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SUPPLIERS

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01

SPI Pharma

U.S.A

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

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Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

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

02

Pfanstiehl

U.S.A

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

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Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag U.S.A
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Pfanstiehl

03

SPI Pharma

U.S.A

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

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Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
SPI Pharma

04

SPI Pharma

U.S.A

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

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
SPI Pharma

05

SPI Pharma

U.S.A

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

arrow
Antibody Engineering
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
SPI Pharma

06

Shandong Tianli Pharmaceutical Co ...

China

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

Antibody Engineering
Not Confirmed
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Shandong Tianli Pharmaceutical Co ...

China

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

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Antibody Engineering
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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07

Anmol Chemicals

India

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

Antibody Engineering
Not Confirmed
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Anmol Chemicals

India

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

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Antibody Engineering
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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08

Freund Vector Corporation

U.S.A

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

Antibody Engineering
Not Confirmed
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Freund Vector Corporation

U.S.A

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

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Antibody Engineering
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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09

BASF

Germany

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

Antibody Engineering
Not Confirmed
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BASF

Germany

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

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Antibody Engineering
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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10

S D Fine Chem Limited

India

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

Antibody Engineering
Not Confirmed
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S D Fine Chem Limited

India

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

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Antibody Engineering
Not Confirmed
USDMF arrow-down CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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USDMF

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01

Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
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Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28402

Submission : 2014-06-18

Status : Active

Type : IV

SPI Pharma

02

Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 24099

Submission : 2010-08-27

Status : Active

Type : IV

SPI Pharma

03

Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 17044

Submission : 2003-12-22

Status : Active

Type : IV

SPI Pharma

04

Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Flag U.S.A
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 16037

Submission : 2002-07-03

Status : Active

Type : IV

SPI Pharma

05

Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag U.S.A
Digital Content Digital Content

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 32464

Submission : 2018-02-15

Status : Active

Type : IV

Pfanstiehl

06

Basf Se

Germany

USDMF

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Pharma, Lab & Chemical Expo
Not Confirmed

06

Basf Se

Germany
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Pharma, Lab & Chemical Expo
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 20960

Submission : 2007-10-11

Status : Active

Type : IV

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07

Freund Corp

U.S.A

USDMF

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Pharma, Lab & Chemical Expo
Not Confirmed

07

Freund Corp

U.S.A
arrow
Pharma, Lab & Chemical Expo
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 19954

Submission : 2006-10-30

Status : Active

Type : IV

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08

Roquette Freres

France

USDMF

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Pharma, Lab & Chemical Expo
Not Confirmed

09

Roquette Freres

France

USDMF

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Pharma, Lab & Chemical Expo
Not Confirmed

09

Pharma, Lab & Chemical Expo
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 14891

Submission : 2000-05-16

Status : Active

Type : IV

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CEP/COS

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Antibody Engineering
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02

Antibody Engineering
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Antibody Engineering
Not Confirmed

Certificate Number : R1-CEP 2000-039 - Rev 01

Status : Valid

Issue Date : 2019-09-12

Type : Chemical

Substance Number : 559

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03

Antibody Engineering
Not Confirmed
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FINISHED DOSAGE FORMULATIONS

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FDA Dossiers

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01

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

MANNITOL
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CPHI Middle east
Not Confirmed

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

USA
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CPHI Middle east
Not Confirmed

Route : ORAL

CAS :

UNII : 3OWL53L36A

Potency Amount : 32.58

Potency Unit : MG

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02

Dosage Form : TABLET, ORALLY DISINTEGRATING

MANNITOL
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CPHI Middle east
Not Confirmed

Dosage Form : TABLET, ORALLY DISINTEGRATING

USA
arrow
CPHI Middle east
Not Confirmed

Route : ORAL

CAS :

UNII : 3OWL53L36A

Potency Amount : 174.78

Potency Unit : MG

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03

Dosage Form : TABLET, ORALLY DISINTEGRATING

MANNITOL
arrow
CPHI Middle east
Not Confirmed

Dosage Form : TABLET, ORALLY DISINTEGRATING

USA
arrow
CPHI Middle east
Not Confirmed

Route : ORAL

CAS :

UNII : 3OWL53L36A

Potency Amount : 174.76

Potency Unit : MG

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04

Dosage Form : GUM, CHEWING

MANNITOL
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CPHI Middle east
Not Confirmed

Dosage Form : GUM, CHEWING

USA
arrow
CPHI Middle east
Not Confirmed

Route : BUCCAL

CAS : 69658

UNII : 3OWL53L36A

Potency Amount : 37.11

Potency Unit : MG

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05

Dosage Form : TABLET

MANNITOL
arrow
CPHI Middle east
Not Confirmed

Dosage Form : TABLET

USA
arrow
CPHI Middle east
Not Confirmed

Route : BUCCAL

CAS : 69658

UNII : 3OWL53L36A

Potency Amount : 97.69

Potency Unit : MG

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06

Dosage Form : TABLET

MANNITOL
arrow
CPHI Middle east
Not Confirmed

Dosage Form : TABLET

USA
arrow
CPHI Middle east
Not Confirmed

Route : BUCCAL/SUBLINGUAL

CAS : 69658

UNII : 3OWL53L36A

Potency Amount : 52.5

Potency Unit : MG

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07

Dosage Form : INJECTION

MANNITOL
arrow
CPHI Middle east
Not Confirmed

Dosage Form : INJECTION

USA
arrow
CPHI Middle east
Not Confirmed

Route : IM - IV

CAS : 69658

UNII : 3OWL53L36A

Potency Amount : 2.5

Potency Unit : %

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08

Dosage Form : POWDER, FOR INJECTION SOLUTION

MANNITOL
arrow
CPHI Middle east
Not Confirmed

Dosage Form : POWDER, FOR INJECTION SOLUTION

USA
arrow
CPHI Middle east
Not Confirmed

Route : IM - IV

CAS : 69658

UNII : 3OWL53L36A

Potency Amount : 30

Potency Unit : %

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09

Dosage Form : INJECTION

MANNITOL
arrow
CPHI Middle east
Not Confirmed

Dosage Form : INJECTION

USA
arrow
CPHI Middle east
Not Confirmed

Route : IM - IV - SC

CAS : 69658

UNII : 3OWL53L36A

Potency Amount : 0

Potency Unit : NA

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10

Dosage Form : INJECTION

MANNITOL
arrow
CPHI Middle east
Not Confirmed

Dosage Form : INJECTION

USA
arrow
CPHI Middle east
Not Confirmed

Route : IM - SC

CAS : 69658

UNII : 3OWL53L36A

Potency Amount : 0

Potency Unit : NA

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EXCIPIENTS BY APPLICATIONS

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Fillers Diluents Binders

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Chewable Orodispersible Aids

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01

SPI Pharma

U.S.A
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DDL Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Chewable & Orodispersible Aids

02

SPI Pharma

U.S.A
arrow
DDL Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Chewable & Orodispersible Aids

03

SPI Pharma

U.S.A
arrow
DDL Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Chewable & Orodispersible Aids

04

SPI Pharma

U.S.A
arrow
DDL Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Chewable & Orodispersible Aids

05

SPI Pharma

U.S.A
arrow
DDL Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Chewable & Orodispersible Aids

06

SPI Pharma

U.S.A
arrow
DDL Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Chewable & Orodispersible Aids

07

SPI Pharma

U.S.A
arrow
DDL Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Chewable & Orodispersible Aids

08

SPI Pharma

U.S.A
arrow
DDL Conference
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSPI Pharma has been solving formulation challenges using superior functional materials.

Grade : Oral

Category : Chewable & Orodispersible Aids

Taste Masking

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Direct Compression

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Parenteral

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01

Pfanstiehl

U.S.A
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Pharma, Lab & Chemical Expo
Not Confirmed
  • fda
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Virtual BoothPfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Grade : Parenteral, Oral

Category : Parenteral

03

Microlex e.U

Austria
Pharma, Lab & Chemical Expo
Not Confirmed
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Co Processed Excipients

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MARKET PLACE

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EXCIPIENTS

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A company that focuses on the manufacturing of tablets, capsules, suspensions, injectables and drops is looking for suppliers of Various Excipients for commercial purposes. The suppliers must support this enquiry with CoA. 1. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Aspartame (250 kg) Excipient 2. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Calcium Carbonate (2 MT) Granules 3. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Calcium Silicate (250 kg) Excipient 4. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade & Anhydrous Citric Acid (250 kg) Excipient 5. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Colloidal Silicone Dioxide (3 MT) Excipient 6. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Croscarmellose Sodium (2 MT) Excipient 7. USP & NF Grade Crospovidone (600 kg) Excipient 8. Ph. Eur. Grade Hypromellose (10 MT) Excipient 9. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Isopropyl Alcohol (25 MT) Excipient 10. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Lactose Monohydrate (15 MT) Excipient 11. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Magnesium Stearate (4 MT) Excipient 12. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Mannitol (10 MT) Excipient 13. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Microcrystalline Cellulose (25 MT) Excipient 14. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade PEG 4000 (25 MT) Excipient 15. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Povidone K30 & K90 (2.5 MT & 1 MT) Excipient 16. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Sodium Lauryl Sulfate (400 kg) Excipient 17. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Stearic Acid (32 MT) Excipient 18. IP/ BP/ Ph.Eur/ USP/ NF/ JP Grade Sodium Starch Glycolate (4 MT) Excipient
29 May 2023

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29 May 2023

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29 May 2023

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REF. STANDARDS & IMPURITIES

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Others

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01

USP

U.S.A
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Pharma, Lab & Chemical Expo
Not Confirmed

USP

U.S.A
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Mannitol (1.5 g)

CAS Number : 69-65-8

Quantity Per Vial : 200

Sale Unit : mg

Price : $275.00

Details : Material Origin- Plant; USMCA- No; KORUS- No

Monograph :

Storage :

Code/Batch No : Catalog #1375105 / R039T0

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