Palonosetron Hydrochloride | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Palonosetron Hydrochloride
South Africa

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Jai Radhe Sales is your partner for all your sourcing needs.

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xyz-pharma-m-2024-10-07

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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

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xyz-pharma-m-2024-10-07

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Palonosetron Hydrochloride

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

INTERMEDIATES

11 Intermediates Suppliers

11 Intermediates 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- EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INTRAVENOUS - EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety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 Faran Shimi Pharmaceutical, 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 Thickeners and Stabilizers, 17 Disintegrants & Superdisintegrants, 14 Chewable & Orodispersible Aids, 14 Co-Processed Excipients, 14 Taste Masking, 11 Coating Systems & Additives, 11 Parenteral, 11 Film Formers & Plasticizers, 10 Granulation, 8 Empty Capsules, 7 Controlled & Modified Release, 3 Emulsifying Agents, 3 API Stability Enhancers, 2 Solubilizers, 2 Coloring Agents, 2 Rheology Modifiers, 1 Topical, 1 Soft Gelatin

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

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

76 US Patents, 3 Health Canada Patents

76 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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7 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 1Teva Pharmaceuticals (Pty) Ltd

filter Active Ingredients Reset all filters

7 All

01 1PALONOSETRON

02 6Palonosetron

filter Dosage Form Reset all filters

7 All

01 1Capsule

02 6INJ

filter Brand Name Reset all filters

7 All

01 1Akynzeo

02 1Kemoprev IV

03 1Onicit

04 1PALONOSETRON 0.05mg/ml FRESENIUS

05 1PALONOSETRON 0.25 TEVA

06 1Palcita

07 1Palton

List of Suppliers

Product Main Page

01

Accord Healthcare (Pty) Ltd

American Pharma Summit

Not Confirmed

Accord Healthcare (Pty) Ltd

American Pharma Summit

Not Confirmed

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Digital Content

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

American Pharma Summit

Not Confirmed

Activo Health (Pty) Ltd

American Pharma Summit

Not Confirmed

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Digital Content

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

Digital Content

Corporate PDF

03

Austell Pharmaceuticals (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

Austell Pharmaceuticals (Pty) Ltd

euroPLX 86 Munich

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Eurolab (Pty) Ltd

American Pharma Summit

Not Confirmed

Eurolab (Pty) Ltd

American Pharma Summit

Not Confirmed

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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

American Pharma Summit

Not Confirmed

Eurolab (Pty) Ltd

American Pharma Summit

Not Confirmed

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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

Digital Content

Corporate PDF

06

Fresenius Kabi South Africa (Pty) Ltd

American Pharma Summit

Not Confirmed

Fresenius Kabi South Africa (Pty) Ltd

American Pharma Summit

Not Confirmed

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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

Teva Pharmaceuticals (Pty) Ltd

American Pharma Summit

Not Confirmed

Teva Pharmaceuticals (Pty) Ltd

American Pharma Summit

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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