Palonosetron HCl | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Palonosetron HCl
Europe

Evonik

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

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pharmacompass-1-m-2026-01-12

End-to-end drug development, specializing in high-potency softgels and liquids, providing global partners with a competitive advantage.

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Palonosetron Hydrochloride

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pharmacompass-2-m-2025-11-03

Palonosetron HCl

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 21 USDMF, 4 JDMF, 8 EU WC, 4 KDMF, 11 NDC API, 22 Listed Suppliers, $ API Reference Price

40 API Suppliers
21 USDMF
4 JDMF
8 EU WC
4 KDMF
11 NDC API
22 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

26 Drugs in Development

26 Drugs in Development

INTERMEDIATES

13 Intermediate Suppliers

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

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- EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 1 Pfanstiehl, 4 Kirsch Pharma, 1 Panvo Organics, 4 ACG Worldwide, 6 Actylis, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 1 CD Formulation, 3 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures, 2 Ingredion Pharma Solutions, 2 Kerry, 2 Keval Exports, 3 Lonza Capsugel, 9 Microlex e.U, 3 Nitika Pharmaceutical Specialities, 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

48 Fillers, Diluents & Binders, 18 Disintegrants & Superdisintegrants, 18 Direct Compression, 17 Thickeners and Stabilizers, 17 Lubricants & Glidants, 16 Chewable & Orodispersible Aids, 16 Parenteral, 16 Taste Masking, 11 Co-Processed Excipients, 11 Film Formers & Plasticizers, 10 Granulation, 9 Coating Systems & Additives, 8 Empty Capsules, 5 Controlled & Modified Release, 3 Emulsifying Agents, 3 Solubilizers, 2 Coloring Agents, 2 Topical, 2 Rheology Modifiers, 2 API Stability Enhancers, 1 Soft Gelatin

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

DIGITAL CONTENT

64 News #PharmaBuzz

64 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 2 Regulatory FDF Prices, 10 Annual Reports

17 US Medicaid Prescriptions
2 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

9 APIs, 6 FDF Dossiers

9 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

36 US Patents, 3 Health Canada Patents

36 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

9 Others

9 Others

$ API Ref.Price (USD/KG) : 662,734 Xls

Filters

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24 All

01 1Accord Healthcare SLU

02 1Accord Healthcare Slu

03 1Altan Pharmaceuticals Sa

04 2Fresenius Kabi Espa?a, Sau

05 2Fresenius Kabi Norway AS

06 2HELSINN BIREX PHARMAC.LTD

07 3Helsinn Birex Pharmaceuticals Limited

08 7Helsinn Birex Pharmaceuticals Ltd

09 1Kalceks As

10 1Medochemie Limited

11 1Orifarm AS

12 1Qilu Pharma Spain Sl

13 1Reig Jofre Laboratory, Sa

filter Active Ingredients Reset all filters

24 All

01 2Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride

02 1Netupitant; Palonosetron

03 1Netupitant; Palonosetron Hydrochloride

04 2Netupitant; Palonosetron hydrochloride

05 1Palonosetron

06 9Palonosetron Hydrochloride

07 1Palonosetron Hydrochloride; Fosnetupitant

08 1Palonosetron Hydrochloride; Netupitant

09 6Palonosetronhydroklorid

filter Dosage Form Reset all filters

24 All

01 5Capsule

02 1Concentrate For Solution For Infusion

03 1Hard Capsule

04 8Injectable Solution

05 1Injectable Solution In Pre-Filled Syringe

06 1Netupitant+Palonosetron 0,5+300Mg 1 Combined Oral Use

07 1Palonosetron 250Mcg 5Ml 1 Units Parenteral Use

08 2Powder For Concentrate For Solution For Infusion

09 4Solution For Injection

filter Country Reset all filters

24 All

01 2Italy

02 8Norway

03 11Spain

04 3Sweden

filter Brand Name Reset all filters

24 All

01 8Akynzeo

02 5Aloxi

03 1Ferant

04 2Palonosetron Accord

05 1Palonosetron Altan

06 4Palonosetron Fresenius Kabi

07 1Palonosetron Kalceks

08 1Palonosetron Qilu

09 1Palonosetron Sala

List of Suppliers

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01

Altan Pharmaceuticals Sa

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Altan Pharmaceuticals Sa

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Regulatory Info : Cancelled

Registration Country : Spain

Palonosetron Hydrochloride

Brand Name : Palonosetron Altan

Dosage Form : Injectable Solution

Dosage Strength : 250MCG

Packaging :

Approval Date : 2018-07-13

Application Number : 83304

Regulatory Info : Cancelled

Registration Country : Spain

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02

Fresenius Kabi Espa?a, Sau

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Fresenius Kabi Espa?a, Sau

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Regulatory Info : Cancelled

Registration Country : Spain

Palonosetron Hydrochloride

Brand Name : Palonosetron Fresenius Kabi

Dosage Form : Injectable Solution In Pre-Filled Syringe

Dosage Strength : 250MCG

Packaging :

Approval Date : 2019-03-28

Application Number : 81901

Regulatory Info : Cancelled

Registration Country : Spain

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03

HELSINN BIREX PHARMAC.LTD

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HELSINN BIREX PHARMAC.LTD

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Regulatory Info :

Registration Country : Italy

Netupitant; Palonosetron

Brand Name : Akynzeo

Dosage Form : Netupitant+Palonosetron 0,5+300Mg 1 Combined Oral Use

Dosage Strength : 1 cps 300 mg + 0.5 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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04

HELSINN BIREX PHARMAC.LTD

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HELSINN BIREX PHARMAC.LTD

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Regulatory Info :

Registration Country : Italy

Palonosetron

Brand Name : Aloxi

Dosage Form : Palonosetron 250Mcg 5Ml 1 Units Parenteral Use

Dosage Strength : 1 ampoule EV 250 mcg 5 ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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05

Helsinn Birex Pharmaceuticals Ltd

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Helsinn Birex Pharmaceuticals Ltd

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Regulatory Info : Approved

Registration Country : Sweden

Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride

Brand Name : Akynzeo

Dosage Form : Concentrate For Solution For Infusion

Dosage Strength : 235mg/0.25mg

Packaging :

Approval Date : 12/11/2021

Application Number : 20200916000079

Regulatory Info : Approved

Registration Country : Sweden

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06

Helsinn Birex Pharmaceuticals Ltd

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Helsinn Birex Pharmaceuticals Ltd

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Regulatory Info : Approved

Registration Country : Sweden

Fosnetupitant Chloride Hydrochloride; Palonosetron Hydrochloride

Brand Name : Akynzeo

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 235mg/0.25mg

Packaging :

Approval Date : 16/03/2020

Application Number : 20181108000049

Regulatory Info : Approved

Registration Country : Sweden

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07

Helsinn Birex Pharmaceuticals Ltd

VMX

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Helsinn Birex Pharmaceuticals Ltd

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Regulatory Info : Approved

Registration Country : Sweden

Netupitant; Palonosetron Hydrochloride

Brand Name : Akynzeo

Dosage Form : Capsule

Dosage Strength : 300mg/0.5mg

Packaging :

Approval Date : 27/05/2015

Application Number : 20140125000029

Regulatory Info : Approved

Registration Country : Sweden

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08

Helsinn Birex Pharmaceuticals Limited

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Helsinn Birex Pharmaceuticals Limited

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Regulatory Info : Authorized

Registration Country : Spain

Palonosetron Hydrochloride; Fosnetupitant

Brand Name : Akynzeo

Dosage Form : Powder For Concentrate For Solution For Infusion

Dosage Strength : 235MG; 0.25 MG

Packaging :

Approval Date : 2020-06-10

Application Number : 1151001003

Regulatory Info : Authorized

Registration Country : Spain

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09

Helsinn Birex Pharmaceuticals Limited

VMX

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Helsinn Birex Pharmaceuticals Limited

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Regulatory Info : Authorized

Registration Country : Spain

Palonosetron Hydrochloride; Netupitant

Brand Name : Akynzeo

Dosage Form : Hard Capsule

Dosage Strength : 300MG; 0.5 MG

Packaging :

Approval Date : 2015-10-02

Application Number : 1151001001

Regulatory Info : Authorized

Registration Country : Spain

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10

Medochemie Limited

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Medochemie Limited

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Regulatory Info : Authorized

Registration Country : Spain

Palonosetron Hydrochloride

Brand Name : Ferant

Dosage Form : Injectable Solution

Dosage Strength : 250MCG

Packaging :

Approval Date : 2019-03-07

Application Number : 83005

Regulatory Info : Authorized

Registration Country : Spain

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Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.