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

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Mesalamine
South Africa

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Mesalamine

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

93 API Suppliers, 53 USDMF, 33 CEP/COS, 13 JDMF, 14 EU WC, 10 KDMF, 45 NDC API, 43 Listed Suppliers, $ API Reference Price

93 API Suppliers
53 USDMF
33 CEP/COS
13 JDMF
14 EU WC
10 KDMF
45 NDC API
43 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

7 Intermediates Suppliers

7 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

442 FDF Dossiers, 41 FDA Orange Book, 293 Europe, 17 Canada, 40 Australia, 13 South Africa, 38 Listed Dossiers

442 FDF Dossiers
41 FDA Orange Book
293 Europe
17 Canada
40 Australia
13 South Africa
38 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- 1GM, TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, DELAYED RELEASE;ORAL - 1.2GM, CAPSULE, EXTENDED RELEASE;ORAL - 375MG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TABLET, DELAYED RELEASE;ORAL - 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

3 Evonik, 3 Rochem International Inc, 1 SPI Pharma, 2 Seqens, 11 DKSH, 1 Pharm-RX Chemical, 3 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 10 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 31 BASF, 15 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 1 Finar, 9 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 30 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 2 Lubrizol Life Science Health, 17 Microlex e.U, 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, 11 Sigachi Industries, 3 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

67 Coating Systems & Additives, 59 Fillers, Diluents & Binders, 43 Controlled & Modified Release, 37 Thickeners and Stabilizers, 31 Direct Compression, 28 Disintegrants & Superdisintegrants, 25 Solubilizers, 22 Granulation, 18 Lubricants & Glidants, 15 Topical, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 11 Taste Masking, 9 Empty Capsules, 8 Rheology Modifiers, 7 Chewable & Orodispersible Aids, 6 Parenteral, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 4 Emulsifying Agents, 1 Surfactant & Foaming Agents

67 Coating Systems & Additives
59 Fillers, Diluents & Binders
43 Controlled & Modified Release
37 Thickeners and Stabilizers
31 Direct Compression
28 Disintegrants & Superdisintegrants
25 Solubilizers
22 Granulation
18 Lubricants & Glidants
15 Topical
14 Film Formers & Plasticizers
13 Co-Processed Excipients
11 Taste Masking
9 Empty Capsules
8 Rheology Modifiers
7 Chewable & Orodispersible Aids
6 Parenteral
5 API Stability Enhancers
4 Vegetarian Capsules
4 Coloring Agents
4 Emulsifying Agents
1 Surfactant & Foaming Agents

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 66 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
66 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

9 US Medicaid Prescriptions, 200 Finished Drug Prices, 35 Annual Reports

9 US Medicaid Prescriptions
200 Finished Drug Prices
35 Annual Reports

MARKET PLACE

22 APIs, 14 FDF Dossiers

22 APIs
14 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 13 Health Canada Patents

4 US Patents
13 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 1 USP, 15 Others

4 EDQM
1 USP
15 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 47 Xls

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filter Applicant Reset all filters

13 All

01 3Cipla Medpro (Pty) Ltd

02 4Equity Pharmaceuticals (Pty) Ltd

03 5Ferring (Pty) Ltd

04 1Takeda (Pty) Ltd

filter Active Ingredients Reset all filters

13 All

01 13Mesalazine

filter Dosage Form Reset all filters

13 All

01 2ECT

02 2ENE

03 2GRA

04 3SAC

05 2SUP

06 2TAB

filter Brand Name Reset all filters

13 All

01 1Asacol 800

02 1Asacol Enema

03 1Asacol Suppositories

04 1Asacol Tablets

05 1Mezavant

06 1Pentasa 1g Enema

07 1Pentasa 1g Suppositories

08 1Pentasa 500 mg

09 1Pentasa Sachets 1 g

10 1Pentasa Sachets 2 g

11 1Salofalk 1.5 g

12 1Salofalk 1000mg

13 1Salofalk 500mg

Axplora Mesalazine

List of Suppliers

Product Main Page

01

Cipla Medpro (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Cipla Medpro (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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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

Medlab Asia & Asia Health

Not Confirmed

Cipla Medpro (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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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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Corporate PDF

03

Cipla Medpro (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Cipla Medpro (Pty) Ltd

Medlab Asia & Asia Health

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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

Medlab Asia & Asia Health

Not Confirmed

Equity Pharmaceuticals (Pty) Ltd

Medlab Asia & Asia Health

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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

Medlab Asia & Asia Health

Not Confirmed

Equity Pharmaceuticals (Pty) Ltd

Medlab Asia & Asia Health

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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

Medlab Asia & Asia Health

Not Confirmed

Equity Pharmaceuticals (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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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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Product Web Link

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Corporate PDF

07

Equity Pharmaceuticals (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Equity Pharmaceuticals (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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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

Medlab Asia & Asia Health

Not Confirmed

Ferring (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Regulatory Info : Originator

Registration Country : South Africa

Brand Name : Pentasa 1g Suppositories

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

Medlab Asia & Asia Health

Not Confirmed

Ferring (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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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

Medlab Asia & Asia Health

Not Confirmed

Ferring (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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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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