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

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Avelox
South Africa

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

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TransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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xyz-pharma-m-2025-01-06

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LEBSA- Your strategic API source for niche molecules.

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Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

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xyz-pharma-m-2025-01-06

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Avelox

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

74 API Suppliers, 24 USDMF, 22 CEP/COS, 5 JDMF, 17 EU WC, 15 KDMF, 18 NDC API, 44 Listed Suppliers, $ API Reference Price

74 API Suppliers
24 USDMF
22 CEP/COS
5 JDMF
17 EU WC
15 KDMF
18 NDC API
44 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

115 FDF Dossiers, 29 FDA Orange Book, 28 Europe, 16 Canada, 25 South Africa, 17 Listed Dossiers

115 FDF Dossiers
29 FDA Orange Book
28 Europe
16 Canada
25 South Africa
17 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Rochem International Inc, 7 SPI Pharma, 2 Seqens, 7 DKSH, 1 Pharm-RX Chemical, 4 Faran Shimi Pharmaceutical, 5 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 15 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 8 Actylis, 1 Aeon Procare, 2 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 12 BASF, 2 Clariant, 10 Corel Pharma Chem, 1 Curia, 6 DFE Pharma, 1 Finar, 10 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 31 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 27 Roquette, 13 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 4 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders, 54 Coating Systems & Additives, 33 Direct Compression, 32 Disintegrants & Superdisintegrants, 29 Controlled & Modified Release, 27 Thickeners and Stabilizers, 22 Lubricants & Glidants, 22 Film Formers & Plasticizers, 22 Solubilizers, 18 Parenteral, 17 Co-Processed Excipients, 17 Granulation, 17 Topical, 12 Taste Masking, 10 Chewable & Orodispersible Aids, 9 Emulsifying Agents, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 1 Soft Gelatin

73 Fillers, Diluents & Binders
54 Coating Systems & Additives
33 Direct Compression
32 Disintegrants & Superdisintegrants
29 Controlled & Modified Release
27 Thickeners and Stabilizers
22 Lubricants & Glidants
22 Film Formers & Plasticizers
22 Solubilizers
18 Parenteral
17 Co-Processed Excipients
17 Granulation
17 Topical
12 Taste Masking
10 Chewable & Orodispersible Aids
9 Emulsifying Agents
8 API Stability Enhancers
7 Rheology Modifiers
5 Empty Capsules
5 Coloring Agents
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 18 NEWS #PharmaBuzz

1 DATA COMPILATION #PharmaFlow
18 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 18 Finished Drug Prices, 4 Annual Reports

3 US Medicaid Prescriptions
18 Finished Drug Prices
4 Annual Reports

MARKET PLACE

28 APIs, 1 FDF Dossiers

28 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

2 US Patents, 18 Health Canada Patents

2 US Patents
18 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 3 Others

2 EDQM
1 USP
3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 381 Xls

Filters

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25 All

01 2Pharmacare Limited, Woodmead

02 3Austell Laboratories (Pty) Ltd

03 5Bayer (Pty) Ltd

04 1Cipla Medpro (Pty) Ltd

05 2Dr Reddy's Laboratories (Pty) Ltd

06 1Fresenius Kabi South Africa (Pty) Ltd

07 1Gen-Eye (Pty) Ltd

08 1Hetero Drugs South Africa (Pty) Ltd

09 2Macleods Pharmaceuticals SA (Pty) Ltd

10 1Novartis South Africa (Pty) Ltd

11 2Ranbaxy Pharmaceuticals (Pty) Ltd

12 4Ranbaxy S.A (Pty) Ltd

filter Active Ingredients Reset all filters

25 All

01 23Moxifloxacin

02 2Moxifloxacin Hydrochloride

filter Dosage Form Reset all filters

25 All

01 9FCT

02 2INF

03 1INJ

04 2OPD

05 11TAB

filter Brand Name Reset all filters

25 All

01 1Austell Moxifloxacin IV 400mg/250ml

02 2Avebact 400

03 1Avelon IV 400mg 250ml

04 1Avelon Tabs 10S

05 1Avelon Tabs 5S

06 2Avoxa

07 2DRL Moxifloxacin

08 1Floxave 400

09 1GENFLOC

10 2Litares

11 2Lonxave 400

12 1MOXIFLOXACIN 400mg/250ml FRESENIUS

13 1Mofloxx

14 2Moxibay Tablets

15 2Numoxx 400

16 2Ran-Moxifloxacin

17 1Vigamox Eye Drops

List of Suppliers

Product Main Page

01

Pharmacare Limited, Woodmead

Pharmatech Expo 2025

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Moxifloxacin

Brand Name : Litares

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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02

Pharmacare Limited, Woodmead

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Moxifloxacin

Brand Name : Litares

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Aspen API Comapny Banner

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03

Austell Laboratories (Pty) Ltd

Pharmatech Expo 2025

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Austell Laboratories (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Moxifloxacin

Brand Name : Austell Moxifloxacin IV 400mg/250ml

Dosage Form : INF

Dosage Strength : 400mg/250ml

Packaging : 250X1mg/250ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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04

Austell Laboratories (Pty) Ltd

Pharmatech Expo 2025

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Austell Laboratories (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Moxifloxacin

Brand Name : Avoxa

Dosage Form : FCT

Dosage Strength : 400mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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05

Austell Laboratories (Pty) Ltd

Pharmatech Expo 2025

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Austell Laboratories (Pty) Ltd

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Moxifloxacin

Brand Name : Avoxa

Dosage Form : FCT

Dosage Strength : 400mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

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Corporate PDF

06

Bayer (Pty) Ltd

Pharmatech Expo 2025

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Bayer (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Moxifloxacin

Brand Name : Moxibay Tablets

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

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07

Bayer (Pty) Ltd

Pharmatech Expo 2025

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Bayer (Pty) Ltd

Pharmatech Expo 2025

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Moxifloxacin

Brand Name : Moxibay Tablets

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

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08

Bayer (Pty) Ltd

Pharmatech Expo 2025

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Bayer (Pty) Ltd

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Moxifloxacin

Brand Name : Avelon Tabs 5S

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

09

Bayer (Pty) Ltd

Pharmatech Expo 2025

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Bayer (Pty) Ltd

Pharmatech Expo 2025

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Moxifloxacin

Brand Name : Avelon Tabs 10S

Dosage Form : TAB

Dosage Strength : 400mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

10

Bayer (Pty) Ltd

Pharmatech Expo 2025

Not Confirmed

Bayer (Pty) Ltd

Pharmatech Expo 2025

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Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Moxifloxacin

Brand Name : Avelon IV 400mg 250ml

Dosage Form : INJ

Dosage Strength : 400mg/250ml

Packaging : 250X1mg/250ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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