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Levofloxacin

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 27 USDMF, 11 JDMF, 7 EU WC, 21 KDMF, 23 NDC API, 1 VMF, 27 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

560 FDF Dossiers, 119 FDA Orange Book, 217 Europe, 19 Canada, 56 South Africa, 149 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TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 250MG/10ML

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, 24 BASF, 1 Bioplus Life Sciences, 1 Clariant, 10 Corel Pharma Chem, 6 DFE Pharma, 4 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 30 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 1 Nanjing Bold Chemical, 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, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

68 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 38 Disintegrants & Superdisintegrants, 30 Solubilizers, 28 Thickeners and Stabilizers, 27 Direct Compression, 27 Controlled & Modified Release, 24 Granulation, 23 Parenteral, 19 Topical, 15 Lubricants & Glidants, 15 Film Formers & Plasticizers, 13 Co-Processed Excipients, 13 Taste Masking, 9 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 7 Rheology Modifiers, 6 API Stability Enhancers, 5 Empty Capsules, 5 Coloring Agents, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

48 News #PharmaBuzz

48 News #PharmaBuzz

GLOBAL SALES INFORMATION

221 Regulatory FDF Prices, 1 Annual Reports

MARKET PLACE

31 APIs, 34 FDF Dossiers, 1 Intermediates

PATENTS & EXCLUSIVITIES

9 Health Canada Patents

9 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 19 Others

ANALYTICAL

1 BioAnalytical Methods, 2 Analytical Methods

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Filters

Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/03/2025	Neuland Laboratories	India	NEULAND LABORATORIES LTD	18892	LEVOFLOXACIN USP (HEMIHYDRATE)	2005-10-21	Active	II	Complete	2013-01-08	2012-12-13
28/03/2025	TAPI Technology & API Services	Israel	TEVA PHARMACEUTICAL INDUSTRIES LTD	16521	LEVOFLOXACIN	2003-04-07	Active	II	Complete	2012-11-30	2012-11-09

Levofloxacin

Levofloxacin

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

58 API Suppliers

27 USDMF

11 JDMF

7 EU WC

21 KDMF

23 NDC API

1 VMF

27 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

560 FDF Dossiers

119 FDA Orange Book

217 Europe

19 Canada

56 South Africa

149 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

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

24 BASF

1 Bioplus Life Sciences

1 Clariant

10 Corel Pharma Chem

6 DFE Pharma

4 Finar

11 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

30 Kerry

3 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

1 Nanjing Bold Chemical

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

12 Sigachi Industries

2 The Dow Chemical Company

2 Ulanqab Kema New Material

1 Valens Pharmachem

4 Vasa Pharmachem

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