Isosorbide Mononitrate | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Isosorbide Mononitrate
South Africa

Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.

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

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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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Isosorbide Mononitrate

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ACTIVE PHARMA INGREDIENTS

29 API Suppliers, 12 USDMF, 10 CEP/COS, 4 JDMF, 2 EU WC, 5 KDMF, 5 NDC API, 11 Listed Suppliers, $ API Reference Price

29 API Suppliers
12 USDMF
10 CEP/COS
4 JDMF
2 EU WC
5 KDMF
5 NDC API
11 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

218 FDF Dossiers, 49 FDA Orange Book, 114 Europe, 5 Canada, 12 Australia, 7 South Africa, 31 Listed Dossiers

218 FDF Dossiers
49 FDA Orange Book
114 Europe
5 Canada
12 Australia
7 South Africa
31 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 20MG

TABLET;ORAL - 10MG
TABLET;ORAL - 20MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 1 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 12 Corel Pharma Chem, 6 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 34 Direct Compression, 32 Controlled & Modified Release, 23 Thickeners and Stabilizers, 22 Granulation, 22 Solubilizers, 21 Disintegrants & Superdisintegrants, 21 Lubricants & Glidants, 17 Co-Processed Excipients, 13 Film Formers & Plasticizers, 11 Parenteral, 10 Taste Masking, 10 Topical, 9 Emulsifying Agents, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

68 Fillers, Diluents & Binders
46 Coating Systems & Additives
34 Direct Compression
32 Controlled & Modified Release
23 Thickeners and Stabilizers
22 Granulation
22 Solubilizers
21 Disintegrants & Superdisintegrants
21 Lubricants & Glidants
17 Co-Processed Excipients
13 Film Formers & Plasticizers
11 Parenteral
10 Taste Masking
10 Topical
9 Emulsifying Agents
6 Chewable & Orodispersible Aids
5 Empty Capsules
5 API Stability Enhancers
4 Vegetarian Capsules
4 Coloring Agents
3 Rheology Modifiers
2 Surfactant & Foaming Agents

DIGITAL CONTENT

6 NEWS #PharmaBuzz

6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 98 Finished Drug Prices

1 US Medicaid Prescriptions
98 Finished Drug Prices

MARKET PLACE

5 APIs, 1 FDF Dossiers

5 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP

3 EDQM
2 USP

$ API Ref.Price (USD/KG) : 92 Xls

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7 All

01 1AHN Pharma (Pty) Limited

02 1Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

03 2GlaxoSmithKline South Africa (Pty) Limited

04 1Pharma Dynamics (Pty) Ltd

05 2Pharmaco Distribution (Pty) Ltd

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7 All

01 1Isosorbide Mononitrate

02 3Isosorbide mononitrate

03 3Isosorbide-5-Mononitrate

filter Dosage Form Reset all filters

7 All

01 1SRC

02 1SRT

03 5TAB

filter Brand Name Reset all filters

7 All

01 2Elantan 20

02 1Elantan LA

03 2ISMO 20

04 1Imdur 60 mg

05 1Monicor Sr 60

List of Suppliers

Product Main Page

01

AHN Pharma (Pty) Limited

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AHN Pharma (Pty) Limited

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Isosorbide mononitrate

Brand Name : Elantan LA

Dosage Form : SRC

Dosage Strength : 50mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Astrazeneca Pharmaceuticals (Pty) Ltd - ...

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Isosorbide Mononitrate

Brand Name : Imdur 60 mg

Dosage Form : SRT

Dosage Strength : 60mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

GlaxoSmithKline South Africa (Pty) Limit...

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GlaxoSmithKline South Africa (Pty) Limit...

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Isosorbide mononitrate

Brand Name : Elantan 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

GlaxoSmithKline South Africa (Pty) Limit...

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GlaxoSmithKline South Africa (Pty) Limit...

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Isosorbide mononitrate

Brand Name : Elantan 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 500X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Corporate PDF

05

Pharma Dynamics (Pty) Ltd

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Pharma Dynamics (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Isosorbide-5-Mononitrate

Brand Name : Monicor Sr 60

Dosage Form : TAB

Dosage Strength : 60mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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06

Pharmaco Distribution (Pty) Ltd

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Pharmaco Distribution (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Isosorbide-5-Mononitrate

Brand Name : ISMO 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Product Web Link

Digital Content

Corporate PDF

07

Pharmaco Distribution (Pty) Ltd

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Pharmaco Distribution (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Isosorbide-5-Mononitrate

Brand Name : ISMO 20

Dosage Form : TAB

Dosage Strength : 20mg

Packaging : 500X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Digital Content

Corporate PDF

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