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

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Isosorbide Mononitrate
South Africa

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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xyz-pharma-m-2024-10-07

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With Fermion, start the journey of your innovative API.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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xyz-pharma-m-2024-10-07

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Isosorbide Mononitrate

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

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, 4 Faran Shimi Pharmaceutical, 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, 6 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, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 33 Direct Compression, 32 Controlled & Modified Release, 23 Thickeners and Stabilizers, 22 Granulation, 21 Solubilizers, 21 Lubricants & Glidants, 20 Disintegrants & Superdisintegrants, 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
33 Direct Compression
32 Controlled & Modified Release
23 Thickeners and Stabilizers
22 Granulation
21 Solubilizers
21 Lubricants & Glidants
20 Disintegrants & Superdisintegrants
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

6 APIs, 1 FDF Dossiers

6 APIs
1 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP

3 EDQM
2 USP

$ API Ref.Price (USD/KG) : 94 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

Antibody Engineering

Not Confirmed

AHN Pharma (Pty) Limited

Antibody Engineering

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

02

Astrazeneca Pharmaceuticals (Pty) Ltd - ...

Antibody Engineering

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Astrazeneca Pharmaceuticals (Pty) Ltd - ...

Antibody Engineering

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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

Portfolio PDF

Product Web Link

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Corporate PDF

03

GlaxoSmithKline South Africa (Pty) Limit...

Antibody Engineering

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

GlaxoSmithKline South Africa (Pty) Limit...

Antibody Engineering

Not Confirmed

GlaxoSmithKline South Africa (Pty) Limit...

Antibody Engineering

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Pharma Dynamics (Pty) Ltd

Antibody Engineering

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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

Antibody Engineering

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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 : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Pharmaco Distribution (Pty) Ltd

Antibody Engineering

Not Confirmed

Pharmaco Distribution (Pty) Ltd

Antibody Engineering

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

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