GDUFA
DMF Review : N/A
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DMF Number : 30411
Submission : 2016-02-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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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 :
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DMF Number : 27016
Submission : 2013-03-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 32000
Submission : 2017-08-23
Status : Active
Type : IV
GDUFA
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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
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DMF Number : 13065
Submission : 1998-07-15
Status : Active
Type : IV
GDUFA
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Rev. Date :
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DMF Number : 13156
Submission : 1998-08-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 23113
Submission : 2009-09-09
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 24142
Submission : 2010-09-14
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 10611
Submission : 1993-12-06
Status : Active
Type : IV
GDUFA
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DMF Number : 12627
Submission : 1997-08-21
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 12329
Submission : 1997-01-16
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 449
Submission : 1961-09-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 11198
Submission : 1994-11-11
Status : Active
Type : IV
GDUFA
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DMF Number : 6600
Submission : 1986-09-23
Status : Active
Type : IV
GDUFA
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DMF Number : 12150
Submission : 1996-10-04
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 6410
Submission : 1986-06-10
Status : Inactive
Type : II
GDUFA
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DMF Number : 11963
Submission : 1996-05-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12299
Submission : 1996-12-20
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
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 : Disintequik™ MCC 25
Application : Chewable & Orodispersible Aids
Excipient Details : Direct Tabletting Operations Where Fast Disintegration Is Required
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose Excipient
Application : Chewable & Orodispersible Aids
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 : Chewable & Orodispersible Aids
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
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