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

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Azithromycin, Unspecified Form
South Africa

DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

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Valsynthese, part of the SSE Group, is a CDMO focused on highly energetic and highly hazardous chemistry.

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Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

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Azithromycin, unspecified form

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

71 API Suppliers, 26 USDMF, 9 CEP/COS, 8 JDMF, 9 EU WC, 12 KDMF, 2 NDC API, 41 Listed Suppliers, $ API Reference Price

71 API Suppliers
26 USDMF
9 CEP/COS
8 JDMF
9 EU WC
12 KDMF
2 NDC API
41 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

INTERMEDIATES

6 Intermediates Suppliers

6 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

575 FDF Dossiers, 86 FDA Orange Book, 208 Europe, 13 Canada, 28 Australia, 27 South Africa, 213 Listed Dossiers

575 FDF Dossiers
86 FDA Orange Book
208 Europe
13 Canada
28 Australia
27 South Africa
213 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- EQ 250MG BASE, TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE;INJECTION - EQ 500MG BASE/VIAL, TABLET;ORAL - EQ 500MG BASE, FOR SUSPENSION, EXTENDED RELEASE;ORAL - EQ 2GM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TABLET;ORAL - EQ 600MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

1 Evonik, 4 Rochem International Inc, 20 SPI Pharma, 2 Seqens, 5 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 12 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, 2 The Dow Chemical Company, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

79 Fillers, Diluents & Binders, 53 Coating Systems & Additives, 39 Direct Compression, 33 Controlled & Modified Release, 30 Disintegrants & Superdisintegrants, 29 Thickeners and Stabilizers, 25 Granulation, 24 Taste Masking, 18 Chewable & Orodispersible Aids, 18 Lubricants & Glidants, 17 Co-Processed Excipients, 16 Parenteral, 15 Solubilizers, 15 Topical, 11 Film Formers & Plasticizers, 8 API Stability Enhancers, 7 Emulsifying Agents, 5 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Coloring Agents, 2 Surfactant & Foaming Agents

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

DIGITAL CONTENT

11 DATA COMPILATION #PharmaFlow, 97 NEWS #PharmaBuzz

11 DATA COMPILATION #PharmaFlow
97 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 208 Finished Drug Prices, 10 Annual Reports

1 US Medicaid Prescriptions
208 Finished Drug Prices
10 Annual Reports

MARKET PLACE

82 APIs, 38 FDF Dossiers, 1 Intermediates

82 APIs
38 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

2 US Patents, 3 Health Canada Patents

2 US Patents
3 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 8 USP, 9 Others

4 EDQM
8 USP
9 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 203 Xls

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27 All

01 1Pharmacare Limited, Woodmead

02 2Strides Pharma SA (Pty) Ltd

03 1Actor Pharma (Pty) Ltd

04 2Biotech Laboratories (Pty) Ltd

05 1Brimpharm Sa (Pty) Ltd

06 1Camox Pharmaceuticals (Pty) Ltd

07 2Cipla Medpro (Pty) Ltd

08 1Dezzo Trading 392 (Pty) Ltd

09 1Innovata Pharmaceuticals (Pty) Ltd

10 2Jubilant Pharma SA (Pty) Ltd

11 1Medicine Developers International CC

12 6Pfizer Laboratories (Pty) Ltd

13 1Pharmascript Pharmaceuticals Ltd

14 2Sandoz SA (Pty) Ltd

15 1Unicorn Pharmaceuticals (Pty) Ltd

16 1Xixia Pharmaceuticals (Pty) Ltd

17 1Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

27 All

01 2AZITHROMYCIN

02 24Azithromycin

03 1Azithromycin 500 mg

filter Dosage Form Reset all filters

27 All

01 3CAP

02 5FCT

03 1GRA

04 1INJ

05 1POI

06 3SUS

07 13TAB

filter Brand Name Reset all filters

27 All

01 1AZIMAX FORTE

02 2AZITHROMYCIN 500 BIOTECH

03 1Aspen Azithromycin

04 1Austell Azithromycin 500mg

05 1Azero

06 1Azithromycin Unicorn 500

07 1Azrotrin 500

08 1Binozyt 500

09 1Ceptomax 200 mg/5 ml

10 1Cipla Azithromycin 500

11 1Cipla Azithromycin 500 Inj

12 1Clamelle

13 1Sandoz Azithromycin 500 mg

14 1Ultreon 500mg

15 2Varimax

16 1Zeemide 500 Mg

17 1Zithract

18 1Zithrogen 500

19 1Zithrolide 250

20 1Zithrolide 500

21 2Zithromax 200mg/5ml

22 1Zithromax 500mg

23 1Zithromax IV

24 1Zithromax One

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

Pharma, Lab & Chemical Expo

Not Confirmed

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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

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02

Strides Pharma SA (Pty) Ltd

Pharma, Lab & Chemical Expo

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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

Azithromycin

Brand Name : Azrotrin 500

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 3X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Strides Pharma Science

Product Web Link

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03

Strides Pharma SA (Pty) Ltd

Pharma, Lab & Chemical Expo

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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

Azithromycin

Brand Name : Clamelle

Dosage Form : CAP

Dosage Strength : 250mg

Packaging : 4X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Strides Pharma Science

Product Web Link

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04

Actor Pharma (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Actor Pharma (Pty) Ltd

Pharma, Lab & Chemical Expo

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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

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05

Biotech Laboratories (Pty) Ltd

Pharma, Lab & Chemical Expo

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Biotech Laboratories (Pty) Ltd

Pharma, Lab & Chemical Expo

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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

06

Biotech Laboratories (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Biotech Laboratories (Pty) Ltd

Pharma, Lab & Chemical Expo

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

07

Brimpharm Sa (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Brimpharm Sa (Pty) Ltd

Pharma, Lab & Chemical Expo

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

08

Camox Pharmaceuticals (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Camox Pharmaceuticals (Pty) Ltd

Pharma, Lab & Chemical Expo

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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

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09

Cipla Medpro (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Cipla Medpro (Pty) Ltd

Pharma, Lab & Chemical Expo

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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

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Corporate PDF

10

Cipla Medpro (Pty) Ltd

Pharma, Lab & Chemical Expo

Not Confirmed

Cipla Medpro (Pty) Ltd

Pharma, Lab & Chemical Expo

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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

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