01

SPI Pharma

U.S.A

CPhI India

Booth #8.Q31

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

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Brand Name : Mannogem EZ

Application : Chewable & Orodispersible Aids, 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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

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

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Category : Chewable & Orodispersible Aids, Direct Compression

Brand : MANNOGEM EZ

Applications : Mannogem EZ spray-dried, is ideal for direct compression and dry blending of micronized actives in ODTs, effervescent tablets and chewable tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

02

Minakem

France

AIChE Annual Meeting

Not Confirmed

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

Dosage Form : Capsule, Tablet

Grade : Oral

Brand Name : Sodium Stearyl Fumarate GMP

Application : Lubricants & Glidants

Excipient Details : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.

Pharmacopoeia Ref : USP, EP, ICH, Q7GMP

Technical Specs : NA

Ingredient(s) : Sodium Stearyl Fumarate

Dosage Form : Capsule, Tablet

Grade : Oral

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

Ingredient(s) : Sodium Stearyl Fumarate

Dosage Form : Capsule, Tablet

Category : Lubricants & Glidants

Brand : SODIUM STEARYL FUMARATE GMP

Applications : Sodium Stearyl Fumarate is used as a lubricant in OSDs to reduce the friction and the adhesion. It also provides tablet strength & disintegration.

Pharmacopoeia Ref : USP, EP, ICH, Q7GMP

Technical Specs : NA

Grade : Oral

03

Rochem International Inc

U.S.A

AIChE Annual Meeting

Not Confirmed

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Dosage Form : Tablet

Grade : Oral

Brand Name : Mannitol

Application : Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Tablet

Grade : Oral

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Ingredient(s) : Mannitol

Dosage Form : Tablet

Category : Fillers, Diluents & Binders, Taste Masking

Brand : MANNITOL

Applications : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

04

SPI Pharma

U.S.A

CPhI India

Booth #8.Q31

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

Dosage Form : Granule / Pellet, Tablet

Grade : Oral

Brand Name : Mannogem Powder

Application : Fillers, Diluents & Binders, Granulation, Solubilizers

Excipient Details : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Granule / Pellet, Tablet

Grade : Oral

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

Ingredient(s) : Mannitol

Dosage Form : Granule / Pellet, Tablet

Category : Fillers, Diluents & Binders, Granulation, Solubilizers

Brand : MANNOGEM POWDER

Applications : Mannogem (mannitol powder) is an excellent excipient for use in wet granulation, lyophilization & improves solubility of poorly soluble APIs.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

05

SPI Pharma

U.S.A

CPhI India

Booth #8.Q31

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

Dosage Form : Tablet

Grade : Oral

Brand Name : Advantose FS95

Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Taste Masking

Excipient Details : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Fructose, Starch

Dosage Form : Tablet

Grade : Oral

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

Ingredient(s) : Fructose, Starch

Dosage Form : Tablet

Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Taste Masking

Brand : ADVANTOSE FS95

Applications : Advantose® FS95 is spray-dried fructose coprocessed with starch, is a highly compressible pharmaceutical excipient with chewable vitamin applications.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

06

SPI Pharma

U.S.A

CPhI India

Booth #8.Q31

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

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

Brand Name : Advantol 300

Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, 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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

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

Ingredient(s) : Mannitol

Dosage Form : Tablet, Orodispersible Tablet

Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Taste Masking

Brand : ADVANTOL 300

Applications : Advantol® 300 is a DC pharmaceutical excipient used to create soft chew or fast melt oral dosage forms through co-processing technology.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

07

SPI Pharma

U.S.A

CPhI India

Booth #8.Q31

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

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

Brand Name : Compressol SM

Application : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol, Sorbitol

Dosage Form : Tablet, Orodispersible Tablet

Grade : Oral

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

Ingredient(s) : Mannitol, Sorbitol

Dosage Form : Tablet, Orodispersible Tablet

Category : Chewable & Orodispersible Aids, Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand : COMPRESSOL SM

Applications : Compressol® SM, co-processed polyol, is a DC excipient of mannitol & sorbitol with superior compactibility, low disintegration time & hygroscopicity.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

08

SPI Pharma

U.S.A

CPhI India

Booth #8.Q31

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

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Brand Name : Lubripharm SSF

Application : Chewable & Orodispersible Aids, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Lubricants & Glidants

Excipient Details : Lubripharm® Sodium Stearyl Fumarate (SSF) is an inert, tablet lubricant used in orally disintegrating tablets (ODTs) and effervescent formulations.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Sodium Stearyl Fumarate

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

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

Ingredient(s) : Sodium Stearyl Fumarate

Dosage Form : Orodispersible Tablet, Tablet

Category : Chewable & Orodispersible Aids, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Lubricants & Glidants

Brand : LUBRIPHARM SSF

Applications : Lubripharm® Sodium Stearyl Fumarate (SSF) is an inert, tablet lubricant used in orally disintegrating tablets (ODTs) and effervescent formulations.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

09

SPI Pharma

U.S.A

CPhI India

Booth #8.Q31

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

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Brand Name : Mannogem Granular

Application : Chewable & Orodispersible Aids, Direct Compression, Disintegrants & Superdisintegrants

Excipient Details : Mannogem Granular has larger particles, offering a softer texture for chewable tablets and excellent flow, disintegration, and compression properties.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

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

Ingredient(s) : Mannitol

Dosage Form : Orodispersible Tablet, Tablet

Category : Chewable & Orodispersible Aids, Direct Compression, Disintegrants & Superdisintegrants

Brand : MANNOGEM GRANULAR

Applications : Mannogem Granular has larger particles, offering a softer texture for chewable tablets and excellent flow, disintegration, and compression properties.

Pharmacopoeia Ref : NA

Technical Specs : NA

Grade : Oral

10

SPI Pharma

U.S.A

CPhI India

Booth #8.Q31

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

Dosage Form : Tablet

Grade : Oral

Brand Name : ACTILLETS™

Application : Coating Systems & Additives, Controlled & Modified Release

Excipient Details : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.

Pharmacopoeia Ref : NA

Technical Specs :

Ingredient(s) : Microcrystalline Cellulose Excipients

Dosage Form : Tablet

Grade : Oral

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

Ingredient(s) : Microcrystalline Cellulose Excipients

Dosage Form : Tablet

Category : Coating Systems & Additives, Controlled & Modified Release

Brand : ACTILLETS™

Applications : ACTILLETS are microcrystalline cellulose spheres developed using advanced drug delivery technology to enable effective loading & coating of particles.

Pharmacopoeia Ref : NA

Technical Specs : Not Available

Grade : Oral

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

107 API Suppliers

41 USDMF

31 CEP/COS

17 JDMF

15 EU WC

27 KDMF

15 NDC API

45 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

10 Drugs in Development

INTERMEDIATES

18 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1014 FDF Dossiers

118 FDA Orange Book

629 Europe

63 Canada

50 Australia

34 South Africa

120 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 150MG

TABLET;ORAL - 300MG

TABLET;ORAL - 75MG

TABLET;ORAL - 12.5MG;150MG

TABLET;ORAL - 12.5MG;300MG

TABLET;ORAL - 12.5MG;75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 25MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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TABLET;ORAL - 12.5MG;75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 25MG;300MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons