GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36420
Submission : 2021-11-23
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13969
Submission : 1999-01-29
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Application : Direct Compression
Excipient Details : KoVidone® VA64 is used as a binder in tablets, direct compression binder, matrix formers in amorphous solid dispersions, and film-forming polymer.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone and Vinyl Acetate Copolymer
Brand Name : KoVidone® Ultra VA64
Application : Direct Compression
Excipient Details : KoVidone® Ultra VA64 is used as a tablet binder, direct compression binder, matrix former in amorphous solid dispersions, and film-forming polymer.
Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP
Technical Specs : NA
Ingredient(s) : Polyvinylpyrrolidone and Vinyl Acetate Copolymer
Brand Name : Kollidon VA64 Fine
Application : Direct Compression
Excipient Details : Binder with fine particle size for roller compaction & direct compression
Pharmacopoeia Ref : Ph. Eur., USP monograph "Copov...
Technical Specs : Not Available
Ingredient(s) : Vinylpyrrolidone-Vinyl Acetate Copolymer
Application : Direct Compression
Pharmacopoeia Ref : Ph. Eur., USP monograph "Copov...
Technical Specs : Not Available
Ingredient(s) : Vinylpyrrolidone-Vinyl Acetate
MARKET PLACE
REF. STANDARDS & IMPURITIES