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 : 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
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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FINISHED DOSAGE FORMULATIONS
FDF DOSSIERS SUPPLIERS
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Fillers Diluents Binders
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
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.
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.
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
Taste Masking
Direct Compression
Disintegrants Superdisintegrants
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
Co Processed Excipients
Solubilizers
Thickeners And Stabilizers
Digital Content
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NEWS #PharmaBuzz
MARKET PLACE
FDF DOSSIERS
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EXCIPIENTS
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REF. STANDARDS & IMPURITIES
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