GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23703
Submission : 2010-04-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24006
Submission : 2010-07-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24399
Submission : 2010-11-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30189
Submission : 2016-01-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31077
Submission : 2016-10-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32980
Submission : 2018-07-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14823
Submission : 2000-04-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22662
Submission : 2009-03-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29965
Submission : 2015-10-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29457
Submission : 2015-03-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14823
Submission : 2000-04-11
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29965
Submission : 2015-10-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22662
Submission : 2009-03-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32980
Submission : 2018-07-10
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29457
Submission : 2015-03-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23703
Submission : 2010-04-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30189
Submission : 2016-01-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24399
Submission : 2010-11-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24006
Submission : 2010-07-25
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31077
Submission : 2016-10-09
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Brand Name : EUDRAGIT® L 100-55
Application : Coating Systems & Additives
Excipient Details : EUDRAGIT® L 100-55 (powder) is used in delayed release coatings to enhance solubility of poorly soluble drugs such as tablets, capsules & granules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Brand Name : EUDRAGIT® L 30 D-55
Application : Coating Systems & Additives
Excipient Details : EUDRAGIT® L 30 D-55 (aqueous dispersion) is a delayed release polymer used as coating and film former in tablets, capsules, granules etc.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Coating Systems & Additives
Excipient Details : Acrycoat L100 is used as an enteric coated Drug delivery system.
Pharmacopoeia Ref : USP/NF: Methacrylic Acid Copol...
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid Copolymer Type A
Brand Name : Lumacril L-100D 55
Application : Coating Systems & Additives
Excipient Details : Lumacril L-100D 55 is an anionic copolymer used in delayed & sustained release coatings to enhance solubility for poorly soluble drugs in OSDs.
Pharmacopoeia Ref : USP-NF, Ph.Eur, BP, JP
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Coating Systems & Additives
Excipient Details : Ecopol L 30 D-55 is used as an enteric/delayed release coating system for drug delivery in the duodenum.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Coating Systems & Additives
Excipient Details : Acrycoat L100D is used as an enteric coated Drug delivery system.
Pharmacopoeia Ref : USP/NF: Methacrylic Acid Copol...
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid Copolymer Type C
Application : Coating Systems & Additives
Excipient Details : Ecopol L100 55 is an enteric/delayed release coating for drug delivery in the duodenum.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Coating Systems & Additives
Excipient Details : Acrycoat L30D is used as an enteric coated Drug delivery system.
Pharmacopoeia Ref : Ph.Eur.: Methacrylic Acid - Et...
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A
Brand Name : Instacoat EN Super II
Application : Coating Systems & Additives
Excipient Details : Instacoat EN Super II is a fully formulated enteric coating system based on Methacrylic Acid Copolymer Type C.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid Copolymer Type C
Brand Name : Instacoat EN Super IV
Application : Coating Systems & Additives
Excipient Details : Instacoat EN Super IV is a fully formulated enteric coating system which provides reproducible delayed release profiles.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Brand Name : EUDRAGIT® L 100-55
Application : Controlled & Modified Release
Excipient Details : EUDRAGIT® L 100-55 (powder) is used in delayed release coatings to enhance solubility of poorly soluble drugs such as tablets, capsules & granules.
Pharmacopoeia Ref : NA
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Brand Name : Lumacril L-100D 55
Application : Controlled & Modified Release
Excipient Details : Lumacril L-100D 55 is an anionic copolymer used in delayed & sustained release coatings to enhance solubility for poorly soluble drugs in OSDs.
Pharmacopoeia Ref : USP-NF, Ph.Eur, BP, JP
Technical Specs : NA
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Controlled & Modified Release
Excipient Details : Ecopol L 30 D-55 is used as an enteric/delayed release coating system for drug delivery in the duodenum.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Controlled & Modified Release
Excipient Details : Ecopol L100 55 is an enteric/delayed release coating for drug delivery in the duodenum.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Application : Controlled & Modified Release
Excipient Details : Enteric, Delayed Release Matrix and Solubility Enhancement
Pharmacopoeia Ref : Multicompendial
Technical Specs : Methylacryli acid and Ethyl Acrylate copolymer (1:1) Type A
Ingredient(s) : Methacrylic Acid - Ethyl Acrylate Copolymer
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Controlled & Modified Release
Brand Name : Kollicoat MAE 100-55
Application : Controlled & Modified Release
Excipient Details : Enteric coating with release above pH 5.5 (non-neutralized powder), fast redispersing for aqueaous and organic coating
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid & Ethyl Acrylate Copolymer
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Controlled & Modified Release
Brand Name : Kollicoat MAE 100 P
Application : Controlled & Modified Release
Excipient Details : Enteric coating with release above pH 5.5 (partially preneutralized powder)
Pharmacopoeia Ref : Ph. Eur.: Methacrylic Acid
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid & Ethyl Acrylate Copolymer
Dosage Form : Capsule, Granule / Pellet, Softgel Capsule, Tablet
Grade : Not Available
Category : Controlled & Modified Release
Brand Name : Kollicoat MAE 30 DP
Application : Controlled & Modified Release
Excipient Details : Enteric coating with release above pH 5.5 (30 % solids content dispersion)
Pharmacopoeia Ref : Ph. Eur.: Methacrylic Acid
Technical Specs : Not Available
Ingredient(s) : Methacrylic Acid & Ethyl Acrylate Copolymer
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