Aloxi | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Aloxi
South Africa

With Fermion, start the journey of your innovative API.

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Suanfarma CDMO offers integrated end-to-end solutions for development & commercialization of intermediates & APIs for small molecules.

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Aloxi

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

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

92 FDF Dossiers, 34 FDA Orange Book, 20 Europe, 2 Canada, 4 Australia, 9 South Africa, 23 Listed Dossiers

92 FDF Dossiers
34 FDA Orange Book
20 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- EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 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, 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 Co-Processed Excipients, 17 Lubricants & Glidants, 15 Taste Masking, 14 Chewable & Orodispersible Aids, 14 Thickeners and Stabilizers, 12 Parenteral, 11 Film Formers & Plasticizers, 10 Granulation, 10 Coating Systems & Additives, 8 Empty Capsules, 6 Controlled & Modified Release, 3 Solubilizers, 3 Emulsifying Agents, 2 API Stability Enhancers, 2 Coloring Agents, 2 Topical, 2 Rheology Modifiers, 1 Soft Gelatin

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

DIGITAL CONTENT

63 News #PharmaBuzz

63 News #PharmaBuzz

GLOBAL SALES INFORMATION

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

15 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

Filters

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9 All

01 1Accord Healthcare (Pty) Ltd

02 1Activo Health (Pty) Ltd

03 1Austell Pharmaceuticals (Pty) Ltd

04 2Eurolab (Pty) Ltd

05 1Fresenius Kabi South Africa (Pty) Ltd

06 1Hetero Drugs South Africa (Pty) Ltd

07 1Macleods Pharmaceuticals SA (Pty) Ltd

08 1Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

9 All

01 1PALONOSETRON

02 8Palonosetron

filter Dosage Form Reset all filters

9 All

01 1Capsule

02 8INJ

filter Brand Name Reset all filters

9 All

01 1Akynzeo

02 1Bevativa

03 1Hetnoset

04 1Kemoprev IV

05 1Onicit

06 1PALONOSETRON 0.05mg/ml FRESENIUS

07 1PALONOSETRON 0.25 TEVA

08 1Palcita

09 1Palton

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

Pharmex

Not Confirmed

Accord Healthcare (Pty) Ltd

Pharmex

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Palonosetron

Brand Name : Palcita

Dosage Form : INJ

Dosage Strength : 0.25mg / 5ml

Packaging : 5X1mg / 5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Activo Health (Pty) Ltd

Pharmex

Not Confirmed

Activo Health (Pty) Ltd

Pharmex

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Regulatory Info : Generic

Registration Country : South Africa

Palonosetron

Brand Name : Palton

Dosage Form : INJ

Dosage Strength : 0.25mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

03

Austell Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

Austell Pharmaceuticals (Pty) Ltd

Pharmex

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Palonosetron

Brand Name : Kemoprev IV

Dosage Form : INJ

Dosage Strength : 250mcg/5ml

Packaging : 5X1mcg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Eurolab (Pty) Ltd

Pharmex

Not Confirmed

Eurolab (Pty) Ltd

Pharmex

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Palonosetron

Brand Name : Onicit

Dosage Form : INJ

Dosage Strength : 50mcg/ml

Packaging : 5X1mcg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Eurolab (Pty) Ltd

Pharmex

Not Confirmed

Eurolab (Pty) Ltd

Pharmex

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Palonosetron

Brand Name : Akynzeo

Dosage Form : Capsule

Dosage Strength : 0.5mg

Packaging : 1X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

06

Fresenius Kabi South Africa (Pty) Ltd

Pharmex

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

Pharmex

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Palonosetron

Brand Name : PALONOSETRON 0.05mg/ml FRESENIUS

Dosage Form : INJ

Dosage Strength : 0.05mg/ml

Packaging : 5X10mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Hetero Drugs South Africa (Pty) Ltd

Pharmex

Not Confirmed

Hetero Drugs South Africa (Pty) Ltd

Pharmex

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Palonosetron

Brand Name : Hetnoset

Dosage Form : INJ

Dosage Strength : 0.25mg / 5ml

Packaging : 5X1mg / 5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Macleods Pharmaceuticals SA (Pty) Ltd

Pharmex

Not Confirmed

Macleods Pharmaceuticals SA (Pty) Ltd

Pharmex

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Palonosetron

Brand Name : Bevativa

Dosage Form : INJ

Dosage Strength : 0.25mg/5ml

Packaging : 5X1mg/5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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09

Teva Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

PALONOSETRON

Brand Name : PALONOSETRON 0.25 TEVA

Dosage Form : INJ

Dosage Strength : 0.25mg / 5ml

Packaging : 5X1mg / 5ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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