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Approved Marketing Authorisations (MA) containing Palonosetron in Europe. Original Data : EMA Website

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Product

Palonosetron
Aloxireg
Europe

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

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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-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Palonosetron

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 22 USDMF, 3 JDMF, 9 EU WC, 4 KDMF, 13 NDC API, 24 Listed Suppliers, $ API Reference Price

40 API Suppliers
22 USDMF
3 JDMF
9 EU WC
4 KDMF
13 NDC API
24 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

11 Drugs in Development

11 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

11 API Suppliers

11 API Suppliers

FINISHED DOSAGE FORMULATIONS

90 FDF Dossiers, 34 FDA Orange Book, 20 Europe, 2 Canada, 6 Australia, 7 South Africa, 21 Listed Dossiers

90 FDF Dossiers
34 FDA Orange Book
20 Europe
2 Canada
6 Australia
7 South Africa
21 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- EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not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

1 Minakem, 2 Rochem International Inc, 15 SPI Pharma, 7 DKSH, 2 Jai Radhe Sales, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 9 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 6 Actylis, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 3 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 6 Kerry, 3 Lonza Capsugel, 9 Microlex e.U, 1 NEWEDGE Overseas, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 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, 1 Ulanqab Kema New Material, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

49 Fillers, Diluents & Binders, 23 Direct Compression, 18 Lubricants & Glidants, 17 Disintegrants & Superdisintegrants, 17 Thickeners and Stabilizers, 14 Taste Masking, 14 Chewable & Orodispersible Aids, 13 Co-Processed Excipients, 12 Parenteral, 11 Film Formers & Plasticizers, 11 Coating Systems & Additives, 10 Granulation, 8 Empty Capsules, 7 Controlled & Modified Release, 3 API Stability Enhancers, 3 Emulsifying Agents, 2 Coloring Agents, 2 Rheology Modifiers, 1 Soft Gelatin, 1 Solubilizers, 1 Topical

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

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 62 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
62 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 18 Finished Drug Prices, 10 Annual Reports

1 US Medicaid Prescriptions
18 Finished Drug Prices
10 Annual Reports

MARKET PLACE

7 APIs, 6 FDF Dossiers

7 APIs
6 FDF Dossiers

PATENTS & EXCLUSIVITIES

75 US Patents, 3 Health Canada Patents

75 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

7 USP, 7 Others

7 USP
7 Others

$ API Ref.Price (USD/KG) : 680,068 Xls

Filters

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filter Applicant Reset all filters

20 All

01 1Accord Healthcare AG

02 1Accord Healthcare Ltd.

03 2HELSINN BIREX PHARMAC.LTD

04 1Helsinn Birex Pharmaceuticals Ltd

05 2Helsinn Birex Pharmaceuticals Ltd.

06 4Helsinn Birex Solvay Ltd

07 1Labatec Pharma SA

08 4Medius AG

09 1Orifarm AS

10 1Sandoz Pharmaceuticals AG

11 1Teva Pharma AG

12 1The FRESENIUS KABI NORGE AS

filter Active Ingredients Reset all filters

20 All

01 1Fosnetupitantum; Palonosetronum

02 2Netupitant, Palonosetron Hydrochloride

03 1Netupitant; Palonosetron

04 1Netupitantum; Palonosetronum

05 7Palonosetron

06 6Palonosetronum

07 2palonosetronhydroklorid

filter Dosage Form Reset all filters

20 All

01 1Caps

02 1Capsule, hard

03 2Capsule, soft

04 1Inf Conc

05 5Inj L?s

06 3Injection fluid, resolution

07 1Kaps

08 2Kapsel, hard

09 1Netupitant+Palonosetron 0,5+300Mg 1 Combined Oral Use

10 1Palonosetron 250Mcg 5Ml 1 Units Parenteral Use

11 1SOFT CAPSULE

12 1SOLUTION FOR INJECTION

filter Country Reset all filters

20 All

01 2Italy

02 8Norway

03 2Sweden

04 8Switzerland

filter Brand Name Reset all filters

20 All

01 5Akynzeo

02 1Akynzeo IV

03 8Aloxi

04 2Palonosetron Accord

05 1Palonosetron Fresenius Kabi

06 1Palonosetron Labatec

07 1Palonosetron Sandoz

08 1Palonosetron-Teva

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

Accord Healthcare Ltd.

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Accord Healthcare Ltd.

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Regulatory Info :

Registration Country : Norway

Palonosetron

Brand Name : Palonosetron Accord

Dosage Form : Injection fluid, resolution

Dosage Strength : 250 mcg

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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02

The FRESENIUS KABI NORGE AS

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The FRESENIUS KABI NORGE AS

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Regulatory Info :

Registration Country : Norway

Palonosetron

Brand Name : Palonosetron Fresenius Kabi

Dosage Form : Injection fluid, resolution

Dosage Strength : 250 mcg

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Corporate PDF

03

Helsinn Birex Pharmaceuticals Ltd.

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Helsinn Birex Pharmaceuticals Ltd.

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Regulatory Info :

Registration Country : Sweden

palonosetronhydroklorid

Brand Name : Aloxi

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 250 MICROGRAM

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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04

Helsinn Birex Pharmaceuticals Ltd.

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Helsinn Birex Pharmaceuticals Ltd.

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Regulatory Info :

Registration Country : Sweden

palonosetronhydroklorid

Brand Name : Aloxi

Dosage Form : SOFT CAPSULE

Dosage Strength : 500 MICROGRAMS

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Portfolio PDF

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05

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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06

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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07

Helsinn Birex Solvay Ltd

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Helsinn Birex Solvay Ltd

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Regulatory Info :

Registration Country : Norway

Palonosetron

Brand Name : Akynzeo

Dosage Form : Capsule, hard

Dosage Strength : 300 mg/0.5 mg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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08

Helsinn Birex Solvay Ltd

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Helsinn Birex Solvay Ltd

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Regulatory Info :

Registration Country : Norway

Palonosetron

Brand Name : Aloxi

Dosage Form : Injection fluid, resolution

Dosage Strength : 250 mcg

Packaging : Hood glass

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

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09

Helsinn Birex Solvay Ltd

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Helsinn Birex Solvay Ltd

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Regulatory Info :

Registration Country : Norway

Palonosetron

Brand Name : Aloxi

Dosage Form : Capsule, soft

Dosage Strength : 500 mcg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

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Corporate PDF

10

Helsinn Birex Solvay Ltd

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Helsinn Birex Solvay Ltd

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Regulatory Info :

Registration Country : Norway

Palonosetron

Brand Name : Aloxi

Dosage Form : Capsule, soft

Dosage Strength : 500 mcg

Packaging : Blister

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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