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 : 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 : 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
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 : 6600
Submission : 1986-09-23
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 : 6410
Submission : 1986-06-10
Status : Inactive
Type : II
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 : 11198
Submission : 1994-11-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9201
Submission : 1991-06-17
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-321 - Rev 01
Status : Valid
Issue Date : 2014-08-07
Type : Chemical
Substance Number : 316
Certificate Number : R1-CEP 2002-133 - Rev 01
Status : Valid
Issue Date : 2020-10-28
Type : Chemical
Substance Number : 316
Certificate Number : R1-CEP 2016-301 - Rev 00
Status : Valid
Issue Date : 2022-12-20
Type : Chemical
Substance Number : 316
Certificate Number : R1-CEP 2014-097 - Rev 01
Status : Valid
Issue Date : 2020-12-04
Type : Chemical
Substance Number : 316
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2000-184 - Rev 04
Status : Valid
Issue Date : 2025-04-09
Type : Chemical
Substance Number : 316
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FINISHED DOSAGE FORMULATIONS
Drug : FLOMAX
Dosage Form : CAPSULE; ORAL
Application Number : 20579
Country : US
Patented : No
Drug : AMARYL
Dosage Form : TABLET; ORAL
Application Number : 20496
Country : US
Patented : No
Drug : KETEK
Dosage Form : TABLET; ORAL
Application Number : 21144
Country : US
Patented : No
Drug : DIABETA
Dosage Form : TABLET; ORAL
Application Number : 17532
Country : US
Patented : No
Drug : PRIFTIN
Dosage Form : TABLET; ORAL
Application Number : 21024
Country : US
Patented : No
Drug : CANTIL
Dosage Form : SOLUTION; ORAL
Application Number : 10679
Country : US
Patented : No
Drug : PLAVIX
Dosage Form : TABLET; ORAL
Application Number : 20839
Country : US
Patented : No
Drug : CANTIL
Dosage Form : TABLET; ORAL
Application Number : 10679
Country : US
Patented : No
HYDROCHLOROTHIAZIDE; IRBESARTAN
Drug : AVALIDE
Dosage Form : TABLET; ORAL
Application Number : 20758
Country : US
Patented : No
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, DMF, EXCiPAT, KOSHER, ...
Technical Specs : NA
Ingredient(s) : Silicified Microcrystalline Cellulose
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 : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : Lactose Monohydrate – 40%, Microcrystalline cellulose – 60%
Ingredient(s) : Microcrystalline Cellulose
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
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
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
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
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
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
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
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
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
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
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
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
Brand Name : Microlex® MCC 102
Application : Direct Compression
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
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
Brand Name : Microcrystalline Cellulose
Application : Disintegrants & Superdisintegrants
Excipient Details : Tablet and capsule diluent, Tablet disintegrant.
Pharmacopoeia Ref : USP/BP/EP/CP
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Disintegrants & Superdisintegrants
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
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Disintegrants & Superdisintegrants
Application : Disintegrants & Superdisintegrants
Excipient Details : F-Melt Type M is used in various dosage forms like orally disintegrating tablets (ODTs), sachets, dispersible tablets, chewable tablets and sublingual formulations.
Pharmacopoeia Ref : Conforms to Japanese Pharmaceu...
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Category : Disintegrants & Superdisintegrants
Application : Disintegrants & Superdisintegrants
Excipient Details : F-Melt Type C is a pharmaceutical excipient used in oral dosage forms like orally disintegrating tablets, sachets, dispersible tablets, chewable tablets and sublingual tablets.
Pharmacopoeia Ref : Conforms to Japanese Pharmaceu...
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Taste Masking
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
Application : Taste Masking
Excipient Details : F-Melt Type C is a pharmaceutical excipient used in oral dosage forms like orally disintegrating tablets, sachets, dispersible tablets, chewable tablets and sublingual tablets.
Pharmacopoeia Ref : Conforms to Japanese Pharmaceu...
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Application : Coating Systems & Additives
Excipient Details : Ready mix Film coating system for moisture sensitive APIs
Pharmacopoeia Ref : USP, EP, JP; Having US-DMF
Technical Specs : Moisture barrier film coating system
Ingredient(s) : Microcrystalline Cellulose
https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination
08 Mar 2023
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-march-8-2023-15780.pdf
29 Sep 2021
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-september-29-2021-1632907538.pdf
25 Aug 2021
// FDA
https://www.pharmacompass.com/pdf/news/enforcement-report-week-of-august-25-2021-1629867988.pdf
MARKET PLACE
Reply
30 Sep 2021
Reply
04 Sep 2018
Reply
27 May 2025
Reply
03 May 2025
Reply
15 Apr 2025
Reply
28 Mar 2025
Reply
27 Dec 2024
Reply
10 Dec 2024
Reply
04 Nov 2024
Reply
15 Jul 2024
Reply
10 Feb 2024
Reply
14 Oct 2023