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

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Levaquin, Tavanic, Levofloxacin
South Africa

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

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IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

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IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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medac CDMO: Tailored CDMO services for injectables in syringes, cartridges & vials – aseptic, reliable, flexible and a solution ahead.

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Coral

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ICE Pharma offers a unique range of bile acid products and best-in-class services for the pharmaceutical industry.

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Levaquin, Tavanic, Levofloxacin

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

83 API Suppliers, 27 USDMF, 11 JDMF, 4 EU WC, 21 KDMF, 21 NDC API, 28 Listed Suppliers, $ API Reference Price

83 API Suppliers
27 USDMF
11 JDMF
4 EU WC
21 KDMF
21 NDC API
28 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

50 Drugs in Development

50 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

531 FDF Dossiers, 119 FDA Orange Book, 181 Europe, 19 Canada, 53 South Africa, 159 Listed Dossiers

531 FDF Dossiers
119 FDA Orange Book
181 Europe
19 Canada
53 South Africa
159 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TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - 1.5% **Federal Register determination that product was not discontinued or withdrawn for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, 9 Boai NKY Pharmaceuticals Ltd, 6 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 5 Kirsch Pharma, 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 CD Formulation, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 4 Finar, 11 Gangwal Chemicals, 4 Ideal Cures, 4 Ingredion Pharma Solutions, 20 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

59 Fillers, Diluents & Binders, 43 Coating Systems & Additives, 39 Disintegrants & Superdisintegrants, 30 Solubilizers, 29 Thickeners and Stabilizers, 28 Direct Compression, 27 Parenteral, 27 Granulation, 22 Controlled & Modified Release, 20 Topical, 15 Lubricants & Glidants, 14 Film Formers & Plasticizers, 13 Co-Processed Excipients, 13 Taste Masking, 11 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents

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

DIGITAL CONTENT

48 News #PharmaBuzz

48 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 146 Regulatory FDF Prices, 1 Annual Reports

19 US Medicaid Prescriptions
146 Regulatory FDF Prices
1 Annual Reports

MARKET PLACE

31 APIs, 34 FDF Dossiers, 1 Intermediates

31 APIs
34 FDF Dossiers
1 Intermediates

PATENTS & EXCLUSIVITIES

5 Health Canada Patents

5 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 17 Others

1 USP
17 Others

ANALYTICAL

1 BioAnalytical Methods, 2 Analytical Methods

1 BioAnalytical Methods
2 Analytical Methods

$ API Ref.Price (USD/KG) : 122 Xls

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53 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

15 7Winthrop Pharmaceuticals (Pty) Ltd

16 4Zydus Healthcare SA (Pty) Ltd

filter Active Ingredients Reset all filters

53 All

01 4LEVOFLOXACIN

02 49Levofloxacin

filter Dosage Form Reset all filters

53 All

01 6FCT

02 11INF

03 3INJ

04 1IV

05 32TAB

filter Brand Name Reset all filters

53 All

01 1ARTAV 250

02 2ARTAV 500

03 1ARTAV 750

04 3AVROKEL 250

05 3AVROKEL 500

06 1Alefnic 500 IV

07 1Arylevo 500

08 1Levofloxacin Fresenius 5 mg/ml (100ml)

09 1Levofloxacin IV 5 mg/mL Austell

10 1Levofloxacin Winthrop 750

11 1Levofloxacin Winthrop I.V. 250

12 1Levofloxacin Winthrop I.V. 500

13 1Levofloxacin Winthrop I.V. 750

14 1Levofloxacin-Winthrop 250

15 2Levofloxacin-Winthrop 500

16 2Levonic 500 mg

17 1Levonic IV 500

18 1Levotav IV 250

19 1Levotav IV 500

20 1Lintrip 250

21 2Lintrip 500

22 1Litha Levofloxacin 250 mg

23 1Litha Levofloxacin 5 mg/ml

24 2Litha Levofloxacin 500 mg

25 1Sandoz Levofloxacin 250

26 2Sandoz Levofloxacin 500

27 1Spec Levofloxacin 250 IV

28 1Spec Levofloxacin 500

29 1Spec Levofloxacin 500 IV

30 1Tavaloxx 250

31 2Tavaloxx 500

32 1Tavaloxx 750

33 1Tavanic 250

34 2Tavanic 500

35 1Tavanic 750

36 1Tavanic I.V. 250

37 1Tavanic I.V. 500

38 1Tavanic I.V. 750

39 1Zybact 250 mg

40 2Zybact 500 mg

List of Suppliers

Product Main Page

01

Adcock Ingram Limited

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Adcock Ingram Limited

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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

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02

Adcock Ingram Limited

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Adcock Ingram Limited

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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

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03

Austell Pharmaceuticals (Pty) Ltd

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Austell Pharmaceuticals (Pty) Ltd

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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

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04

Cipla Medpro (Pty) Ltd

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Cipla Medpro (Pty) Ltd

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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

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05

Cipla Medpro (Pty) Ltd

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Cipla Medpro (Pty) Ltd

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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

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06

Acino Pharma (Pty) Ltd

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Acino Pharma (Pty) Ltd

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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

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07

Acino Pharma (Pty) Ltd

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Acino Pharma (Pty) Ltd

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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

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08

Acino Pharma (Pty) Ltd

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Acino Pharma (Pty) Ltd

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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

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09

Acino Pharma (Pty) Ltd

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Acino Pharma (Pty) Ltd

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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

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10

Arya Pharma (Pty) Ltd

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Arya Pharma (Pty) Ltd

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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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