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 : 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 : 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 : 39750
Submission : 2024-03-27
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
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Status : Withdrawn by Holder
Issue Date : 2017-01-30
Type : Chemical
Substance Number : 685
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
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 : CEP 2023-207 - Rev 00
Status : Valid
Issue Date : 2024-03-01
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
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Solubilizers
Excipient Details : Disintegrant; Dissolution enhancer; Suspending Agent, Tablet Binder.
Brand Name : Microlex® PVD K30
Application : Solubilizers
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Also Available as Microlex® PVD K90.
Ingredient(s) : Povidone
Application : Solubilizers
Pharmacopoeia Ref : USP-NF, EP, BP, IP, JP, FCC
Technical Specs : PVP K-K-30/ K-17/ K19/ K25/ K90
Ingredient(s) : Povidone
Application : Solubilizers
Excipient Details : Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
Application : Solubilizers
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
Dosage Form : Capsule, Emulsion, Softgel Capsule, Solution, Tablet, Transdermal patches
Grade : Not Available
Category : Solubilizers
Application : Solubilizers
Excipient Details : Solubilizing matrix, crystallization inhibitor & stabilizer in injectables and ophthalmic products
Pharmacopoeia Ref : Ph. Eur., USP: Povidone; JPE: ...
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Capsule, Emulsion, Granule / Pellet, Softgel Capsule, Solution, Tablet, Transdermal patches
Grade : Not Available
Category : Solubilizers
Application : Solubilizers
Excipient Details : Solubilizing matrix, crystallization inhibitor & stabilizer in injectables and ophthalmic products
Dosage Form : Capsule, Tablet, Topical Film, Transdermal Patch
Grade : Not Available
Category : Controlled & Modified Release
Application : Controlled & Modified Release
Excipient Details : For non-erodible matrices using direct compression, Controlled release matrix. Matrix former in transdermal patches and topical films.
Pharmacopoeia Ref : Ph. Eur., USP-NF, JP-JPE: 80 %...
Technical Specs : Not Available
Ingredient(s) : Povidone
Dosage Form : Capsule, Tablet, Transdermal Patch
Grade : Not Available
Category : Controlled & Modified Release
Application : Controlled & Modified Release
Excipient Details : Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
Dosage Form : Capsule, Tablet, Transdermal Patch
Grade : Not Available
Category : Controlled & Modified Release
Application : Controlled & Modified Release
Excipient Details : Solubilization, dispersion, crystallization inhibition, instant release matrices & spray drying
Pharmacopoeia Ref : Ph. Eur., USP, JP: Povidone
Technical Specs : Not Available
Ingredient(s) : Povidone
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REF. STANDARDS & IMPURITIES
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