Ondansetron Hydrochloride | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Ondansetron Hydrochloride
Europe

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

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Ondansetron Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

61 API Suppliers, 20 USDMF, 18 CEP/COS, 6 JDMF, 7 EU WC, 14 KDMF, 24 NDC API, 30 Listed Suppliers, $ API Reference Price

61 API Suppliers
20 USDMF
18 CEP/COS
6 JDMF
7 EU WC
14 KDMF
24 NDC API
30 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

250 FDF Dossiers, 102 FDA Orange Book, 76 Europe, 39 Canada, 12 South Africa, 21 Listed Dossiers

250 FDF Dossiers
102 FDA Orange Book
76 Europe
39 Canada
12 South Africa
21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 1 Minakem, 5 Rochem International Inc, 19 SPI Pharma, 11 DKSH, 1 Pharm-RX Chemical, 9 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Shanghai Minbiotech, 2 Pfanstiehl, 7 Kirsch Pharma, 1 Panvo Organics, 4 ACG Worldwide, 13 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 7 DFE Pharma, 1 Esteem Industries, 1 Finar, 10 Gangwal Chemicals, 5 Ideal Cures, 5 Ingredion Pharma Solutions, 26 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 3 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 9 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 30 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 50 Coating Systems & Additives, 37 Direct Compression, 32 Thickeners and Stabilizers, 32 Disintegrants & Superdisintegrants, 29 Parenteral, 29 Granulation, 29 Taste Masking, 25 Controlled & Modified Release, 22 Lubricants & Glidants, 21 Chewable & Orodispersible Aids, 19 Film Formers & Plasticizers, 17 Topical, 16 Solubilizers, 13 Co-Processed Excipients, 9 Empty Capsules, 7 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules, 1 Soft Gelatin

69 Fillers, Diluents & Binders
50 Coating Systems & Additives
37 Direct Compression
32 Thickeners and Stabilizers
32 Disintegrants & Superdisintegrants
29 Parenteral
29 Granulation
29 Taste Masking
25 Controlled & Modified Release
22 Lubricants & Glidants
21 Chewable & Orodispersible Aids
19 Film Formers & Plasticizers
17 Topical
16 Solubilizers
13 Co-Processed Excipients
9 Empty Capsules
7 Emulsifying Agents
7 Rheology Modifiers
6 API Stability Enhancers
5 Surfactant & Foaming Agents
5 Coloring Agents
4 Vegetarian Capsules
1 Soft Gelatin

DIGITAL CONTENT

5 News #PharmaBuzz

5 News #PharmaBuzz

GLOBAL SALES INFORMATION

40 US Medicaid Prescriptions, 16 Regulatory FDF Prices

40 US Medicaid Prescriptions
16 Regulatory FDF Prices

MARKET PLACE

20 APIs, 2 FDF Dossiers

20 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

8 EDQM, 1 USP

8 EDQM
1 USP

$ API Ref.Price (USD/KG) : 1,549 Xls

Filters

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filter Applicant Reset all filters

76 All

01 12care4 ApS

02 2AS Kalceks

03 4Accord Healthcare BV

04 3Accord Healthcare Slu

05 1Aristo Pharma Gmbh

06 3B. Braun Melsungen Ag

07 5Bexal Farmaceutica Sa

08 7Bluefish Pharmaceuticals AB

09 1Central Procurement & Supplies Unit

10 1Cherubino Limited

11 1Eugia Pharma (Malta) Limited

12 2Farmalider Sa

13 3Fresenius Kabi Espa?a, Sau

14 2Fresenius Kabi Norway AS

15 2Hikma Farmaceutica (Portugal) Sa

16 2Ips Farma Sl

17 1Kalceks As

18 4Neuraxpharm Spain Sl

19 4Normon Laboratories Sa

20 1Novartis Ireland Limited

21 1Novartis Pharmaceuticals Sa

22 13Sandoz A/S

23 2Serra Pamies Sa Laboratories

24 4Teva Pharma Slu

25 2Viatris Limited

26 4hameln pharma GmbH

filter Active Ingredients Reset all filters

76 All

01 3Ondansetron Hydrochloride

02 40Ondansetron Hydrochloride Dihydrate

03 12Ondansetronhydroklorid

04 21Ondansetronhydrokloriddihydrat

filter Dosage Form Reset all filters

76 All

01 26Film Coated Tablet

02 1Injectable And Infusion Solution

03 2Injectable And Infusion Solution In Pre-Filled Syringe

04 1Injectable And Perfusion Solution

05 17Injectable Solution

06 2Oral Lyophilized

07 10Solution For Injection

08 1Solution For Injection And Infusion

09 6Solution For Injection/Infusion

10 4Solution For Perfusion

11 4Syrup

12 2Tablet

filter Country Reset all filters

76 All

01 3Malta

02 33Norway

03 40Spain

filter Brand Name Reset all filters

76 All

01 3Ondancetron B. Braun

02 2Ondansetron

03 5Ondansetron Accord

04 2Ondansetron Accordpharma

05 1Ondansetron Aristo

06 1Ondansetron Aurovitas

07 7Ondansetron Bluefish

08 2Ondansetron Farmalider

09 3Ondansetron Fresenius Kabi

10 4Ondansetron Hameln

11 2Ondansetron Hikma

12 2Ondansetron Ips

13 2Ondansetron Kabi

14 3Ondansetron Kalceks

15 4Ondansetron Normon

16 4Ondansetron Qualigen

17 2Ondansetron Ratio

18 2Ondansetron Serraclinics

19 2Ondansetron Teva-Ratio

20 2Ondansetron Viatris

21 19Zofran

22 2Zofran Zydis

List of Suppliers

Product Main Page

01

B. Braun Melsungen Ag

VMX

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B. Braun Melsungen Ag

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Regulatory Info : Authorized

Registration Country : Spain

Ondansetron Hydrochloride Dihydrate

Brand Name : Ondancetron B. Braun

Dosage Form : Solution For Perfusion

Dosage Strength : 0.08MG

Packaging :

Approval Date : 2017-03-06

Application Number : 81830

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

B. Braun Melsungen Ag

VMX

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B. Braun Melsungen Ag

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Digital Content

Regulatory Info : Authorized

Registration Country : Spain

Ondansetron Hydrochloride Dihydrate

Brand Name : Ondancetron B. Braun

Dosage Form : Injectable Solution

Dosage Strength : 2MG

Packaging :

Approval Date : 2008-06-19

Application Number : 69905

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Farmalider Sa

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Farmalider Sa

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Digital Content

Regulatory Info : Cancelled

Registration Country : Spain

Ondansetron Hydrochloride Dihydrate

Brand Name : Ondansetron Farmalider

Dosage Form : Injectable Solution

Dosage Strength : 4MG

Packaging :

Approval Date : 2013-05-28

Application Number : 77544

Regulatory Info : Cancelled

Registration Country : Spain

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Product Web Link

Digital Content

Corporate PDF

04

Farmalider Sa

VMX

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Farmalider Sa

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Digital Content

Regulatory Info : Cancelled

Registration Country : Spain

Ondansetron Hydrochloride Dihydrate

Brand Name : Ondansetron Farmalider

Dosage Form : Injectable Solution

Dosage Strength : 8MG

Packaging :

Approval Date : 2013-05-28

Application Number : 77545

Regulatory Info : Cancelled

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Hikma Farmaceutica (Portugal) Sa

VMX

Not Confirmed

Hikma Farmaceutica (Portugal) Sa

VMX

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Regulatory Info : Authorized

Registration Country : Spain

Ondansetron Hydrochloride Dihydrate

Brand Name : Ondansetron Hikma

Dosage Form : Injectable Solution

Dosage Strength : 8MG

Packaging :

Approval Date : 2024-09-11

Application Number : 89766

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

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06

Kalceks As

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Kalceks As

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Regulatory Info : Authorized

Registration Country : Spain

Ondansetron Hydrochloride Dihydrate

Brand Name : Ondansetron Kalceks

Dosage Form : Injectable And Perfusion Solution

Dosage Strength : 2MG

Packaging :

Approval Date : 2021-10-22

Application Number : 86340

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

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Corporate PDF

07

Normon Laboratories Sa

VMX

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Normon Laboratories Sa

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Regulatory Info : Authorized

Registration Country : Spain

Ondansetron Hydrochloride Dihydrate

Brand Name : Ondansetron Normon

Dosage Form : Injectable Solution

Dosage Strength : 8MG

Packaging :

Approval Date : 2007-11-02

Application Number : 69381

Regulatory Info : Authorized

Registration Country : Spain

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Normon Laboratories Sa

VMX

Not Confirmed

Normon Laboratories Sa

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Regulatory Info : Authorized

Registration Country : Spain

Ondansetron Hydrochloride Dihydrate

Brand Name : Ondansetron Normon

Dosage Form : Injectable Solution

Dosage Strength : 4MG

Packaging :

Approval Date : 2007-11-02

Application Number : 69380

Regulatory Info : Authorized

Registration Country : Spain

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09

Novartis Pharmaceuticals Sa

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Novartis Pharmaceuticals Sa

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Regulatory Info : Cancelled

Registration Country : Spain

Ondansetron Hydrochloride Dihydrate

Brand Name : Zofran

Dosage Form : Injectable Solution

Dosage Strength : 8MG

Packaging :

Approval Date : 1991-06-01

Application Number : 59072

Regulatory Info : Cancelled

Registration Country : Spain

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10

Ips Farma Sl

Country

VMX

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Ips Farma Sl

Country

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Regulatory Info : Cancelled

Registration Country : Spain

Ondansetron Hydrochloride Dihydrate

Brand Name : Ondansetron Ips

Dosage Form : Injectable Solution

Dosage Strength : 4MG

Packaging :

Approval Date : 2007-01-25

Application Number : 68400

Regulatory Info : Cancelled

Registration Country : Spain

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