01

SPI Pharma

U.S.A

AES

Not Confirmed

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

Excipients Web Link

Virtual Booth

02

Sigachi Industries

ACECEL

AES

Not Confirmed

Not Confirmed

(3aS)-2-(3S)-1-Azabicyclo[2.2.2]oct-3-yl-2,3,3a,4,5,6-hexahydro-1H-benz[de]isoquinolin-1-one monohydrochloride

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

41 API Suppliers

21 USDMF

3 JDMF

8 EU WC

4 KDMF

11 NDC API

23 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

44 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

96 FDF Dossiers

34 FDA Orange Book

24 Europe

2 Canada

4 Australia

9 South Africa

23 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

CAPSULE;ORAL - 300MG;EQ 0.5MG BASE

SOLUTION;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

POWDER;INTRAVENOUS - EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL

SOLUTION;INTRAVENOUS - EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML)

INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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2 EUROAPI

1 Minakem

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7 DKSH

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2 Keval Exports

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3 Nitika Pharmaceutical Specialities

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4 Pluviaendo

3 Prachin Chemical

1 Qualicaps

22 Roquette

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

2 Shijiazhuang Huaxu Pharmaceutical

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3 Silverline Chemicals

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3 Vasa Pharmachem

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EXCIPIENTS BY APPLICATIONS

48 Fillers, Diluents & Binders

18 Disintegrants & Superdisintegrants

18 Direct Compression

17 Thickeners and Stabilizers

17 Lubricants & Glidants

16 Parenteral

INJECTABLE;INTRAVENOUS - EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

CAPSULE;ORAL - EQ 0.5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons