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

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Sulfate, Polymyxin B
South Africa

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Jai Radhe Sales is your partner for all your sourcing needs.

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xyz-pharma-m-2024-10-07

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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xyz-pharma-m-2024-10-07

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Sulfate, Polymyxin B

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

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

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

DEVELOPMENTS

7 Drugs in Development

7 Drugs in Development

FINISHED DOSAGE FORMULATIONS

145 FDF Dossiers, 95 FDA Orange Book, 7 Europe, 19 Canada, 8 South Africa, 16 Listed Dossiers

145 FDF Dossiers
95 FDA Orange Book
7 Europe
19 Canada
8 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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, OINTMENT;OPHTHALMIC - EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM, SOLUTION/DROPS;OPHTHALMIC - 10,000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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Jai Radhe Sales, 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 Fillers, Diluents & Binders, 7 Granulation, 5 Lubricants & Glidants, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 3 Taste Masking, 2 Rheology Modifiers, 2 Coloring Agents, 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 Fillers, Diluents & Binders
7 Granulation
5 Lubricants & Glidants
5 Empty Capsules
5 API Stability Enhancers
4 Vegetarian Capsules
3 Taste Masking
2 Rheology Modifiers
2 Coloring Agents
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

29 APIs, 7 FDF Dossiers

29 APIs
7 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 Others

1 EDQM
1 USP
1 Others

$ API Ref.Price (USD/KG) : 4,741 Xls

Filters

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filter Applicant Reset all filters

8 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

05 1Pharmacorp (Pty) Ltd

filter Active Ingredients Reset all filters

8 All

01 5Polymyxin B

02 2Polymyxin B Sulphate

03 1Polymyxin B sulphate

filter Dosage Form Reset all filters

8 All

01 1EAR

02 1EYO

03 3OIN

04 1OPD

05 1PVC

06 1SUS

filter Brand Name Reset all filters

8 All

01 1Maxitrol

02 1Maxitrol Ointment

03 1Otosporin

04 1POLYGYNAX®

05 2Polysporin

06 1Terracortril

07 1Terramycin topical ointment

List of Suppliers

Product Main Page

01

Glaxosmithkline South Africa (Pty) Ltd -...

CPhI India 2024

Not Confirmed

Glaxosmithkline South Africa (Pty) Ltd -...

CPhI India 2024

Not Confirmed

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Digital Content

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Johnson & Johnson (Pty) Ltd

CPhI India 2024

Not Confirmed

Johnson & Johnson (Pty) Ltd

CPhI India 2024

Not Confirmed

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Digital Content

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Johnson & Johnson (Pty) Ltd

CPhI India 2024

Not Confirmed

Johnson & Johnson (Pty) Ltd

CPhI India 2024

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Pfizer Laboratories (Pty) Ltd

CPhI India 2024

Not Confirmed

Pfizer Laboratories (Pty) Ltd

CPhI India 2024

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

05

Pfizer Laboratories (Pty) Ltd

CPhI India 2024

Not Confirmed

Pfizer Laboratories (Pty) Ltd

CPhI India 2024

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

06

Novartis South Africa (Pty) Ltd

Country

CPhI India 2024

Not Confirmed

Novartis South Africa (Pty) Ltd

Country

CPhI India 2024

Not Confirmed

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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

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

07

Novartis South Africa (Pty) Ltd

Country

CPhI India 2024

Not Confirmed

Novartis South Africa (Pty) Ltd

Country

CPhI India 2024

Not Confirmed

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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

Portfolio PDF

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Virtual Booth

Digital Content

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08

Pharmacorp (Pty) Ltd

Country

CPhI India 2024

Not Confirmed

Pharmacorp (Pty) Ltd

Country

CPhI India 2024

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Polymyxin B sulphate

Brand Name : POLYGYNAX®

Dosage Form : PVC

Dosage Strength : 35000IU

Packaging : 12X1IU

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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