SUPPLIERS
SPI Pharma has been solving formulation challenges using superior functional materials.
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Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
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 : 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 : 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 : 28402
Submission : 2014-06-18
Status :
Type : IV
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41204
Submission : 2025-01-15
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Listed Dossiers
Fillers Diluents Binders
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Mpressol (Mannitol) is a polyol used as a filler in tablet formulations, sugar-free solutions and as a bulking agent in freeze-dried products.
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, co-processed 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 used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Mannitol
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 chew or fast melt oral dosage forms through co-processing technology.
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, low 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
Application : Fillers, Diluents & Binders
Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
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.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : Mannogem® Onyx is a quick dissolving powder, with reduced sensitivity to lubricants, low friability, excellent palatability and high binding capacity.
Chewable Orodispersible Aids
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : Pharmaburst® 500 is a directly compressible, co-processed 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 : Chewable & Orodispersible Aids
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : Pharmasperse® 416 is a versatile DDS comprised of mannitol excipients and is specifically engineered for orally dispersible powder (ODP) formulations.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Brand Name : Mannogem XL Mannitol
Application : Chewable & Orodispersible Aids
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 : Orodispersible Tablet, Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : Mannogem EZ spray-dried, is ideal for direct compression and dry blending of micronized actives in ODTs, effervescent tablets and chewable tablets.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Brand Name : Mannogem Granular
Application : Chewable & Orodispersible Aids
Excipient Details : Mannogem Granular has larger particles, offering a softer texture for chewable tablets and excellent flow, disintegration, and compression properties.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Brand Name : Mannogem® XL Ruby
Application : Chewable & Orodispersible Aids
Excipient Details : Mannogem XL Ruby, granular mannitol used in pressure-sensitive, taste-masked APIs provides excellent tabletability in chewable tablets & soft-chews.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Brand Name : Mannogem® XL Opal
Application : Chewable & Orodispersible Aids
Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.
Taste Masking
Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
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 : Taste Masking
Excipient Details : Pharmaburst® 500 is a directly compressible, co-processed pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Pharmasperse® 416 is a versatile DDS comprised of mannitol excipients and is specifically engineered for orally dispersible powder (ODP) formulations.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Brand Name : Mannogem® XL Ruby
Application : Taste Masking
Excipient Details : Mannogem XL Ruby, granular mannitol used in pressure-sensitive, taste-masked APIs provides excellent tabletability in chewable tablets & soft-chews.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Brand Name : Mannogem® XL Opal
Application : Taste Masking
Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Taste Masking
Excipient Details : Mannogem® Onyx is a quick dissolving powder, with reduced sensitivity to lubricants, low friability, excellent palatability and high binding capacity.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Brand Name : Mannogem® Emerald
Application : Taste Masking
Excipient Details : Mannogem Emerald is a quick dissolving powder with high binding capacity, low friability, creamy texture & mild sweetness for excellent palatability.
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, co-processed 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 chew or fast melt oral dosage forms through co-processing technology.
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, low disintegration time & hygroscopicity.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet, Tablet
Grade : Oral
Application : Direct Compression
Excipient Details : Mannogem EZ spray-dried, is ideal for direct compression and dry blending of micronized actives in ODTs, effervescent tablets and chewable tablets.
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 has larger particles, offering a softer texture for chewable tablets and excellent flow, disintegration, and compression properties.
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.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Direct Compression
Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.
Disintegrants Superdisintegrants
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Brand Name : Mannogem XL Mannitol
Application : Disintegrants & Superdisintegrants
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 Granular
Application : Disintegrants & Superdisintegrants
Excipient Details : Mannogem Granular has larger particles, offering a softer texture for chewable tablets and excellent flow, disintegration, and compression properties.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Disintegrants & Superdisintegrants
Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.
Parenteral
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Application : Parenteral
Excipient Details : D-Mannitol protects proteins from denaturation & degradation. It is used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Mannitol
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 an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
Co Processed Excipients
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Co-Processed Excipients
Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.
Solubilizers
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Solubilizers
Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.
Thickeners And Stabilizers
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Dosage Form : Injectable / Parenteral
Grade : Parenteral, Oral
Application : Thickeners and Stabilizers
Excipient Details : D-Mannitol protects proteins from denaturation & degradation. It is used as a stabilizer in liquid products including biologic injectables & vaccines.
Pharmacopoeia Ref : USP, EP, BP, JP, ChP
Technical Specs : Low Endotoxin, Low Metals
Ingredient(s) : Mannitol
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