AKYNZEO COMPONENT PALONOSETRON HYDROCHLORIDE | Australian Register of Therapeutic Goods | Australia | PharmaCompass.com

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AKYNZEO COMPONENT PALONOSETRON HYDROCHLORIDE
Australia

ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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dmfs-not-supported-m-2025-06-16

AbbVie CDMO has been working with global companies to develop, manufacture & scale biopharmaceutical products.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2025-06-09

AKYNZEO COMPONENT PALONOSETRON HYDROCHLORIDE

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 22 USDMF, 3 JDMF, 8 EU WC, 4 KDMF, 12 NDC API, 23 Listed Suppliers, $ API Reference Price

44 API Suppliers
22 USDMF
3 JDMF
8 EU WC
4 KDMF
12 NDC API
23 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

13 Drugs in Development

13 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

13 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

97 FDF Dossiers, 34 FDA Orange Book, 20 Europe, 2 Canada, 10 Australia, 8 South Africa, 23 Listed Dossiers

97 FDF Dossiers
34 FDA Orange Book
20 Europe
2 Canada
10 Australia
8 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- EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety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**

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**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 2 Rochem International Inc, 16 SPI Pharma, 7 DKSH, 3 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 3 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures, 2 Ingredion Pharma Solutions, 6 Kerry, 3 Lonza Capsugel, 9 Microlex e.U, 2 Pharmatrans-Sanaq, 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, 9 Sigachi Industries, 3 Silverline Chemicals, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

47 Fillers, Diluents & Binders, 18 Disintegrants & Superdisintegrants, 18 Direct Compression, 17 Co-Processed Excipients, 16 Lubricants & Glidants, 15 Taste Masking, 14 Chewable & Orodispersible Aids, 14 Thickeners and Stabilizers, 12 Parenteral, 11 Film Formers & Plasticizers, 10 Coating Systems & Additives, 10 Granulation, 8 Empty Capsules, 6 Controlled & Modified Release, 3 Emulsifying Agents, 3 Solubilizers, 2 Rheology Modifiers, 2 API Stability Enhancers, 2 Coloring Agents, 2 Topical, 1 Soft Gelatin

47 Fillers, Diluents & Binders
18 Disintegrants & Superdisintegrants
18 Direct Compression
17 Co-Processed Excipients
16 Lubricants & Glidants
15 Taste Masking
14 Chewable & Orodispersible Aids
14 Thickeners and Stabilizers
12 Parenteral
11 Film Formers & Plasticizers
10 Coating Systems & Additives
10 Granulation
8 Empty Capsules
6 Controlled & Modified Release
3 Emulsifying Agents
3 Solubilizers
2 Rheology Modifiers
2 API Stability Enhancers
2 Coloring Agents
2 Topical
1 Soft Gelatin

DIGITAL CONTENT

63 News #PharmaBuzz

63 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 18 Regulatory FDF Prices, 10 Annual Reports

1 US Medicaid Prescriptions
18 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

8 APIs, 6 FDF Dossiers

8 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 3 Health Canada Patents

36 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

7 Others

7 Others

$ API Ref.Price (USD/KG) : 670,377 Xls

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10 All

01 2Dr Reddy's Laboratories (Australia) Pty Ltd

02 4Juniper Biologics

03 2Juniper Biologics Pty Ltd

04 2Medsurge Healthcare Pty Ltd

filter Active Ingredients Reset all filters

10 All

01 2Fosnetupitant Chloride; Palonosetron

02 2Netupitant; Palonosetron

03 6Palonosetron

filter Dosage Form Reset all filters

10 All

01 2Capsule

02 2Powder for Injection

03 6Blank

filter Brand Name Reset all filters

10 All

01 2Akynzeo

02 2Akynzeo IV

03 2Aloxi

04 2PALONOSETRON Medsurge

05 2Palonosetron Dr.Reddy's

List of Suppliers

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01

Juniper Biologics

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Juniper Biologics

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Regulatory Info :

Registration Country : Australia

Netupitant; Palonosetron

Brand Name : Akynzeo

Dosage Form : Capsule

Dosage Strength : 300MG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Juniper Biologics

World Vape Show

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Juniper Biologics

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Regulatory Info :

Registration Country : Australia

Netupitant; Palonosetron

Brand Name : Akynzeo

Dosage Form : Capsule

Dosage Strength : 300MG

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

Juniper Biologics

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Juniper Biologics

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Regulatory Info :

Registration Country : Australia

Fosnetupitant Chloride; Palonosetron

Brand Name : Akynzeo IV

Dosage Form : Powder for Injection

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Packaging : 1

Approval Date :

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Regulatory Info :

Registration Country : Australia

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04

Juniper Biologics

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Regulatory Info :

Registration Country : Australia

Fosnetupitant Chloride; Palonosetron

Brand Name : Akynzeo IV

Dosage Form : Powder for Injection

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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05

Juniper Biologics Pty Ltd

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Registration Country : Australia

Palonosetron

Brand Name : Aloxi

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Registration Country : Australia

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Juniper Biologics Pty Ltd

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Brand Name : Aloxi

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Medsurge Healthcare Pty Ltd

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Registration Country : Australia

Palonosetron

Brand Name : PALONOSETRON Medsurge

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Medsurge Healthcare Pty Ltd

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Regulatory Info :

Registration Country : Australia

Palonosetron

Brand Name : PALONOSETRON Medsurge

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Packaging : 1

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Regulatory Info :

Registration Country : Australia

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Dr Reddy's Laboratories (Australia) Pty ...

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Dr Reddy's Laboratories (Australia) Pty ...

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Dr Reddy's Laboratories (Australia) Pty ...

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Palonosetron

Brand Name : Palonosetron Dr.Reddy's

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Packaging : 1

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Regulatory Info :

Registration Country : Australia

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