Mannitol | Pharma Excipients | News | Suppliers

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CHEMISTRY

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INACTIVE PHARMA INGREDIENTS

20 Suppliers, 17 USDMF, 3 CEP/COS, 3 NDC API, 37 Listed Suppliers

20 Suppliers
17 USDMF
3 CEP/COS
3 NDC API
37 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

751 FDF Dossiers Suppliers, 114 FDA Listed Dossiers

751 FDF Dossiers Suppliers
114 FDA Listed Dossiers

EXCIPIENTS BY APPLICATIONS

24 Fillers, Diluents & Binders, 11 Chewable & Orodispersible Aids, 10 Taste Masking, 10 Direct Compression, 7 Disintegrants & Superdisintegrants, 5 Co-Processed Excipients, 5 Parenteral, 3 Granulation, 1 Solubilizers, 1 Thickeners and Stabilizers

24 Fillers, Diluents & Binders
11 Chewable & Orodispersible Aids
10 Taste Masking
10 Direct Compression
7 Disintegrants & Superdisintegrants
5 Co-Processed Excipients
5 Parenteral
3 Granulation
1 Solubilizers
1 Thickeners and Stabilizers

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 4 NEWS #PharmaBuzz

3 DATA COMPILATION #PharmaFlow
4 NEWS #PharmaBuzz

MARKET PLACE

3 APIs, 1 DOSSIERS, 32 EXCIPIENTS

3 APIs
1 DOSSIERS
32 EXCIPIENTS

REF. STANDARDS & IMPURITIES

1 Others

1 Others

Chemistry

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Click the button for full data set

SUPPLIERS

01

SPI Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI North America

Attending

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

Contact Supplier

U.S.A

Virtual Booth

Digital Content

USDMF

Click Us!

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Pfanstiehl

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BPI Europe

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

03

SPI Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI North America

Attending

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

Contact Supplier

U.S.A

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

04

SPI Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI North America

Attending

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

Contact Supplier

U.S.A

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

05

SPI Pharma

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

CPhI North America

Attending

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

Contact Supplier

U.S.A

Virtual Booth

Digital Content

USDMF

CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

06

Roquette

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BPI Europe

Not Confirmed

07

Westpoint pharma

China

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

BPI Europe

Not Confirmed

Only 10 entries up to this point, click to access all

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USDMF

01

Spi Pharma Inc

U.S.A

CPhI North America

Attending

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

Contact Supplier

U.S.A

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Digital Content

PHARMABURST(TM) C1

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17044

Submission : 2003-12-22

Status : Active

Type : IV

02

Spi Pharma Inc

U.S.A

CPhI North America

Attending

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

Contact Supplier

U.S.A

Virtual Booth

Digital Content

PHARMABURST® B SERIES PRODUCTS

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16037

Submission : 2002-07-03

Status : Active

Type : IV

03

Spi Pharma Inc

U.S.A

CPhI North America

Attending

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

Contact Supplier

U.S.A

Virtual Booth

Digital Content

PHARMABURST® 530

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28402

Submission : 2014-06-18

Status : Active

Type : IV

04

Spi Pharma Inc

U.S.A

CPhI North America

Attending

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

Contact Supplier

U.S.A

Virtual Booth

Digital Content

PHARMABURST® 500 AND SL SERIES

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24099

Submission : 2010-08-27

Status : Active

Type : IV

05

Pfanstiehl Inc

U.S.A

BPI Europe

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

D-MANNITOL (PLANT DERIVED) HIGH PURITY...

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32464

Submission : 2018-02-15

Status : Active

Type : IV

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

06

Basf Se

Germany

BPI Europe

Not Confirmed

07

Freund Corp

U.S.A

BPI Europe

Not Confirmed

08

Roquette Freres

France

BPI Europe

Not Confirmed

09

Roquette Freres

France

BPI Europe

Not Confirmed

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CEP/COS

01

CARGILL S.R.L. DIVISIONE AMIDI DERI...

U.S.A

BPI Europe

Not Confirmed

02

Roquette Frères Lestrem FR

France

BPI Europe

Not Confirmed

03

Roquette Frères Lestrem FR

France

France

BPI Europe

Not Confirmed

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FINISHED DOSAGE FORMULATIONS

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FDF DOSSIERS SUPPLIERS

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FDA Listed Dossiers

01

Dosage Form : TABLET (IMMED./COMP. RELEASE),...

MANNITOL

Bioequity Europe

Not Confirmed

Not Confirmed

Only 10 entries up to this point, click to access all

EXCIPIENTS BY APPLICATIONS

Click here to find the perfect excipient manufacturers by their capabilities

Fillers Diluents Binders

01

Rochem International Inc

U.S.A

CPhI WW Frankfurt

Booth #12.0F117

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

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Mannitol

Application : Fillers, Diluents & Binders

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

02

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Pharmaburst 500

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

03

Gangwal Healthcare

India

CPhI South East Asia

Attending

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Mpressol™

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.

Pharmacopoeia Ref : USP-NF, BP, IP, EP, DMF, EXCiP...

Technical Specs : NA

Ingredient(s) : Mannitol

04

Pfanstiehl

U.S.A

BioProcess International Europe

Not Confirmed

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

Category : Fillers, Diluents & Binders

Brand Name : D-Mannitol

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.

Pharmacopoeia Ref : USP, NF, EP, JP, ChP

Technical Specs : N/A

Ingredient(s) : Mannitol

05

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Advantol 300

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

06

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Compressol SM

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

07

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

08

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Mannogem Powder

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

09

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

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.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Ingredient(s) : Mannitol

10

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Mannogem® Onyx

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.

Pharmacopoeia Ref : NA

Technical Specs : 50 µm Powder

Ingredient(s) : Mannitol

Only 10 entries up to this point, click to access all

Chewable Orodispersible Aids

Taste Masking

01

Rochem International Inc

U.S.A

CPhI WW Frankfurt

Booth #12.0F117

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

Dosage Form : Tablet

Grade : Oral

Category : Taste Masking

Brand Name : Mannitol

Application : 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

02

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Taste Masking

Brand Name : Pharmaburst 500

Application : Taste Masking

Excipient Details : Pharmaburst® 500 is a directly compressible, co-processed pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

03

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Taste Masking

Brand Name : Advantol 300

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

04

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Taste Masking

Brand Name : Pharmasperse 416

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

05

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Taste Masking

Brand Name : Compressol SM

Application : 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

06

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Taste Masking

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.

Pharmacopoeia Ref : NA

Technical Specs : 300 µm Granular Mannitol

Ingredient(s) : Mannitol

07

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Taste Masking

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.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Ingredient(s) : Mannitol

08

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Taste Masking

Brand Name : Mannogem® Onyx

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.

Pharmacopoeia Ref : NA

Technical Specs : 50 µm Powder

Ingredient(s) : Mannitol

09

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Taste Masking

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.

Pharmacopoeia Ref : NA

Technical Specs : 25 µm Powder Mannitol

Ingredient(s) : Mannitol

10

Gangwal Chemicals

India

BPI Europe

Not Confirmed

Direct Compression

01

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Orodispersible Tablet

Grade : Oral

Category : Direct Compression

Brand Name : Pharmaburst 500

Application : Direct Compression

Excipient Details : Pharmaburst® 500 is a directly compressible, co-processed pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

02

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Direct Compression

Brand Name : Advantol 300

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

03

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Direct Compression

Brand Name : Compressol SM

Application : Direct Compression

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

04

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Direct Compression

Brand Name : Mannogem EZ

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

05

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Direct Compression

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

06

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Direct Compression

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.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Ingredient(s) : Mannitol

07

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Direct Compression

Brand Name : Mannogem 2080

Application : Direct Compression

Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.

Pharmacopoeia Ref : NA

Technical Specs : Not Available

Ingredient(s) : Mannitol

08

Sigachi Industries

India

BioProcess International Europe

Not Confirmed

09

Microlex e.U

Austria

BioProcess International Europe

Not Confirmed

10

BASF

Germany

BioProcess International Europe

Not Confirmed

Disintegrants Superdisintegrants

01

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Disintegrants & Superdisintegrants

Brand Name : Advantol 300

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

02

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Orodispersible Tablet

Grade : Oral

Category : Disintegrants & Superdisintegrants

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

03

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Disintegrants & Superdisintegrants

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.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

04

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Tablet

Grade : Oral

Category : Disintegrants & Superdisintegrants

Brand Name : Mannogem 2080

Application : Disintegrants & Superdisintegrants

Excipient Details : Mannogem 2080 exhibits excellent flow, disintegration and compression properties.

Pharmacopoeia Ref : NA

Technical Specs : Not Available

Ingredient(s) : Mannitol

05

Sigachi Industries

India

BioProcess International Europe

Not Confirmed

06

Gangwal Chemicals

India

BioProcess International Europe

Not Confirmed

07

Gangwal Chemicals

India

BioProcess International Europe

Not Confirmed

Co Processed Excipients

Parenteral

01

Pfanstiehl

U.S.A

BPI Europe

Not Confirmed

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

Category : Parenteral

Brand Name : D-Mannitol

Application : Parenteral

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.

Pharmacopoeia Ref : USP, NF, EP, JP, ChP

Technical Specs : N/A

Ingredient(s) : Mannitol

Excipients Web Link

SPI Pharma

U.S.A

CPhI North America

Attending

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

Dosage Form : Granule / Pellet, Tablet

Grade : Oral

Category : Granulation

Brand Name : Mannogem Powder

Application : Granulation

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

02

Microlex e.U

Austria

BioProcess International Europe

Not Confirmed

03

BASF

Germany

BioProcess International Europe

Not Confirmed

Solubilizers

Thickeners And Stabilizers

Digital Content

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DATA COMPILATION #PharmaFlow

Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination

The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards. Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio. Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients. The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience. View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.