GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28696
Submission : 2014-09-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34493
Submission : 2020-03-19
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36518
Submission : 2021-12-14
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28074
Submission : 2014-03-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39732
Submission : 2024-04-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32603
Submission : 2018-03-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28266
Submission : 2014-05-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10958
Submission : 1994-06-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36749
Submission : 2022-01-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33778
Submission : 2019-04-12
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9557
Submission : 1992-02-21
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25838
Submission : 2012-02-29
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20329
Submission : 2007-03-06
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10958
Submission : 1994-06-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28074
Submission : 2014-03-05
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16190
Submission : 2002-10-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15712
Submission : 2001-11-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28266
Submission : 2014-05-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32603
Submission : 2018-03-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30976
Submission : 2016-09-20
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Brand Name : Innogel 9000/9500
Application : Fillers, Diluents & Binders
Excipient Details : Innogel 9000/9500 (Pregelatinized Starch) is used as filler, binder, disintegrant, and superdisintegrant in tablets and capsules.
Pharmacopoeia Ref : IP/BP/EP/USP-NF
Technical Specs : NA
Ingredient(s) : Corn Starch, Pregelatinized
Application : Fillers, Diluents & Binders
Excipient Details : Fully Pregel Starch Corn is used as a binder in wet granulation in the manufacturing of tablets.
Pharmacopoeia Ref : USP/NF, Ph. Eur., Ch. P.
Technical Specs : NA
Ingredient(s) : Corn Starch, Pregelatinized
Application : Fillers, Diluents & Binders
Excipient Details : It is used as a filler in formulation.
Application : Fillers, Diluents & Binders
Excipient Details : Tablet and capsule diluent, tablet and capsule disintegrant and tablet binder.
Application : Direct Compression
Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.
Application : Direct Compression
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170, Taped Density: 0.80
Ingredient(s) : Starch
Application : Direct Compression
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175, Tapped Density: 0.85
Ingredient(s) : Starch
Application : Direct Compression
Excipient Details : Capsule Filling, Direct Compression, Binding, Disintegration
Pharmacopoeia Ref : Not Available
Technical Specs : EXCiPACT
Ingredient(s) : Native & Pregelatinized Corn Starch
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