GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23874
Submission : 2010-06-09
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17451
Submission : 2004-05-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17452
Submission : 2004-05-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33847
Submission : 2019-06-28
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35842
Submission : 2021-08-26
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34889
Submission : 2021-04-24
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36217
Submission : 2021-11-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35843
Submission : 2021-05-20
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 12243
Submission : 1996-12-06
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11819
Submission : 1996-01-17
Status : Active
Type : IV
FINISHED DOSAGE FORMULATIONS
EXCIPIENTS BY APPLICATIONS
Brand Name : Expansorb® PLGA / PEG
Application : Parenteral
Excipient Details : Expansorb® PLGA? / PEG copolymers are used as functional excipients in single dose injections for controlled and slow drug release (weeks to months).
Pharmacopoeia Ref : N/A
Technical Specs : Classic and ultrapure LMP
Ingredient(s) : Poly-DL-Lactic-co-Glycolic Acid
Brand Name : Polylactide-co-glycolide (75:25)
Application : Parenteral
Excipient Details : Poly (lactide-co-glycolide) (75:25) is used as a carrier material for sustained-release formulations including microspheres, nanocapsules & gels.
Pharmacopoeia Ref : ChP/USP
Technical Specs : Polylactide-co-glycolide (75:25); Intrinsic Viscosity: 20-30 mL/g...
Ingredient(s) : PLGA Polymers
Application : Parenteral
Excipient Details : Expansorb® PLGA copolymers are used as functional excipients for slow and controlled drug release (weeks to months) with a single injection.
Pharmacopoeia Ref : NA
Technical Specs : Classic and ultrapure LMP
Ingredient(s) : Poly-DL-Lactic-co-Glycolic Acid
Brand Name : Polylactide-co-glycolide (50:50)
Application : Parenteral
Excipient Details : Poly(lactide-co-glycolide) (50:50) is a biodegradable carrier used in parenteral dosage forms. It is also used to develop controlled release products.
Pharmacopoeia Ref : ChP/USP
Technical Specs : Polylactide-co-glycolide (50:50); Intrinsic Viscosity: 15-25 mL/g...
Ingredient(s) : PLGA Polymers
Brand Name : Expansorb® PLGA 55:45-Glu
Application : Parenteral
Excipient Details : Expansorb® PLGA 55:45-Glu is lactic acid & glycolic acid copolymer used as functional excipients in injectables for slow and controlled drug release.
Pharmacopoeia Ref : NA
Technical Specs : Classic and ultrapure LMP
Ingredient(s) : Poly-DL-Lactic-co-Glycolic Acid
Brand Name : Polylactide-co-glycolide (85:15)
Application : Parenteral
Excipient Details : Poly (lactide-co-glycolide) (85:15) is a biodegradable carrier used in parenteral controlled release dosage forms such as microspheres & nanocapsules.
Pharmacopoeia Ref : ChP/USP
Technical Specs : Polylactide-co-glycolide (85:15); Intrinsic Viscosity: 15-25 mL/g...
Ingredient(s) : PLGA Polymers
Application : Parenteral
Pharmacopoeia Ref : NA
Technical Specs : Nano-particles, ultrapure, low-monomer & powder grades, available...
Ingredient(s) : Poly DL Lactide co Glycolide
Application : Controlled & Modified Release
Excipient Details : PLGA-PEG is used in the synthesis of targeted nanoparticles which are used for differential delivery and controlled release of drugs.
Pharmacopoeia Ref : NA
Technical Specs : Nano-particles, ultrapure, low-monomer & powder grades.
Ingredient(s) : Poly-DL-Lactic-co-Glycolic Acid
Application : Controlled & Modified Release
Pharmacopoeia Ref : NA
Technical Specs : Nano-particles, ultrapure, low-monomer & powder grades, available...
Ingredient(s) : Poly DL Lactide co Glycolide
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