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List of Drug Master Files (DMF) of Active Pharmaceutical Ingredients (APIs) submissions by Spi Pharma to the U.S. FDA. Original Data : FDA Website

SPI Pharma
USDMF

SPI Pharma-PSE

SPI Pharma & Inimmune Partner to Develop &Commercialize Vaccine Adjuvant Systems

17 Jul 2024

// PR NEWSWIRE

Embracing Patient-Centric Formulations for a Healthier Tomorrow

08 Jan 2024

// PRESS RELEASE

Offering broader access to sustainable & scalable pharma-grade saponin adjuvants

13 Oct 2023

// PRESS RELEASE

Data Compilation
#PharmaFlow

SPI Pharma RM

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CPhI Worldwide, Milan

Booth #6G33

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envelop Contact Supplier

Latest Content by PharmaCompass

SPI Pharma

VISIT THE VIRTUAL BOOTH, Contact Details

VISIT THE VIRTUAL BOOTH
Review portfolio & marketing content
CONTACT DETAILS
Google Map, LinkedIn, Emails...

EVENTS

Webinars & Exhibitions

Webinars & Exhibitions

PRESENTATION(s)

Product List 2023, Corporate Presentation, GMP Certificate 2023, Sorbitol Special®, SIM 100 DC Simethicone Powder, Pharmasperse® 416, Pharmaburst® 500, Magnesium Hydroxide Powders, Magnesium Hydroxide Pastes, Mannogem® XL Mannitol, Mannogem® Mannitol, Lubripharm® SSF Sodium Stearyl Fumarate, Effer-Soda® Sodium Bicarbonate, Directly Compressible Sugars, Compressol® SM Co Processed Polyol, CoBlend Grades Aluminum & Magnesium Hydroxide, AHMH 3535 Aluminum & Magnesium Hydroxide, Advantose® FS95 Directly Compressible Fructose, Advantose® 100 Maltose Powder, Advantol® 300, Orally Dispersible Technologies, Vaccine Adjuvants, Actimask® Taste Masked Actives, Distribution Partnership between SPI Pharma & Ingredientpharm, Pharmasolutions

Product List 2023
Corporate Presentation
GMP Certificate 2023
Sorbitol Special®
SIM 100 DC Simethicone Powder
Pharmasperse® 416
Pharmaburst® 500
Magnesium Hydroxide Powders
Magnesium Hydroxide Pastes
Mannogem® XL Mannitol
Mannogem® Mannitol
Lubripharm® SSF Sodium Stearyl Fumarate
Effer-Soda® Sodium Bicarbonate
Directly Compressible Sugars
Compressol® SM Co Processed Polyol
CoBlend Grades Aluminum & Magnesium Hydroxide
AHMH 3535 Aluminum & Magnesium Hydroxide
Advantose® FS95 Directly Compressible Fructose
Advantose® 100 Maltose Powder
Advantol® 300
Orally Dispersible Technologies
Vaccine Adjuvants
Actimask® Taste Masked Actives
Distribution Partnership between SPI Pharma & Ingredientpharm
Pharmasolutions

VIDEO(s)

Corporate Video, Solving Formulation Challenges with Superior Functional Material, Pharmasperse® ODP Platform, Effer-Soda for Effervescents, Vaccine Adjuvants, GERD Awareness Week, Introducing Mannogem® XL Opal, Mannogem® Emerald & Onyx, Mannogem® XL Ruby, MS90 for Supplement Tablets, UltraBurst™, UltraBurst™ - Flash ODT Platform, Vitasmooth® DC Calcium Carbonate, Making a Difference in Your Formulation, Pharmaburst® 500-ODT Platform, Pharmasolutions, Effer-Soda®

Corporate Video
Solving Formulation Challenges with Superior Functional Material
Pharmasperse® ODP Platform
Effer-Soda for Effervescents
Vaccine Adjuvants
GERD Awareness Week
Introducing Mannogem® XL Opal
Mannogem® Emerald & Onyx
Mannogem® XL Ruby
MS90 for Supplement Tablets
UltraBurst™
UltraBurst™ - Flash ODT Platform
Vitasmooth® DC Calcium Carbonate
Making a Difference in Your Formulation
Pharmaburst® 500-ODT Platform
Pharmasolutions
Effer-Soda®

DIGITAL CONTENT

1 VLOG #PharmaReel, 42 CORPORATE CONTENT #SupplierSpotlight, 1 DATA COMPILATION #PharmaFlow, 28 NEWS #PharmaBuzz

1 VLOG #PharmaReel
42 CORPORATE CONTENT #SupplierSpotlight
1 DATA COMPILATION #PharmaFlow
28 NEWS #PharmaBuzz

ACTIVE PHARMA INGREDIENTS

5 All APIs, 2 USDMF, 4 CEP/COS, 38 NDC API

5 All APIs
2 USDMF
4 CEP/COS
38 NDC API

EXCIPIENTS

7 All Excipients, 7 USDMF, 32 Listed Products

7 All Excipients
7 USDMF
32 Listed Products

KEY EXCIPIENTS

Pharmasperse 416, Advantol 300, Advantose 100, Advantose FS95, Compressol SM, Lubripharm SSF, Mannogem EZ Spray-Dried, Mannogem Granular, Mannogem Powder, Mannogem XL Mannitol, Pharmaburst 500, MS90, CS90, CM90, Mannogem® XL Ruby, Mannogem® XL Opal, Mannogem® Onyx, Mannogem® Emerald, DC CoDried, DC Calcium Carbonate, Vitasmooth®, DC SIM 100, AHMC 0600, AHMC 0611

Pharmasperse 416
Advantol 300
Advantose 100
Advantose FS95
Compressol SM
Lubripharm SSF
Mannogem EZ Spray-Dried
Mannogem Granular
Mannogem Powder
Mannogem XL Mannitol
Pharmaburst 500
MS90
CS90
CM90
Mannogem® XL Ruby
Mannogem® XL Opal
Mannogem® Onyx
Mannogem® Emerald
DC CoDried
DC Calcium Carbonate
Vitasmooth®
DC SIM 100
AHMC 0600
AHMC 0611

EXCIPIENTS BY INGREDIENTS

Mannitol, Aluminum Hydroxide Excipient, Magnesium Hydroxide Excipient, Calcium Carbonate Excipient, Starch, Magnesium Carbonate Excipient, Sorbitol, Tartaric Acid, Maltodextrin Excipient, Simethicone Excipient, Fructose, Sodium Stearyl Fumarate, Microcrystalline Cellulose, Sodium Bicarbonate Excipient, Maltose Sugar, Sorbitan Excipient

Mannitol
Aluminum Hydroxide Excipient
Magnesium Hydroxide Excipient
Calcium Carbonate Excipient
Starch
Magnesium Carbonate Excipient
Sorbitol
Tartaric Acid
Maltodextrin Excipient
Simethicone Excipient
Fructose
Sodium Stearyl Fumarate
Microcrystalline Cellulose
Sodium Bicarbonate Excipient
Maltose Sugar
Sorbitan Excipient

EXCIPIENTS BY APPLICATIONS

Chewable & Orodispersible Aids, Direct Compression, Taste Masking, Fillers, Diluents & Binders, Granulation, Co-Processed Excipients, API Stability Enhancers, Solubilizers, Coating Systems & Additives, Film Formers & Plasticizers, Lubricants & Glidants, Thickeners and Stabilizers

Chewable & Orodispersible Aids
Direct Compression
Taste Masking
Fillers, Diluents & Binders
Granulation
Co-Processed Excipients
API Stability Enhancers
Solubilizers
Coating Systems & Additives
Film Formers & Plasticizers
Lubricants & Glidants
Thickeners and Stabilizers

INSPECTIONS & REGISTRATIONS

12 FDA, 17 EDQM, 3 GDUFA

12 FDA
17 EDQM
3 GDUFA

Xls

Filters

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FILTER :

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2 All

01 1CALCIUM CARBONATE, MAG. HYDROXIDE GRAN

02 1MAGNESIUM HYDROXIDE USP BARCROFT™ 5100 CG POWDER

filter Holder Reset all filters

2 All

01 2SPI PHARMA INC

filter Country Reset all filters

2 All

01 2U.S.A

filter Status Reset all filters

2 All

01 2Active

filter GDUFA DMF Review Reset all filters

2 All

01 2Blank

APIs
USDMF
CEP/COS
NDC API

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01

Magnesium Hydroxide Usp Barcroft™ ...

CPhI Worldwide, Milan

SPI Pharma has been solving formulation challenges using superior functional materials.

Contact Supplier

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Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39418

Submission : 2024-03-06

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

02

Calcium Carbonate, Mag. Hydroxide Gr...

CPhI Worldwide, Milan

SPI Pharma has been solving formulation challenges using superior functional materials.

Contact Supplier

Contact Supplier

Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 39027

Submission : 2024-06-14

Status : Active

Type : II

Product
Web Link

Stock Recap
#PipelineProspector

Contact Spi Pharma and get a quotation

Spi Pharma is a supplier offers 4 products (APIs, Excipients or Intermediates).

Find a price of Magnesium Hydroxide bulk with DMF, CEP offered by Spi Pharma

Find a price of Aluminum bulk with CEP offered by Spi Pharma

Find a price of Magnesium Hydroxide bulk with CEP offered by Spi Pharma

Find a price of CALCIUM CARBONATE, MAG. HYDROXIDE GRAN bulk with DMF offered by Spi Pharma

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