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 : 20568
Submission : 2007-05-10
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 : 38990
Submission : 2023-10-16
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

NDC Package Code : 51552-0136
Start Marketing Date : 1998-04-01
End Marketing Date : 2026-02-12
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING

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 : 24141
Submission : 2010-09-14
Status : Inactive
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 : 38990
Submission : 2023-10-16
Status : Active
Type : IV

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

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 51552-0136
Start Marketing Date : 1998-04-01
End Marketing Date : 2026-02-12
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT FOR HUMAN P...

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.
Pharmacopoeia Ref : DMF, EXCiPAT, KOSHER, HALAL, W...
Technical Specs : NA
Ingredient(s) : Lactose Monohydrate
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) : 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
MARKET PLACE
Reply
03 Dec 2025
Reply
28 Apr 2025
Reply
03 Jan 2025
Reply
28 Dec 2024
Reply
04 Nov 2024
Reply
24 Jun 2024
Reply
10 Jun 2024
Reply
08 Mar 2024
Reply
15 Jan 2024
Reply
17 Nov 2023
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
REF. STANDARDS & IMPURITIES
CAS Number : 64044-51-5
Quantity Per Vial : 500
Sale Unit : mg
Price : $290.00
Details : Material Origin- Animal-Cow; USMCA- No; KORUS...
Monograph :
Storage :
Code/Batch No : Catalog #1356701 / R084R0

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]