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

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Neomycin 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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Neomycin Sulfate

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

23 API Suppliers, 11 USDMF, 5 CEP/COS, 2 JDMF, 1 KDMF, 22 NDC API, 10 VMF, 10 Listed Suppliers, $ API Reference Price

23 API Suppliers
11 USDMF
5 CEP/COS
2 JDMF
1 KDMF
22 NDC API
10 VMF
10 Listed Suppliers
$ API Reference Price

FINISHED DOSAGE FORMULATIONS

158 FDF Dossiers, 114 FDA Orange Book, 4 Europe, 7 Canada, 3 South Africa, 30 Listed Dossiers

158 FDF Dossiers
114 FDA Orange Book
4 Europe
7 Canada
3 South Africa
30 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- 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML, OINTMENT;OPHTHALMIC - EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM

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**
SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML
OINTMENT;OPHTHALMIC - EQ 400 UNITS/GM;EQ 3.5MG BASE/GM;EQ 10,000 UNITS/GM

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 5 DKSH, 3 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 12 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 19 Actylis, 1 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 32 BASF, 10 Corel Pharma Chem, 3 DFE Pharma, 4 Finar, 10 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 35 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 11 Roquette, 17 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 3 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

52 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 42 Solubilizers, 39 Topical, 28 Parenteral, 25 Direct Compression, 24 Controlled & Modified Release, 21 Thickeners and Stabilizers, 21 Film Formers & Plasticizers, 19 Lubricants & Glidants, 18 Emulsifying Agents, 16 Granulation, 15 Co-Processed Excipients, 10 Surfactant & Foaming Agents, 9 Taste Masking, 6 Chewable & Orodispersible Aids, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Rheology Modifiers, 2 Disintegrants & Superdisintegrants, 1 Soft Gelatin

52 Fillers, Diluents & Binders
47 Coating Systems & Additives
42 Solubilizers
39 Topical
28 Parenteral
25 Direct Compression
24 Controlled & Modified Release
21 Thickeners and Stabilizers
21 Film Formers & Plasticizers
19 Lubricants & Glidants
18 Emulsifying Agents
16 Granulation
15 Co-Processed Excipients
10 Surfactant & Foaming Agents
9 Taste Masking
6 Chewable & Orodispersible Aids
6 API Stability Enhancers
5 Empty Capsules
4 Vegetarian Capsules
4 Coloring Agents
2 Rheology Modifiers
2 Disintegrants & Superdisintegrants
1 Soft Gelatin

DIGITAL CONTENT

6 NEWS #PharmaBuzz

6 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 5 Finished Drug Prices

1 US Medicaid Prescriptions
5 Finished Drug Prices

MARKET PLACE

59 APIs, 4 FDF Dossiers

59 APIs
4 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 2 Others

3 EDQM
1 USP
2 Others

$ API Ref.Price (USD/KG) : 390 Xls

Filters

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FILTER :

filter Applicant Reset all filters

3 All

01 1AbbVie (Pty) Ltd

02 1Glaxosmithkline South Africa (Pty) Ltd - Cape Town

03 1Glenmark Pharmaceuticals South Africa (Pty) Ltd

filter Active Ingredients Reset all filters

3 All

01 1Neomycin Sulphate

02 2Neomycin sulphate

filter Dosage Form Reset all filters

3 All

01 1CRE

02 1EAR

03 1OPD

filter Brand Name Reset all filters

3 All

01 1FML Neo Liquifilm Ophthalmic Suspension

02 1Naseptin

03 1Otosporin

List of Suppliers

Product Main Page

01

AbbVie (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Neomycin sulphate

Brand Name : FML Neo Liquifilm Ophthalmic Suspension

Dosage Form : OPD

Dosage Strength : 5mg/ml

Packaging : 5X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Abbvie Company Banner

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02

Glenmark Pharmaceuticals South Africa (P...

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Glenmark Pharmaceuticals South Africa (P...

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Neomycin sulphate

Brand Name : Naseptin

Dosage Form : CRE

Dosage Strength : 3250iu/g

Packaging : 15X1mg/g

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

Glaxosmithkline South Africa (Pty) Ltd -...

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Glaxosmithkline South Africa (Pty) Ltd -...

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Neomycin Sulphate

Brand Name : Otosporin

Dosage Form : EAR

Dosage Strength : 3400iu/ml

Packaging : 10X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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