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

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Vancomycin
South Africa

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Strides Vancomycin Hydrochloride

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xyz-pharma-m-2024-10-07

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Symbiotech Vancomycin

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xyz-pharma-m-2024-10-07

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Vancomycin

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 20 USDMF, 16 CEP/COS, 8 JDMF, 1 EU WC, 13 KDMF, 20 NDC API, 21 Listed Suppliers, $ API Reference Price

43 API Suppliers
20 USDMF
16 CEP/COS
8 JDMF
1 EU WC
13 KDMF
20 NDC API
21 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

FINISHED DOSAGE FORMULATIONS

322 FDF Dossiers, 142 FDA Orange Book, 76 Europe, 27 Canada, 10 Australia, 13 South Africa, 54 Listed Dossiers

322 FDF Dossiers
142 FDA Orange Book
76 Europe
27 Canada
10 Australia
13 South Africa
54 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

POWDER;INTRAVENOUS - EQ 1.25GM BASE/VIAL, POWDER;INTRAVENOUS - EQ 1.5GM BASE/VIAL, POWDER;INTRAVENOUS - EQ 1.75GM BASE/VIAL, POWDER;INTRAVENOUS - EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, POWDER;INTRAVENOUS - EQ 2GM BASE/VIAL, POWDER;INTRAVENOUS - EQ 750MG BASE/VIAL, POWDER;INTRAVENOUS, ORAL - EQ 10GM BASE/VIAL, POWDER;INTRAVENOUS, ORAL - EQ 1GM BASE/VIAL, POWDER;INTRAVENOUS, ORAL - EQ 500MG BASE/VIAL, POWDER;INTRAVENOUS, ORAL - EQ 5GM BASE/VIAL, CAPSULE;ORAL - EQ 125MG BASE, CAPSULE;ORAL - EQ 250MG BASE

POWDER;INTRAVENOUS - EQ 1.25GM BASE/VIAL
POWDER;INTRAVENOUS - EQ 1.5GM BASE/VIAL
POWDER;INTRAVENOUS - EQ 1.75GM BASE/VIAL
POWDER;INTRAVENOUS - EQ 250MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
POWDER;INTRAVENOUS - EQ 2GM BASE/VIAL
POWDER;INTRAVENOUS - EQ 750MG BASE/VIAL
POWDER;INTRAVENOUS, ORAL - EQ 10GM BASE/VIAL
POWDER;INTRAVENOUS, ORAL - EQ 1GM BASE/VIAL
POWDER;INTRAVENOUS, ORAL - EQ 500MG BASE/VIAL
POWDER;INTRAVENOUS, ORAL - EQ 5GM BASE/VIAL
CAPSULE;ORAL - EQ 125MG BASE
CAPSULE;ORAL - EQ 250MG BASE

RELATED EXCIPIENT COMPANIES

2 Seqens, 7 DKSH, 1 Faran Shimi Pharmaceutical, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 6 Actylis, 14 BASF, 2 Finar, 2 Gangwal Chemicals, 3 Lonza Capsugel, 2 Nomisma Healthcare, 1 Pluviaendo, 1 Qualicaps, 6 Roquette, 1 Seppic, 1 Valens Pharmachem

2 Seqens
7 DKSH
1 Faran Shimi Pharmaceutical
2 Nanjing Well Pharmaceutical
4 ACG Worldwide
6 Actylis
14 BASF
2 Finar
2 Gangwal Chemicals
3 Lonza Capsugel
2 Nomisma Healthcare
1 Pluviaendo
1 Qualicaps
6 Roquette
1 Seppic
1 Valens Pharmachem

EXCIPIENTS BY APPLICATIONS

12 Topical, 9 Coating Systems & Additives, 9 Thickeners and Stabilizers, 8 Parenteral, 8 Empty Capsules, 6 Solubilizers, 6 Film Formers & Plasticizers, 6 Fillers, Diluents & Binders, 5 Controlled & Modified Release, 4 Granulation, 3 Coloring Agents, 3 Taste Masking, 3 Lubricants & Glidants, 1 Direct Compression, 1 Emulsifying Agents, 1 Surfactant & Foaming Agents

12 Topical
9 Coating Systems & Additives
9 Thickeners and Stabilizers
8 Parenteral
8 Empty Capsules
6 Solubilizers
6 Film Formers & Plasticizers
6 Fillers, Diluents & Binders
5 Controlled & Modified Release
4 Granulation
3 Coloring Agents
3 Taste Masking
3 Lubricants & Glidants
1 Direct Compression
1 Emulsifying Agents
1 Surfactant & Foaming Agents

DIGITAL CONTENT

5 DATA COMPILATION #PharmaFlow, 94 NEWS #PharmaBuzz

5 DATA COMPILATION #PharmaFlow
94 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 69 Finished Drug Prices, 2 Annual Reports

2 US Medicaid Prescriptions
69 Finished Drug Prices
2 Annual Reports

MARKET PLACE

38 APIs, 20 FDF Dossiers

38 APIs
20 FDF Dossiers

PATENTS & EXCLUSIVITIES

60 US Patents, 4 US Exclusivities

60 US Patents
4 US Exclusivities

REF. STANDARDS & IMPURITIES

1 EDQM, 2 USP, 4 Others

1 EDQM
2 USP
4 Others

ANALYTICAL

1 Analytical Methods

1 Analytical Methods

$ API Ref.Price (USD/KG) : 639 Xls

Filters

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FILTER :

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13 All

01 2Pharmacare Limited, Woodmead

02 1Strides Pharma SA (Pty) Ltd

03 2Gulf Drug Company (Pty) Ltd

04 2Mylan (Pty) Ltd

05 3Pharmaplan (Pty) Ltd

06 3Sandoz SA (Pty) Ltd

filter Active Ingredients Reset all filters

13 All

01 1VANCOMYCIN HCL

02 1VANCOMYCIN HCl

03 11Vancomycin

filter Dosage Form Reset all filters

13 All

01 2CAP

02 2INF

03 5INJ

04 4POI

filter Brand Name Reset all filters

13 All

01 1Aspen Vancomycin CP 1 000

02 1Aspen Vancomycin CP 500

03 1Comavyn 125

04 1Gulf Vancomycin 0,5 g

05 1Gulf Vancomycin 1,0 g

06 1Mylan Vancomycin 1 g

07 1Mylan Vancomycin 500 mg

08 1VANCOMYCIN- FAULDING 1G

09 1VANCOMYCIN- FAULDING 500 mg

10 1Vancocin CP 1 g

11 1Vancocin Cp

12 1Vancocin Cp 500 mg

13 1Vancomycin-faulding pow f/injection

Chemwerth Vancomycin Hydrochloride

List of Suppliers

Product Main Page

01

Strides Pharma SA (Pty) Ltd

CPhI India 2024

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Comavyn 125

Dosage Form : CAP

Dosage Strength : 125mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Strides Pharma Science

Product Web Link

Digital Content

02

Pharmacare Limited, Woodmead

Medlab Asia & Asia Health

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Aspen Vancomycin CP 500

Dosage Form : POI

Dosage Strength : 500mg/10ml

Packaging : 10X10mg/10ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Pharmacare Limited, Woodmead

Medlab Asia & Asia Health

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Aspen Vancomycin CP 1 000

Dosage Form : POI

Dosage Strength : 1g/30 ml

Packaging : 30X10g/30 ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

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04

Gulf Drug Company (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Gulf Drug Company (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Gulf Vancomycin 0,5 g

Dosage Form : POI

Dosage Strength : 0.5g

Packaging : 10X10g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Gulf Drug Company (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Gulf Drug Company (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Gulf Vancomycin 1,0 g

Dosage Form : POI

Dosage Strength : 1g

Packaging : 20X10g

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Pharmaplan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Pharmaplan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

VANCOMYCIN HCL

Brand Name : Vancomycin-faulding pow f/injection

Dosage Form : INJ

Dosage Strength : 50mg/ml

Packaging : 10X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Pharmaplan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Pharmaplan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

VANCOMYCIN HCl

Brand Name : VANCOMYCIN- FAULDING 500 mg

Dosage Form : INJ

Dosage Strength : 500mg/10ml

Packaging : 100X1mg/10ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Pharmaplan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Pharmaplan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Brand Name : VANCOMYCIN- FAULDING 1G

Dosage Form : INJ

Dosage Strength : 1000mg/20ml

Packaging : 1X1mg/20ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

09

Mylan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Mylan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Mylan Vancomycin 500 mg

Dosage Form : INF

Dosage Strength : 500mg/10ml

Packaging : 10X10mg/10ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Mylan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

Mylan (Pty) Ltd

Medlab Asia & Asia Health

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Brand Name : Mylan Vancomycin 1 g

Dosage Form : INF

Dosage Strength : 1g/20ml

Packaging : 20X10g/20ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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