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Levaquin

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ACTIVE PHARMA INGREDIENTS

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

DEVELOPMENTS

3 Drugs in Development

3 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

548 FDF Dossiers, 119 FDA Orange Book, 217 Europe, 19 Canada, 56 South Africa, 137 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TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION/DROPS;OPHTHALMIC - 1.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 250MG/10ML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 Rochem International Inc, 4 SPI Pharma, 2 Seqens, 5 DKSH, 2 Jai Radhe Sales, 1 Pharm-RX Chemical, 6 Faran Shimi Pharmaceutical, 9 Boai NKY Pharmaceuticals Ltd, 14 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

73 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 40 Disintegrants & Superdisintegrants, 37 Direct Compression, 30 Solubilizers, 28 Controlled & Modified Release, 27 Thickeners and Stabilizers, 24 Granulation, 24 Parenteral, 18 Topical, 18 Co-Processed Excipients, 16 Lubricants & Glidants, 15 Film Formers & Plasticizers, 13 Taste Masking, 9 Chewable & Orodispersible Aids, 8 Emulsifying Agents, 6 API Stability Enhancers, 5 Coloring Agents, 5 Rheology Modifiers, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 48 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

221 Finished Drug Prices, 1 Annual Reports

MARKET PLACE

29 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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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Neuland Laboratories	India	NEULAND LABORATORIES LTD	18892	LEVOFLOXACIN USP (HEMIHYDRATE)	2005-10-21	Active	II	Complete	2013-01-08	2012-12-13
28/10/2024	Apotex Pharmachem	Canada	APOTEX PHARMACHEM INDIA PVT LTD	19458	LEVOFLOXACIN USP	2006-05-19	Active	II	N/A

Levaquin

Levaquin

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

59 API Suppliers

27 USDMF

11 JDMF

7 EU WC

21 KDMF

23 NDC API

27 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

3 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

548 FDF Dossiers

119 FDA Orange Book

217 Europe

19 Canada

56 South Africa

137 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 Rochem International Inc

4 SPI Pharma

2 Seqens

5 DKSH

2 Jai Radhe Sales

1 Pharm-RX Chemical

6 Faran Shimi Pharmaceutical

9 Boai NKY Pharmaceuticals Ltd

14 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