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SPI Pharma has been solving formulation challenges using superior functional materials.
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Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
SPI Pharma has been solving formulation challenges using superior functional materials.
SPI Pharma has been solving formulation challenges using superior functional materials.
SPI Pharma has been solving formulation challenges using superior functional materials.
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USDMF
SPI Pharma has been solving formulation challenges using superior functional materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24099
Submission : 2010-08-27
Status :
Type : IV
SPI Pharma has been solving formulation challenges using superior functional materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17044
Submission : 2003-12-22
Status :
Type : IV
SPI Pharma has been solving formulation challenges using superior functional materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16037
Submission : 2002-07-03
Status :
Type : IV
SPI Pharma has been solving formulation challenges using superior functional materials.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28402
Submission : 2014-06-18
Status :
Type : IV
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32464
Submission : 2018-02-15
Status :
Type : IV
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]LISTED SUPPLIERS
FINISHED DOSAGE FORMULATIONS
FDF DOSSIERS SUPPLIERS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Drug : MYOZYME
Dosage Form : INJECTABLE; IV (INFUSION)
Application Number : 125141
Country : US
Patented : No
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Drug : PLAVIX
Dosage Form : TABLET; ORAL
Application Number : 20839
Country : US
Patented : No
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE
Drug : LUPANETA PACK
Dosage Form : INJECTABLE, TABLET; INTRAMUSCULAR, ORAL
Application Number : 203696
Country : US
Patented : No
Drug : DALVANCE
Dosage Form : POWDER; INTRAVENOUS
Application Number : 21883
Country : US
Patented : Yes
Drug : SAPHRIS
Dosage Form : TABLET; SUBLINGUAL
Application Number : 22117
Country : US
Patented : Yes
Drug : DILACOR XR
Dosage Form : CAPSULE, EXTENDED RELEASE; ORAL
Application Number : 20092
Country : US
Patented : No
CARBIDOPA; ENTACAPONE; LEVODOPA
Drug : STALEVO 75
Dosage Form : TABLET; ORAL
Application Number : 21485
Country : US
Patented : No
CARBIDOPA; ENTACAPONE; LEVODOPA
Drug : STALEVO 200
Dosage Form : TABLET; ORAL
Application Number : 21485
Country : US
Patented : No
CARBIDOPA; ENTACAPONE; LEVODOPA
Drug : STALEVO 150
Dosage Form : TABLET; ORAL
Application Number : 21485
Country : US
Patented : No
CARBIDOPA; ENTACAPONE; LEVODOPA
Drug : STALEVO 100
Dosage Form : TABLET; ORAL
Application Number : 21485
Country : US
Patented : No
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Listed Dossiers
Fillers Diluents Binders
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Tablet
Grade : Parenteral, Oral
Application : Fillers, Diluents & Binders
Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chewable or soft melt oral dosage forms & enables rapid product development.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, lower disintegration time & hygroscopicity
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Brand Name : Mannogem XL Mannitol
Application : Fillers, Diluents & Binders
Excipient Details : Mannogem® XL is a DC spray-dried mannitol used to enhance mannitol formulation tabletability & provide superior binding & quick disintegration.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Brand Name : Mannogem EZ Spray-Dried
Application : Fillers, Diluents & Binders
Excipient Details : Mannogem EZ Spray-Dried, a mannitol product, dissolves rapidly and can increase the rate of tablet disintegration, drug dissolution & drug release.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Brand Name : Mannogem Granular
Application : Fillers, Diluents & Binders
Excipient Details : Mannogem Granular (mannitol) dissolves rapidly and can increase the rate of tablet disintegration, subsequent drug dissolution and drug release.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Mannogem (mannitol powder) is a pharmaceutical excipient that dissolves rapidly and increases tablet disintegration rate, drug dissolution & release.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Brand Name : Mannogem® XL Opal
Application : Fillers, Diluents & Binders
Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.
Chewable Orodispersible Aids
Taste Masking
Direct Compression
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Direct Compression
Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Direct Compression
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chewable or soft melt oral dosage forms & enables rapid product development.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Direct Compression
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, lower disintegration time & hygroscopicity
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Brand Name : Mannogem EZ Spray-Dried
Application : Direct Compression
Excipient Details : Mannogem EZ Spray-Dried, a mannitol product, dissolves rapidly and can increase the rate of tablet disintegration, drug dissolution & drug release.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Brand Name : Mannogem Granular
Application : Direct Compression
Excipient Details : Mannogem Granular (mannitol) dissolves rapidly and can increase the rate of tablet disintegration, subsequent drug dissolution and drug release.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Brand Name : Mannogem® XL Opal
Application : Direct Compression
Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.
Parenteral
Co Processed Excipients
Granulation
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Granule / Pellet, Tablet
Grade : Oral
Application : Granulation
Excipient Details : Mannogem (mannitol powder) is a pharmaceutical excipient that dissolves rapidly and increases tablet disintegration rate, drug dissolution & release.
Disintegrants Superdisintegrants
API Stability Enhancers
Thickeners And Stabilizers
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