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

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Levofloxacin
South Africa

With Fermion, start the journey of your innovative API.

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Suanfarma CDMO offers integrated end-to-end solutions for development & commercialization of intermediates & APIs for small molecules.

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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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Levofloxacin

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

82 API Suppliers, 27 USDMF, 11 JDMF, 3 EU WC, 21 KDMF, 21 NDC API, 1 VMF, 27 Listed Suppliers, $ API Reference Price

82 API Suppliers
27 USDMF
11 JDMF
3 EU WC
21 KDMF
21 NDC API
1 VMF
27 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

552 FDF Dossiers, 119 FDA Orange Book, 217 Europe, 19 Canada, 42 South Africa, 155 Listed Dossiers

552 FDF Dossiers
119 FDA Orange Book
217 Europe
19 Canada
42 South Africa
155 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 250MG/10ML

TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION/DROPS;OPHTHALMIC - 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION/DROPS;OPHTHALMIC - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - 250MG/10ML

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 2 Rochem International Inc, 4 SPI Pharma, 7 DKSH, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 9 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 15 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 Ashland, 24 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 4 Finar, 11 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 30 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 3 Novo Excipients, 4 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 14 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

69 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 39 Disintegrants & Superdisintegrants, 30 Solubilizers, 27 Thickeners and Stabilizers, 27 Controlled & Modified Release, 26 Direct Compression, 24 Granulation, 23 Parenteral, 20 Topical, 18 Co-Processed Excipients, 15 Lubricants & Glidants, 14 Film Formers & Plasticizers, 13 Taste Masking, 9 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

69 Fillers, Diluents & Binders
46 Coating Systems & Additives
39 Disintegrants & Superdisintegrants
30 Solubilizers
27 Thickeners and Stabilizers
27 Controlled & Modified Release
26 Direct Compression
24 Granulation
23 Parenteral
20 Topical
18 Co-Processed Excipients
15 Lubricants & Glidants
14 Film Formers & Plasticizers
13 Taste Masking
9 Chewable & Orodispersible Aids
8 Emulsifying Agents
7 Rheology Modifiers
6 API Stability Enhancers
5 Coloring Agents
5 Empty Capsules
4 Vegetarian Capsules
3 Surfactant & Foaming Agents

DIGITAL CONTENT

48 News #PharmaBuzz

48 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 221 Regulatory FDF Prices, 1 Annual Reports

19 US Medicaid Prescriptions
221 Regulatory FDF Prices
1 Annual Reports

MARKET PLACE

31 APIs, 34 FDF Dossiers, 1 Intermediates

31 APIs
34 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

9 Health Canada Patents

9 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 13 Others

1 USP
13 Others

ANALYTICAL

1 BioAnalytical Methods, 2 Analytical Methods

1 BioAnalytical Methods
2 Analytical Methods

$ API Ref.Price (USD/KG) : 132 Xls

Filters

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42 All

01 4Acino Pharma (Pty) Ltd

02 2Adcock Ingram Limited

03 1Arya Pharma (Pty) Ltd

04 1Austell Pharmaceuticals (Pty) Ltd

05 4Cipla Medpro (Pty) Ltd

06 3Dr Reddy's Laboratories (Pty) Ltd

07 1Fresenius Kabi South Africa (Pty) Ltd

08 6Macleods Pharmaceuticals SA (Pty) Ltd

09 3Pharma Dynamics (Pty) Ltd

10 3Ranbaxy Pharmaceuticals (Pty) Ltd

11 4Ranbaxy S.A (Pty) Ltd

12 3Sandoz SA (Pty) Ltd

13 3Specpharm (Pty) Ltd

14 4Watson Pharma No. 1 (Pty) Ltd

filter Active Ingredients Reset all filters

42 All

01 4LEVOFLOXACIN

02 38Levofloxacin

filter Dosage Form Reset all filters

42 All

01 6FCT

02 11INF

03 1IV

04 24TAB

filter Brand Name Reset all filters

42 All

01 1ARTAV 250

02 2ARTAV 500

03 1ARTAV 750

04 3AVROKEL 250

05 3AVROKEL 500

06 1Alefnic 500 IV

07 1Levofloxacin Fresenius 5 mg/ml (100ml)

08 1Levofloxacin IV 5 mg/mL Austell

09 2Levonic 500 mg

10 1Levonic IV 500

11 1Levotav IV 250

12 1Levotav IV 500

13 1Lintrip 250

14 2Lintrip 500

15 1Litha Levofloxacin 250 mg

16 1Litha Levofloxacin 5 mg/ml

17 2Litha Levofloxacin 500 mg

18 1Sandoz Levofloxacin 250

19 2Sandoz Levofloxacin 500

20 1Spec Levofloxacin 250 IV

21 1Spec Levofloxacin 500

22 1Spec Levofloxacin 500 IV

23 1Tavaloxx 250

24 2Tavaloxx 500

25 1Tavaloxx 750

26 1Tavanic 250

27 2Tavanic 500

28 1Tavanic 750

29 1Tavanic I.V. 250

30 1Tavanic I.V. 500

31 1Tavanic I.V. 750

List of Suppliers

Product Main Page

01

Adcock Ingram Limited

Pharmex

Not Confirmed

Adcock Ingram Limited

Pharmex

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Levofloxacin

Brand Name : Levotav IV 500

Dosage Form : INF

Dosage Strength : 500mg/100ml

Packaging : 100X1mg/100ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

Adcock Ingram Limited

Pharmex

Not Confirmed

Adcock Ingram Limited

Pharmex

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Levofloxacin

Brand Name : Levotav IV 250

Dosage Form : INF

Dosage Strength : 250mg/50ml

Packaging : 50X1mg/50ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

Austell Pharmaceuticals (Pty) Ltd

Pharmex

Not Confirmed

Austell Pharmaceuticals (Pty) Ltd

Pharmex

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Levofloxacin

Brand Name : Levofloxacin IV 5 mg/mL Austell

Dosage Form : INF

Dosage Strength : 500mg/100ml

Packaging : 100X1mg/100ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

04

Cipla Medpro (Pty) Ltd

Pharmex

Not Confirmed

Cipla Medpro (Pty) Ltd

Pharmex

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Levofloxacin

Brand Name : Tavaloxx 500

Dosage Form : TAB

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

05

Cipla Medpro (Pty) Ltd

Pharmex

Not Confirmed

Cipla Medpro (Pty) Ltd

Pharmex

Not Confirmed

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Digital Content

Regulatory Info : Generic

Registration Country : South Africa

Levofloxacin

Brand Name : Tavaloxx 500

Dosage Form : TAB

Dosage Strength : 500mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

Acino Pharma (Pty) Ltd

Country

Pharmex

Not Confirmed

Acino Pharma (Pty) Ltd

Country

Pharmex

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Regulatory Info : Generic

Registration Country : South Africa

Levofloxacin

Brand Name : Litha Levofloxacin 5 mg/ml

Dosage Form : INF

Dosage Strength : 5mg/ml

Packaging : 100X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

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07

Acino Pharma (Pty) Ltd

Country

Pharmex

Not Confirmed

Acino Pharma (Pty) Ltd

Country

Pharmex

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Levofloxacin

Brand Name : Litha Levofloxacin 250 mg

Dosage Form : FCT

Dosage Strength : 250mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

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08

Acino Pharma (Pty) Ltd

Country

Pharmex

Not Confirmed

Acino Pharma (Pty) Ltd

Country

Pharmex

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Regulatory Info : Generic

Registration Country : South Africa

Levofloxacin

Brand Name : Litha Levofloxacin 500 mg

Dosage Form : FCT

Dosage Strength : 500mg

Packaging : 5X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

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09

Acino Pharma (Pty) Ltd

Country

Pharmex

Not Confirmed

Acino Pharma (Pty) Ltd

Country

Pharmex

Not Confirmed

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Country

Virtual Booth

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Regulatory Info : Generic

Registration Country : South Africa

Levofloxacin

Brand Name : Litha Levofloxacin 500 mg

Dosage Form : FCT

Dosage Strength : 500mg

Packaging : 10X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

Arya Pharma (Pty) Ltd

Country

Pharmex

Not Confirmed

Arya Pharma (Pty) Ltd

Country

Pharmex

Not Confirmed

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Regulatory Info : Generic

Registration Country : South Africa

Levofloxacin

Brand Name : Alefnic 500 IV

Dosage Form : IV

Dosage Strength : 500mg

Packaging : 100X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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