GDUFA
DMF Review : N/A
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DMF Number : 32957
Submission : 2018-07-18
Status : Active
Type : IV
GDUFA
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DMF Number : 37688
Submission : 2022-11-12
Status : Active
Type : IV

GDUFA
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DMF Number : 20568
Submission : 2007-05-10
Status : Active
Type : IV

GDUFA
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DMF Number : 28498
Submission : 2014-05-23
Status : Active
Type : IV

GDUFA
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DMF Number : 38990
Submission : 2023-10-16
Status : Active
Type : IV

GDUFA
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DMF Number : 37267
Submission : 2022-09-15
Status : Active
Type : IV

GDUFA
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DMF Number : 21598
Submission : 2008-05-07
Status : Inactive
Type : IV

GDUFA
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DMF Number : 24141
Submission : 2010-09-14
Status : Inactive
Type : IV

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32957
Submission : 2018-07-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37267
Submission : 2022-09-15
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37688
Submission : 2022-11-12
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21598
Submission : 2008-05-07
Status : Inactive
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24141
Submission : 2010-09-14
Status : Inactive
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38990
Submission : 2023-10-16
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28498
Submission : 2014-05-23
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20568
Submission : 2007-05-10
Status : Active
Type : IV

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 : Starlose P40 (Starch & Lactose Monohydrate) is used as a diluent in oral dosage forms such as tablets.
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) : Lactose Monohydrate
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 857 g/l, Bulk density- 589 g/l; Particle...
Ingredient(s) : Lactose Monohydrate
Excipients Web Link
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 716 g/l, Bulk density- 599 g/l; Particle...
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Monohydrate Capsulating Grade
Application : Fillers, Diluents & Binders
Excipient Details : Filler, Diluent, & Bulking Agent In A Wide Variety Of Pharmaceutical Tablets, Capsules, Powders, And Other Preparations
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Monohydrate 200 M
Application : Fillers, Diluents & Binders
Excipient Details : Filler, Diluent, & Bulking Agent In A Wide Variety Of Pharmaceutical Tablets, Capsules, Powders, And Other Preparations
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Monohydrate 80M
Application : Fillers, Diluents & Binders
Excipient Details : Filler, Diluent, & Bulking Agent In A Wide Variety Of Pharmaceutical Tablets, Capsules, Powders, And Other Preparations
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Monohydrate Impalpable
Application : Fillers, Diluents & Binders
Excipient Details : Filler, Diluent, & Bulking Agent In A Wide Variety Of Pharmaceutical Tablets, Capsules, Powders, And Other Preparations
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Monohydrate 313
Application : Granulation
Excipient Details : Wet Granulation & Capsule Filling
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Application : Granulation
Pharmacopoeia Ref : Conforms to USP-NF, Ph.Eur., J...
Technical Specs : Density- Tapped density- 857 g/l, Bulk density- 589 g/l; Particle...
Ingredient(s) : Lactose Monohydrate
Excipients Web Link
Brand Name : Sheffield™ Monohydrate 310
Application : Granulation
Excipient Details : Wet Granulation & Capsule Filling
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Monohydrate 312
Application : Granulation
Excipient Details : Wet Granulation & Capsule Filling
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
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) : Lactose Monohydrate
Brand Name : Microlex® LCM 80.m
Application : Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Milled; Also Available as Microlex® LCM 180.m, Microlex® LCM 20...
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® LCM 120.s
Application : Granulation
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Sieved; Also Available as Microlex® LCM 180.s, Microlex® LCM 22...
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Spray Dried 316 Fast Flo®
Application : Direct Compression
Excipient Details : Pharmaceutical excipient used in direct compression
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Sheffield™ Spray Dried 315
Application : Direct Compression
Excipient Details : Pharmaceutical excipient used in direct compression
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
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) : Lactose Monohydrate
Brand Name : Microlex® LCM 80.m
Application : Direct Compression
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Milled; Also Available as Microlex® LCM 180.m, Microlex® LCM 20...
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® LCM 120.s
Application : Direct Compression
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Sieved; Also Available as Microlex® LCM 180.s, Microlex® LCM 22...
Ingredient(s) : Lactose Monohydrate
MARKET PLACE
REF. STANDARDS & IMPURITIES