablets & excellent thickener as well.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Co-Processed Excipients
Excipient Details : HiCel HFE has superior compactibility, low sensitivity to lubrication & better disintegration properties. It is used in direct compression of ODTs.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Granulation
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Granulation
Excipient Details : HiCel acts as a strong dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Granulation
Pharmacopoeia Ref : EP./USP.NF
Technical Specs : NA
Ingredient(s) : Microcrystalline Cellulose Excipients
Application : Granulation
Excipient Details : HiCellac is used in direct compression & dry granulation suitable for low dose formulations where API content uniformity is critical.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
Brand Name : Microlex® MCC 101
Application : Granulation
Excipient Details : Tablets made from these granules are typically easily disintegrated using conventional super disintegrates even when hard tablets are compressed.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipients
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