GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34077
Submission : 2019-08-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29049
Submission : 2015-02-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39750
Submission : 2024-03-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28407
Submission : 2014-06-12
Status : Active
Type : IV
Certificate Number : R1-CEP 2012-196 - Rev 01
Issue Date : 2019-11-22
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28892
Submission : 2014-12-03
Status : Active
Type : IV
Certificate Number : R1-CEP 2014-314 - Rev 01
Issue Date : 2023-05-09
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27417
Submission : 2013-08-14
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32698
Submission : 2018-11-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33415
Submission : 2018-12-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33592
Submission : 2019-02-21
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32695
Submission : 2018-03-27
Status : Active
Type : IV
Certificate Number : R1-CEP 2007-077 - Rev 02
Issue Date : 2017-01-30
Type : Chemical
Substance Number : 685
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 78
Submission : 1966-09-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11070
Submission : 1994-08-30
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30698
Submission : 2016-05-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29310
Submission : 2015-04-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29049
Submission : 2015-02-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27417
Submission : 2013-08-14
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28407
Submission : 2014-06-12
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30221
Submission : 2016-02-02
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28892
Submission : 2014-12-03
Status : Active
Type : IV
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 134
Submission : 1953-09-28
Status : Inactive
Type : II
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Product Web Link
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Corporate PDF
Povidone, 'Nominal K-value 12' and 'nominal K-value 17'
Certificate Number : R1-CEP 2007-077 - Rev 02
Status : Valid
Issue Date : 2017-01-30
Type : Chemical
Substance Number : 685
Povidone, 'Nominal K-value 25' and 'nominal K-value 30'
Certificate Number : R1-CEP 2007-079 - Rev 01
Status : Valid
Issue Date : 2017-02-09
Type : Chemical
Substance Number : 685
Povidone, 'Nominal K-value 90'
Certificate Number : R1-CEP 2007-078 - Rev 01
Status : Valid
Issue Date : 2017-01-30
Type : Chemical
Substance Number : 685
Certificate Number : R1-CEP 2017-024 - Rev 00
Status : Valid
Issue Date : 2023-07-10
Type : Chemical
Substance Number : 685
Povidone, K-12, K-17, K-25, K-30 and K-90
Certificate Number : R1-CEP 2012-196 - Rev 01
Status : Valid
Issue Date : 2019-11-22
Type : Chemical
Substance Number : 685
Certificate Number : R1-CEP 2014-314 - Rev 01
Status : Valid
Issue Date : 2023-05-09
Type : Chemical
Substance Number : 685
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Certificate Number : CEP 2023-207 - Rev 00
Status : Valid
Issue Date : 2024-03-01
Type : Chemical
Substance Number : 685
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
VMF Number : 78
Submission : 1971-03-24
Status : Inactive
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Fillers, Diluents & Binders
Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone
Application : Fillers, Diluents & Binders
Excipient Details : DiCOM-DC S604 is used as a DC co-processed excipient with a combination of various polymers that act as fillers and binders in tablets and capsules.
Pharmacopoeia Ref : In-house
Technical Specs : Polyvinyl Pyrrolidone 97% & 93%
Ingredient(s) : Polyvinyl pyrrolidone
Application : Fillers, Diluents & Binders
Excipient Details : Disintegrant; Dissolution enhancer; Suspending Agent, Tablet Binder.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Binder for peroxide sensitive drugs in solid oral dosage forms. Drug solubilizer with low peroxide in transdermal patches.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Application : Fillers, Diluents & Binders
Pharmacopoeia Ref : USP-NF, EP, BP, IP, JP, FCC
Technical Specs : PVP K-K-30/ K-17/ K19/ K25/ K90
Ingredient(s) : Povidone
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Fillers, Diluents & Binders
Application : Fillers, Diluents & Binders
Excipient Details : Tablet binding, thickener, stabilizers of suspensions, reduces sedimentation, crystallization inhibition.
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Application : Thickeners and Stabilizers
Pharmacopoeia Ref : USP-NF, EP, BP, IP, JP, FCC
Technical Specs : PVP K-K-30/ K-17/ K19/ K25/ K90
Ingredient(s) : Povidone
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17 Jan 2020
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