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

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Mesalamine
South Africa

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Zhejiang Hengkang Mesalazine

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Mesalamine

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

113 API Suppliers, 53 USDMF, 35 CEP/COS, 13 JDMF, 17 EU WC, 10 KDMF, 38 NDC API, 47 Listed Suppliers, $ API Reference Price

113 API Suppliers
53 USDMF
35 CEP/COS
13 JDMF
17 EU WC
10 KDMF
38 NDC API
47 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

55 Drugs in Development

55 Drugs in Development

INTERMEDIATES

7 Intermediate Suppliers

7 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

576 FDF Dossiers, 45 FDA Orange Book, 398 Europe, 18 Canada, 46 Australia, 17 South Africa, 52 Listed Dossiers

576 FDF Dossiers
45 FDA Orange Book
398 Europe
18 Canada
46 Australia
17 South Africa
52 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

ENEMA;RECTAL - 4GM/60ML, CAPSULE, EXTENDED RELEASE;ORAL - 250MG, CAPSULE, EXTENDED RELEASE;ORAL - 500MG, CAPSULE, DELAYED RELEASE;ORAL - 400MG, SUPPOSITORY;RECTAL - 1GM, TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 1.2GM, CAPSULE, EXTENDED RELEASE;ORAL - 375MG

ENEMA;RECTAL - 4GM/60ML
CAPSULE, EXTENDED RELEASE;ORAL - 250MG
CAPSULE, EXTENDED RELEASE;ORAL - 500MG
CAPSULE, DELAYED RELEASE;ORAL - 400MG
SUPPOSITORY;RECTAL - 1GM
TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET, DELAYED RELEASE;ORAL - 1.2GM
CAPSULE, EXTENDED RELEASE;ORAL - 375MG

RELATED EXCIPIENT COMPANIES

8 Evonik, 3 Rochem International Inc, 1 SPI Pharma, 14 DKSH, 1 Pharm-RX Chemical, 5 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Kirsch Pharma, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 3 Ashland, 31 BASF, 1 CD Formulation, 15 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 1 Esteem Industries, 1 Finar, 9 Gangwal Chemicals, 12 Ideal Cures, 1 Ingredion Pharma Solutions, 20 Kerry, 3 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 17 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 3 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 13 Roquette, 6 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

65 Coating Systems & Additives, 47 Fillers, Diluents & Binders, 42 Thickeners and Stabilizers, 39 Controlled & Modified Release, 28 Disintegrants & Superdisintegrants, 28 Solubilizers, 25 Granulation, 23 Direct Compression, 17 Lubricants & Glidants, 16 Topical, 14 Film Formers & Plasticizers, 12 Rheology Modifiers, 11 Taste Masking, 9 Chewable & Orodispersible Aids, 9 Empty Capsules, 8 Co-Processed Excipients, 5 Emulsifying Agents, 5 Parenteral, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Surfactant & Foaming Agents

65 Coating Systems & Additives
47 Fillers, Diluents & Binders
42 Thickeners and Stabilizers
39 Controlled & Modified Release
28 Disintegrants & Superdisintegrants
28 Solubilizers
25 Granulation
23 Direct Compression
17 Lubricants & Glidants
16 Topical
14 Film Formers & Plasticizers
12 Rheology Modifiers
11 Taste Masking
9 Chewable & Orodispersible Aids
9 Empty Capsules
8 Co-Processed Excipients
5 Emulsifying Agents
5 Parenteral
5 API Stability Enhancers
4 Vegetarian Capsules
4 Coloring Agents
1 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 71 News #PharmaBuzz

1 Data Compilation #PharmaFlow
71 News #PharmaBuzz

GLOBAL SALES INFORMATION

41 US Medicaid Prescriptions, 155 Regulatory FDF Prices, 37 Annual Reports

41 US Medicaid Prescriptions
155 Regulatory FDF Prices
37 Annual Reports

MARKET PLACE

24 APIs, 14 FDF Dossiers

24 APIs
14 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 10 Health Canada Patents

4 US Patents
10 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 22 Others

4 EDQM
22 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 45 Xls

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17 All

01 3Cipla Medpro (Pty) Ltd

02 4Equity Pharmaceuticals (Pty) Ltd

03 5Ferring (Pty) Ltd

04 1Ranbaxy Pharmaceuticals (Pty) Ltd

05 1Takeda (Pty) Ltd

06 3Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

17 All

01 1MESALAZINE

02 16Mesalazine

filter Dosage Form Reset all filters

17 All

01 3ECT

02 2ENE

03 2GRA

04 3SAC

05 3SRT

06 2SUP

07 2TAB

filter Brand Name Reset all filters

17 All

01 1Asacol 800

02 1Asacol Enema

03 1Asacol Suppositories

04 1Asacol Tablets

05 1COLIZEM

06 1Mezavant

07 1Pentasa 1g

08 1Pentasa 1g Enema

09 1Pentasa 500 mg

10 1Pentasa Sachets 1 g

11 1Pentasa Sachets 2 g

12 1Salofalk 1.5 g

13 1Salofalk 1000mg

14 1Salofalk 500mg

15 1Zylamene SR 1 200

16 2Zylamene SR 800

Axplora Mesalazine

List of Suppliers

Product Main Page

01

Cipla Medpro (Pty) Ltd

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Cipla Medpro (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Salofalk 1.5 g

Dosage Form : SAC

Dosage Strength : 1.5g

Packaging : 100X1g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Cipla Medpro (Pty) Ltd

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Cipla Medpro (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Salofalk 500mg

Dosage Form : GRA

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Cipla Medpro (Pty) Ltd

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Cipla Medpro (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Salofalk 1000mg

Dosage Form : GRA

Dosage Strength : 1000mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Equity Pharmaceuticals (Pty) Ltd

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Equity Pharmaceuticals (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Asacol 800

Dosage Form : ECT

Dosage Strength : 800mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Equity Pharmaceuticals (Pty) Ltd

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Equity Pharmaceuticals (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Asacol Tablets

Dosage Form : ECT

Dosage Strength : 400mg

Packaging : 90X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Equity Pharmaceuticals (Pty) Ltd

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Equity Pharmaceuticals (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Asacol Enema

Dosage Form : ENE

Dosage Strength : 2g/ml

Packaging : 50X1g/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

Equity Pharmaceuticals (Pty) Ltd

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Equity Pharmaceuticals (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Asacol Suppositories

Dosage Form : SUP

Dosage Strength : 500mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Ferring (Pty) Ltd

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Ferring (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Pentasa 1g

Dosage Form : SUP

Dosage Strength : 1g

Packaging : 28X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Ferring (Pty) Ltd

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Ferring (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Pentasa 1g Enema

Dosage Form : ENE

Dosage Strength : 1g/100ml

Packaging : 100X7g/100ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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10

Ferring (Pty) Ltd

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Ferring (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Pentasa Sachets 1 g

Dosage Form : SAC

Dosage Strength : 1g

Packaging : 120X1g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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