GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12524
Submission : 1997-06-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14031
Submission : 1999-03-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12900
Submission : 1998-03-17
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17578
Submission : 2004-07-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14765
Submission : 2000-03-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26653
Submission : 2012-09-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27914
Submission : 2014-01-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15212
Submission : 2000-12-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24926
Submission : 2011-05-04
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25333
Submission : 2011-09-16
Status : Active
Type : IV
Hypromellose, E50, 2910, 50 mPa.s
Certificate Number : R0-CEP 2017-299 - Rev 00
Status : Expired
Issue Date : 2019-09-20
Type : Chemical
Substance Number : 348
Hypromellose, 2208, 2906, 2910
Certificate Number : R1-CEP 2012-106 - Rev 00
Status : Valid
Issue Date : 2018-06-26
Type : Chemical
Substance Number : 348
Certificate Number : R1-CEP 2000-006 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2011-01-05
Type : Chemical
Substance Number : 348
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Controlled & Modified Release
Excipient Details : Film Forming Agent, Wet/Dry Granulation- Binder,Thickening & Suspension Agent, Non-Gelatin Capsule Manufacturing & Enteric Film Coating Systems
Pharmacopoeia Ref : USP, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Application : Controlled & Modified Release
Excipient Details : Sustained Release Tablet Matrix
Pharmacopoeia Ref : USP, EP, and JP
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Application : Controlled & Modified Release
Excipient Details : Instamodel Blend is used to provide Extended Release from the dosage form.
Application : Controlled & Modified Release
Excipient Details : Immediate Release
Pharmacopoeia Ref : Customized per requirements
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Brand Name : SheffCoat™Enhance
Application : Controlled & Modified Release
Excipient Details : Immediate Release
Pharmacopoeia Ref : Customized per requirements
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Application : Controlled & Modified Release
Excipient Details : Controlled Release, Direct Compression,Wet Granulation,Tablet Coating, Liquid Solutions and Suspensions
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Application : Controlled & Modified Release
Excipient Details : Immediate Release
Pharmacopoeia Ref : Customized per requirements
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Application : Controlled & Modified Release
Excipient Details : Immediate Release
Pharmacopoeia Ref : Customized per requirements
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
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