Ondansetron, (R)-Isomer | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Ondansetron, (R)-Isomer
Europe

Minakem delivers API, HPAPI, steroids & CDMO services for generics with FDA/GMP certification, regulatory know-how & proven success.

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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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HealthTech BioActives, leading globally in Flavonoids and Vitamin B12 Derivatives.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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Aspen API. More than just an API™

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FAMAR CDMO- From early development to commercial manufacturing.

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Ondansetron, (R)-Isomer

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 20 USDMF, 18 CEP/COS, 6 JDMF, 6 EU WC, 14 KDMF, 23 NDC API, 31 Listed Suppliers, $ API Reference Price

64 API Suppliers
20 USDMF
18 CEP/COS
6 JDMF
6 EU WC
14 KDMF
23 NDC API
31 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

1 Intermediate Suppliers

1 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

212 FDF Dossiers, 102 FDA Orange Book, 40 Europe, 39 Canada, 10 South Africa, 21 Listed Dossiers

212 FDF Dossiers
102 FDA Orange Book
40 Europe
39 Canada
10 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INJECTABLE;INJECTION - EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 24MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - EQ 4MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for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, 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 Rheology Modifiers, 7 Emulsifying Agents, 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 Rheology Modifiers
7 Emulsifying Agents
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

18 APIs, 2 FDF Dossiers

18 APIs
2 FDF Dossiers

REF. STANDARDS & IMPURITIES

8 EDQM, 1 USP

8 EDQM
1 USP

$ API Ref.Price (USD/KG) : 1,181 Xls

Filters

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40 All

01 3Accord Healthcare Slu

02 1Aristo Pharma Gmbh

03 3B. Braun Melsungen Ag

04 5Bexal Farmaceutica Sa

05 1Eugia Pharma (Malta) Limited

06 2Farmalider Sa

07 3Fresenius Kabi Espa?a, Sau

08 2Hikma Farmaceutica (Portugal) Sa

09 2Ips Farma Sl

10 1Kalceks As

11 4Neuraxpharm Spain Sl

12 4Normon Laboratories Sa

13 1Novartis Pharmaceuticals Sa

14 2Serra Pamies Sa Laboratories

15 4Teva Pharma Slu

16 2Viatris Limited

filter Active Ingredients Reset all filters

40 All

01 40Ondansetron Hydrochloride Dihydrate

filter Dosage Form Reset all filters

40 All

01 13Film 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 4Solution For Perfusion

filter Country Reset all filters

40 All

01 40Spain

filter Brand Name Reset all filters

40 All

01 3Ondancetron B. Braun

02 3Ondansetron Accord

03 1Ondansetron Aristo

04 1Ondansetron Aurovitas

05 2Ondansetron Farmalider

06 1Ondansetron Fresenius Kabi

07 2Ondansetron Hikma

08 2Ondansetron Ips

09 2Ondansetron Kabi

10 1Ondansetron Kalceks

11 4Ondansetron Normon

12 4Ondansetron Qualigen

13 2Ondansetron Ratio

14 2Ondansetron Serraclinics

15 2Ondansetron Teva-Ratio

16 2Ondansetron Viatris

17 4Zofran

18 2Zofran Zydis

List of Suppliers

Product Main Page

01

B. Braun Melsungen Ag

OPRD

Not Confirmed

B. Braun Melsungen Ag

OPRD

Not Confirmed

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Digital Content

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

OPRD

Not Confirmed

B. Braun Melsungen Ag

OPRD

Not Confirmed

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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

OPRD

Not Confirmed

Farmalider Sa

OPRD

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Farmalider Sa

OPRD

Not Confirmed

Farmalider Sa

OPRD

Not Confirmed

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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

OPRD

Not Confirmed

Hikma Farmaceutica (Portugal) Sa

OPRD

Not Confirmed

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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

Product Web Link

Digital Content

Corporate PDF

06

Kalceks As

OPRD

Not Confirmed

Kalceks As

OPRD

Not Confirmed

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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

Digital Content

Corporate PDF

07

Normon Laboratories Sa

OPRD

Not Confirmed

Normon Laboratories Sa

OPRD

Not Confirmed

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Digital Content

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

OPRD

Not Confirmed

Normon Laboratories Sa

OPRD

Not Confirmed

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Digital Content

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Novartis Pharmaceuticals Sa

OPRD

Not Confirmed

Novartis Pharmaceuticals Sa

OPRD

Not Confirmed

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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

OPRD

Not Confirmed

Ips Farma Sl

Country

OPRD

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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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Website

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