Polymyxin B Sulfate | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Polymyxin B Sulfate
South Africa

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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

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Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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xyz-pharma-m-2025-01-06

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Polymyxin B Sulfate

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 13 USDMF, 6 CEP/COS, 2 JDMF, 1 EU WC, 2 KDMF, 20 NDC API, 21 Listed Suppliers, $ API Reference Price

32 API Suppliers
13 USDMF
6 CEP/COS
2 JDMF
1 EU WC
2 KDMF
20 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

144 FDF Dossiers, 95 FDA Orange Book, 7 Europe, 19 Canada, 7 South Africa, 16 Listed Dossiers

144 FDF Dossiers
95 FDA Orange Book
7 Europe
19 Canada
7 South Africa
16 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM, OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, OINTMENT;OPHTHALMIC - EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM, SOLUTION/DROPS;OPHTHALMIC - 10,000 UNITS/ML;EQ 1MG BASE/ML

OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
OINTMENT;OPHTHALMIC - EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM
SOLUTION/DROPS;OPHTHALMIC - 10,000 UNITS/ML;EQ 1MG BASE/ML

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 Seqens, 2 DKSH, 1 Gangwal Healthcare, 8 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 17 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 24 BASF, 10 Corel Pharma Chem, 3 Finar, 9 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 19 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 4 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 1 Pluviaendo, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 5 Roquette, 17 Seppic, 1 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

44 Coating Systems & Additives, 36 Topical, 33 Solubilizers, 22 Parenteral, 21 Controlled & Modified Release, 19 Thickeners and Stabilizers, 17 Emulsifying Agents, 15 Film Formers & Plasticizers, 11 Co-Processed Excipients, 10 Surfactant & Foaming Agents, 9 Direct Compression, 7 Granulation, 7 Fillers, Diluents & Binders, 5 API Stability Enhancers, 5 Lubricants & Glidants, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Taste Masking, 2 Coloring Agents, 2 Rheology Modifiers, 1 Chewable & Orodispersible Aids, 1 Disintegrants & Superdisintegrants

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

DIGITAL CONTENT

12 NEWS #PharmaBuzz

12 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 5 Finished Drug Prices, 1 Annual Reports

1 US Medicaid Prescriptions
5 Finished Drug Prices
1 Annual Reports

MARKET PLACE

30 APIs, 7 FDF Dossiers

30 APIs
7 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 Others

1 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 4,717 Xls

Filters

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filter Applicant Reset all filters

7 All

01 1Glaxosmithkline South Africa (Pty) Ltd - Cape Town

02 2Johnson & Johnson (Pty) Ltd

03 2Novartis South Africa (Pty) Ltd

04 2Pfizer Laboratories (Pty) Ltd

filter Active Ingredients Reset all filters

7 All

01 5Polymyxin B

02 2Polymyxin B Sulphate

filter Dosage Form Reset all filters

7 All

01 1EAR

02 1EYO

03 3OIN

04 1OPD

05 1SUS

filter Brand Name Reset all filters

7 All

01 1Maxitrol

02 1Maxitrol Ointment

03 1Otosporin

04 2Polysporin

05 1Terracortril

06 1Terramycin topical ointment

List of Suppliers

Product Main Page

01

Glaxosmithkline South Africa (Pty) Ltd -...

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Glaxosmithkline South Africa (Pty) Ltd -...

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Regulatory Info : Generic

Registration Country : South Africa

Polymyxin B Sulphate

Brand Name : Otosporin

Dosage Form : EAR

Dosage Strength : 10000iu/ml

Packaging : 10X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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Product Web Link

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02

Johnson & Johnson (Pty) Ltd

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Johnson & Johnson (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Polymyxin B Sulphate

Brand Name : Polysporin

Dosage Form : OIN

Dosage Strength : 10000u/g

Packaging : 15X1u/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Johnson & Johnson (Pty) Ltd

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Johnson & Johnson (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Polymyxin B

Brand Name : Polysporin

Dosage Form : OIN

Dosage Strength : 10000u/g

Packaging : 15X1u/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

Pfizer Laboratories (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Polymyxin B

Brand Name : Terracortril

Dosage Form : SUS

Dosage Strength : 10000mg

Packaging : 15X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

Pfizer Laboratories (Pty) Ltd

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Pfizer Laboratories (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Polymyxin B

Brand Name : Terramycin topical ointment

Dosage Form : OIN

Dosage Strength : 10000mg

Packaging : 15X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

Novartis South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Polymyxin B

Brand Name : Maxitrol

Dosage Form : OPD

Dosage Strength : 6000iu

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Corporate PDF

07

Novartis South Africa (Pty) Ltd

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Novartis South Africa (Pty) Ltd

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Regulatory Info : Originator

Registration Country : South Africa

Polymyxin B

Brand Name : Maxitrol Ointment

Dosage Form : EYO

Dosage Strength : 6000iu

Packaging : 3.5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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