Azithromycin, unspecified form | South Africa Drug Approvals | Medicines Control Council | PharmaCompass.com

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Azithromycin, Unspecified Form
South Africa

SPI Pharma has been solving formulation challenges using superior functional materials.

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Azithromycin, unspecified form

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

82 API Suppliers, 26 USDMF, 9 CEP/COS, 8 JDMF, 9 EU WC, 12 KDMF, 3 NDC API, 44 Listed Suppliers, $ API Reference Price

82 API Suppliers
26 USDMF
9 CEP/COS
8 JDMF
9 EU WC
12 KDMF
3 NDC API
44 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

22 Drugs in Development

22 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

606 FDF Dossiers, 86 FDA Orange Book, 208 Europe, 14 Canada, 29 Australia, 25 South Africa, 244 Listed Dossiers

606 FDF Dossiers
86 FDA Orange Book
208 Europe
14 Canada
29 Australia
25 South Africa
244 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

FOR SUSPENSION;ORAL - EQ 1GM BASE/PACKET, FOR SUSPENSION;ORAL - EQ 100MG BASE/5ML, FOR SUSPENSION;ORAL - EQ 200MG BASE/5ML, TABLET;ORAL - EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM BASE/BOT

FOR SUSPENSION;ORAL - EQ 1GM BASE/PACKET
FOR SUSPENSION;ORAL - EQ 100MG BASE/5ML
FOR SUSPENSION;ORAL - EQ 200MG BASE/5ML
TABLET;ORAL - EQ 250MG BASE
TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
INJECTABLE;INJECTION - EQ 500MG BASE/VIAL
TABLET;ORAL - EQ 500MG BASE
FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM BASE/BOT

RELATED EXCIPIENT COMPANIES

5 Evonik, 4 Rochem International Inc, 21 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 6 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 18 BASF, 1 Clariant, 12 Corel Pharma Chem, 6 DFE Pharma, 2 Finar, 9 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 33 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 1 Lubrizol Life Science Health, 12 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 25 Roquette, 7 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

76 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 32 Controlled & Modified Release, 32 Disintegrants & Superdisintegrants, 30 Direct Compression, 30 Thickeners and Stabilizers, 29 Taste Masking, 25 Granulation, 19 Chewable & Orodispersible Aids, 17 Lubricants & Glidants, 16 Solubilizers, 15 Topical, 14 Parenteral, 14 Film Formers & Plasticizers, 14 Co-Processed Excipients, 7 API Stability Enhancers, 7 Emulsifying Agents, 7 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Surfactant & Foaming Agents

76 Fillers, Diluents & Binders
56 Coating Systems & Additives
32 Controlled & Modified Release
32 Disintegrants & Superdisintegrants
30 Direct Compression
30 Thickeners and Stabilizers
29 Taste Masking
25 Granulation
19 Chewable & Orodispersible Aids
17 Lubricants & Glidants
16 Solubilizers
15 Topical
14 Parenteral
14 Film Formers & Plasticizers
14 Co-Processed Excipients
7 API Stability Enhancers
7 Emulsifying Agents
7 Rheology Modifiers
5 Empty Capsules
4 Vegetarian Capsules
4 Coloring Agents
2 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 98 News #PharmaBuzz

1 Data Compilation #PharmaFlow
98 News #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 208 Regulatory FDF Prices, 10 Annual Reports

1 US Medicaid Prescriptions
208 Regulatory FDF Prices
10 Annual Reports

MARKET PLACE

86 APIs, 38 FDF Dossiers, 1 Intermediates

86 APIs
38 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

3 Health Canada Patents

3 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 6 USP, 9 Others

4 EDQM
6 USP
9 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 202 Xls

Filters

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Filters

FILTER :

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25 All

01 1Pharmacare Limited, Woodmead

02 1Actor Pharma (Pty) Ltd

03 2Biotech Laboratories (Pty) Ltd

04 1Brimpharm Sa (Pty) Ltd

05 1Camox Pharmaceuticals (Pty) Ltd

06 2Cipla Medpro (Pty) Ltd

07 1Dezzo Trading 392 (Pty) Ltd

08 1Innovata Pharmaceuticals (Pty) Ltd

09 2Jubilant Pharma SA (Pty) Ltd

10 1Medicine Developers International CC

11 6Pfizer Laboratories (Pty) Ltd

12 1Pharmascript Pharmaceuticals Ltd

13 2Sandoz SA (Pty) Ltd

14 1Unicorn Pharmaceuticals (Pty) Ltd

15 1Xixia Pharmaceuticals (Pty) Ltd

16 1Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

25 All

01 2AZITHROMYCIN

02 22Azithromycin

03 1Azithromycin 500 mg

filter Dosage Form Reset all filters

25 All

01 2CAP

02 5FCT

03 1GRA

04 1INJ

05 1POI

06 3SUS

07 12TAB

filter Brand Name Reset all filters

25 All

01 1AZIMAX FORTE

02 2AZITHROMYCIN 500 BIOTECH

03 1Aspen Azithromycin

04 1Austell Azithromycin 500mg

05 1Azero

06 1Azithromycin Unicorn 500

07 1Binozyt 500

08 1Ceptomax 200 mg/5 ml

09 1Cipla Azithromycin 500

10 1Cipla Azithromycin 500 Inj

11 1Sandoz Azithromycin 500 mg

12 1Ultreon 500mg

13 2Varimax

14 1Zeemide 500 Mg

15 1Zithract

16 1Zithrogen 500

17 1Zithrolide 250

18 1Zithrolide 500

19 2Zithromax 200mg/5ml

20 1Zithromax 500mg

21 1Zithromax IV

22 1Zithromax One

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

STLE Annual Meeting

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Azithromycin

Brand Name : Aspen Azithromycin

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 3X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Actor Pharma (Pty) Ltd

STLE Annual Meeting

Not Confirmed

Actor Pharma (Pty) Ltd

STLE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Azithromycin

Brand Name : Zithract

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 3X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Biotech Laboratories (Pty) Ltd

STLE Annual Meeting

Not Confirmed

Biotech Laboratories (Pty) Ltd

STLE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Azithromycin

Brand Name : AZITHROMYCIN 500 BIOTECH

Dosage Form : TAB

Dosage Strength : 500MG

Packaging : 2X1MG

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Biotech Laboratories (Pty) Ltd

STLE Annual Meeting

Not Confirmed

Biotech Laboratories (Pty) Ltd

STLE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Azithromycin

Brand Name : AZITHROMYCIN 500 BIOTECH

Dosage Form : TAB

Dosage Strength : 500MG

Packaging : 3X1MG

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

Brimpharm Sa (Pty) Ltd

STLE Annual Meeting

Not Confirmed

Brimpharm Sa (Pty) Ltd

STLE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Azithromycin

Brand Name : Zeemide 500 Mg

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 3X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Camox Pharmaceuticals (Pty) Ltd

STLE Annual Meeting

Not Confirmed

Camox Pharmaceuticals (Pty) Ltd

STLE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Azithromycin

Brand Name : Austell Azithromycin 500mg

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 3X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Website

Corporate PDF

07

Cipla Medpro (Pty) Ltd

STLE Annual Meeting

Not Confirmed

Cipla Medpro (Pty) Ltd

STLE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Azithromycin

Brand Name : Cipla Azithromycin 500 Inj

Dosage Form : INJ

Dosage Strength : 500mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Cipla Medpro (Pty) Ltd

STLE Annual Meeting

Not Confirmed

Cipla Medpro (Pty) Ltd

STLE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Azithromycin

Brand Name : Cipla Azithromycin 500

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 3X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Innovata Pharmaceuticals (Pty) Ltd

STLE Annual Meeting

Not Confirmed

Innovata Pharmaceuticals (Pty) Ltd

STLE Annual Meeting

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

AZITHROMYCIN

Brand Name : Ceptomax 200 mg/5 ml

Dosage Form : SUS

Dosage Strength : 200.0 mg/ 5.0 mlml

Packaging : 30 mlX1ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Dezzo Trading 392 (Pty) Ltd

Country

STLE Annual Meeting

Not Confirmed

Dezzo Trading 392 (Pty) Ltd

Country

STLE Annual Meeting

Not Confirmed

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Country

Virtual Booth

Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Azithromycin

Brand Name : Varimax

Dosage Form : CAP

Dosage Strength : 250mg

Packaging : 6X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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