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Also known as: 138199-71-0, Levofloxacin hydrate, 6gnt3y5lmf, Nofaxin, Quinsair, Volequin
Molecular Formula
C36H42F2N6O9
Molecular Weight
740.7  g/mol
InChI Key
SUIQUYDRLGGZOL-RCWTXCDDSA-N
FDA UNII
6GNT3Y5LMF

Levofloxacin Hemihydrate
The L-isomer of Ofloxacin.
Levofloxacin is a Quinolone Antimicrobial.
1 2D Structure

Levofloxacin Hemihydrate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.05,13]trideca-5(13),6,8,11-tetraene-11-carboxylic acid;hydrate
2.1.2 InChI
InChI=1S/2C18H20FN3O4.H2O/c2*1-10-9-26-17-14-11(16(23)12(18(24)25)8-22(10)14)7-13(19)15(17)21-5-3-20(2)4-6-21;/h2*7-8,10H,3-6,9H2,1-2H3,(H,24,25);1H2/t2*10-;/m00./s1
2.1.3 InChI Key
SUIQUYDRLGGZOL-RCWTXCDDSA-N
2.1.4 Canonical SMILES
CC1COC2=C3N1C=C(C(=O)C3=CC(=C2N4CCN(CC4)C)F)C(=O)O.CC1COC2=C3N1C=C(C(=O)C3=CC(=C2N4CCN(CC4)C)F)C(=O)O.O
2.1.5 Isomeric SMILES
C[C@H]1COC2=C3N1C=C(C(=O)C3=CC(=C2N4CCN(CC4)C)F)C(=O)O.C[C@H]1COC2=C3N1C=C(C(=O)C3=CC(=C2N4CCN(CC4)C)F)C(=O)O.O
2.2 Other Identifiers
2.2.1 UNII
6GNT3Y5LMF
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Anhydrous, Levofloxacin

2. Levaquin

3. Levofloxacin

4. Levofloxacin Anhydrous

5. Ofloxacin, (s)-isomer

6. Quixin

2.3.2 Depositor-Supplied Synonyms

1. 138199-71-0

2. Levofloxacin Hydrate

3. 6gnt3y5lmf

4. Nofaxin

5. Quinsair

6. Volequin

7. Levaquin (tn)

8. Ofloxacin, (s)-

9. Rwj-25213

10. (-)-(s)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7h-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid, Hemihydrate

11. 7h-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid, 9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-hydrate (2:1), (s)-

12. Levofloxacin [usan]

13. Dynaquin

14. Levofloxacin (as Hemihydrate)

15. (s)-9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7h-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic Acid Hemihydrate

16. Unii-6gnt3y5lmf

17. Rwj 25213

18. Tavanic Hydrate

19. Cravit Hydrate

20. Iquix Hydrate

21. Quixin Hydrate

22. Levaquin Hydrate

23. Mfcd07772024

24. Levofloxacin (usp)

25. Quixin (tn)

26. Lvfx

27. Iquix (tn)

28. (s)-(-)-ofloxacine

29. (2s)-7-fluoro-2-methyl-6-(4-methylpiperazin-1-yl)-10-oxo-4-oxa-1-azatricyclo[7.3.1.05,13]trideca-5(13),6,8,11-tetraene-11-carboxylic Acid;hydrate

30. Levofloxacin [vandf]

31. Levofloxacin [mart.]

32. (s)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7h-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid Hydrate (2:1)

33. (s)-9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-3,7-dihydro-2h-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic Acid Hydrate(2:1)

34. Levofloxacin Hydrate (jp17)

35. Levofloxacin [usp-rs]

36. Levofloxacin Hemihidrated

37. Schembl1650602

38. Dtxsid60160533

39. Levofloxacin [orange Book]

40. Levofloxacin Hydrate [jan]

41. Levofloxacin [usp Monograph]

42. Akos015896149

43. Ks-1077

44. Levofloxacin [usan:usp:inn:ban:jan]

45. Levofloxacin Hemihydrate [who-dd]

46. 7h-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid, 9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-, Hydrate (2:1), (s)-

47. D00588

48. Levofloxacin Hemihydrate [ep Monograph]

49. Ofloxacin S-(-)-form Hemihydrate [mi]

50. 199l710

51. A886273

52. Q47495791

53. Levofloxacin, United States Pharmacopeia (usp) Reference Standard

54. 3 Inverted Exclamation Mark ,5 Inverted Exclamation Mark -difluoro-4-propylbiphenyl

55. Levofloxacin Hemihydrate, Pharmaceutical Secondary Standard; Certified Reference Material

56. (s)-(-)-ofloxacine; Levofloxacine; (-)-(s)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7h-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid Hydrochloride; Levofloxacin Hemihydrate;(s)-9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-3,7-dihydro-2h-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic Acid Hemihydrate

57. (s)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7h-pyrido(1,2,3-de)-1,4-benzoxazine-6-carboxylic Acid Hemihydrate

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 740.7 g/mol
Molecular Formula C36H42F2N6O9
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count17
Rotatable Bond Count4
Exact Mass740.29813326 g/mol
Monoisotopic Mass740.29813326 g/mol
Topological Polar Surface Area148 Ų
Heavy Atom Count53
Formal Charge0
Complexity634
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Indication

Quinsair is indicated for the management of chronic pulmonary infections due to Pseudomonas aeruginosa in adult patients with cystic fibrosis.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.


Treatment of cystic fibrosis


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Bacterial Agents

Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)


Anti-Infective Agents, Urinary

Substances capable of killing agents causing urinary tract infections or of preventing them from spreading. (See all compounds classified as Anti-Infective Agents, Urinary.)


Topoisomerase II Inhibitors

Compounds that inhibit the activity of DNA TOPOISOMERASE II. Included in this category are a variety of ANTINEOPLASTIC AGENTS which target the eukaryotic form of topoisomerase II and ANTIBACTERIAL AGENTS which target the prokaryotic form of topoisomerase II. (See all compounds classified as Topoisomerase II Inhibitors.)


Cytochrome P-450 CYP1A2 Inhibitors

Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP1A2. (See all compounds classified as Cytochrome P-450 CYP1A2 Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
LEVOFLOXACIN
5.2.2 FDA UNII
6GNT3Y5LMF
5.2.3 Pharmacological Classes
Chemical Structure [CS] - Quinolones
5.3 ATC Code

J01MA12


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LEVOFLOXACIN HEMIHYDRATE IP\/USP.","address":"48, CHANDRA GUPTA ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"ZHEJIANG EAST ASIA PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GORANG INTERNATIONAL","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"27.5","totalValueFC":"55281.2","currency":"USD","unitRateINR":"2355","date":"07-May-2025","totalValueINR":"4709991.61","totalValueInUsd":"55281.2","indian_port":"JNPT","hs_no":"29349990","bill_no":"9925613","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"Coastal Industrial City, Pubagang T own, Sanmen County, Zhejiang, China ., ., China China","customerAddress":"48, CHANDRA GUPTA ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747161000,"product":"LEVOFLOXACIN HEMIHYDRATE IP\/USP LEVOFLOXACIN HEMIHYDRATE IP\/USP","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"ZHEJIANG EAST ASIA PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SUN PHARMACEUTICAL INDUSTRIES LTD","customerCountry":"INDIA","quantity":"1075.00","actualQuantity":"1075","unit":"KGS","unitRateFc":"27.8","totalValueFC":"29953.6","currency":"USD","unitRateINR":"2374","date":"14-May-2025","totalValueINR":"2552063.44","totalValueInUsd":"29953.6","indian_port":"JNPT","hs_no":"29419090","bill_no":"2048328","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"COASTAL INDUSTRIAL CITY PUBAGANG TO WN SANMEN COUNTY ZHEJIANG CHINA SDNF China","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747593000,"product":"LEVOFLOXACIN HEMIHYDRATE IP LEVOFLOXACIN HEMIHYDRATE IP","address":"ACME PLAZA, ANDHERI KURLA ROAD,","city":"MUMBAI, MAHARASHTRA.","supplier":"ZHEJIANG HENGDIAN APELOA IMPORT AND EXPORT CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"SUN PHARMACEUTICAL INDUSTRIES LTD","customerCountry":"INDIA","quantity":"525.00","actualQuantity":"525","unit":"KGS","unitRateFc":"27.8","totalValueFC":"14773.8","currency":"N\/A","unitRateINR":"2397.6","date":"19-May-2025","totalValueINR":"1258740","totalValueInUsd":"14773.8","indian_port":"JNPT","hs_no":"29419090","bill_no":"2146113","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"13F, T1, HENGDIAN CENTER NO 136 FUC HUN ROAD SHANGCHENG DISTRICT HANGZH OU Hangzhou, , China China","customerAddress":"ACME PLAZA, ANDHERI KURLA ROAD,"}]
03-Jan-2022
31-May-2025
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Listed Dossiers

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01

Ethypharm

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Flag France
Digital Content Digital Content

Regulatory Info :

Registration Country : France

Levofloxacin Hemihydrate

Brand Name :

Dosage Form : Solution for Infusion

Dosage Strength : 5MG/ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : France

Ethypharm

01

Ethypharm

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothEthypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.

Flag France
Digital Content Digital Content

Packaging :

Regulatory Info :

Levofloxacin Hemihydrate

Dosage : Solution for Infusion

Dosage Strength : 5MG/ML

Brand Name :

Approval Date :

Application Number :

Registration Country : France

Ethypharm

02

Bal Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

Flag India
Digital Content Digital Content

Regulatory Info : Generic

Registration Country : India

Levofloxacin Hemihydrate

Brand Name : Balvoflo

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : India

BalPharma

02

Bal Pharma

India
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothBal Pharma, leading manufacturer of niche & specialty API, Intermediates and Finished Formulations.

Flag India
Digital Content Digital Content

Packaging :

Regulatory Info : Generic

Levofloxacin Hemihydrate

Dosage : Tablet

Dosage Strength : 500MG

Brand Name : Balvoflo

Approval Date :

Application Number :

Registration Country : India

BalPharma

03

Bio Labs

Pakistan
The Aesthetic Show
Not Confirmed
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Bio Labs

Pakistan
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Brand Name : F-Oxacin

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging : 10's

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Pakistan

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03

Bio Labs

Pakistan
The Aesthetic Show
Not Confirmed
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Bio Labs

Pakistan
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Dosage : TABLET

Dosage Strength : 500MG

Brand Name : F-Oxacin

Approval Date :

Application Number :

Registration Country : Pakistan

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04

Bio Labs

Pakistan
The Aesthetic Show
Not Confirmed
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Bio Labs

Pakistan
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Brand Name : Levobio

Dosage Form : TABLET

Dosage Strength : 500MG

Packaging : as per requirement

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Pakistan

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04

Bio Labs

Pakistan
The Aesthetic Show
Not Confirmed
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Bio Labs

Pakistan
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Dosage : TABLET

Dosage Strength : 500MG

Brand Name : Levobio

Approval Date :

Application Number :

Registration Country : Pakistan

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05

Bio Labs

Pakistan
The Aesthetic Show
Not Confirmed
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Bio Labs

Pakistan
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Brand Name : Voflox

Dosage Form : CAPSULE

Dosage Strength : 500MG

Packaging : 1 x 10's

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Pakistan

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05

Bio Labs

Pakistan
The Aesthetic Show
Not Confirmed
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Bio Labs

Pakistan
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Dosage : CAPSULE

Dosage Strength : 500MG

Brand Name : Voflox

Approval Date :

Application Number :

Registration Country : Pakistan

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06

Cuckos

India
The Aesthetic Show
Not Confirmed
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Cuckos

India
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Brand Name : Levofloxacin Hemihydra...

Dosage Form : Injection

Dosage Strength : 100MG/ML

Packaging : 50 mL, 100 mL

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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06

Cuckos

India
The Aesthetic Show
Not Confirmed
arrow

Cuckos

India
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Dosage : Injection

Dosage Strength : 100MG/ML

Brand Name : Levofloxacin Hemihydra...

Approval Date :

Application Number :

Registration Country : India

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07

MS Pharma

Jordan
The Aesthetic Show
Not Confirmed
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MS Pharma

Jordan
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Brand Name :

Dosage Form : TABLET

Dosage Strength : 250MG

Packaging : Pack Size in UPM - 7

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : Jordan

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07

MS Pharma

Jordan
The Aesthetic Show
Not Confirmed
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MS Pharma

Jordan
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Dosage : TABLET

Dosage Strength : 250MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Jordan

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08

The Aesthetic Show
Not Confirmed
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The Aesthetic Show
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Levofloxacin Hemihydrate

Brand Name : Levoxine

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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08

The Aesthetic Show
Not Confirmed
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The Aesthetic Show
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Levofloxacin Hemihydrate

Dosage : Tablet

Dosage Strength : 500MG

Brand Name : Levoxine

Approval Date :

Application Number :

Registration Country : India

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09

Neopharma

U.A.E
The Aesthetic Show
Not Confirmed
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Neopharma

U.A.E
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Brand Name : Levanix

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging : 1X5's, 1X7's

Approval Date :

Application Number :

Regulatory Info :

Registration Country : U.A.E

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09

Neopharma

U.A.E
The Aesthetic Show
Not Confirmed
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Neopharma

U.A.E
arrow
The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Dosage : Tablet

Dosage Strength : 500MG

Brand Name : Levanix

Approval Date :

Application Number :

Registration Country : U.A.E

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10

The Aesthetic Show
Not Confirmed
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The Aesthetic Show
Not Confirmed

Levofloxacin Hemihydrate

Brand Name :

Dosage Form : Tablet

Dosage Strength : 500MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : India

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10

The Aesthetic Show
Not Confirmed
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The Aesthetic Show
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Levofloxacin Hemihydrate

Dosage : Tablet

Dosage Strength : 500MG

Brand Name :

Approval Date :

Application Number :

Registration Country : India

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ABOUT THIS PAGE

Looking for 138199-71-0 / Levofloxacin Hemihydrate API manufacturers, exporters & distributors?

Levofloxacin Hemihydrate manufacturers, exporters & distributors 1

42

PharmaCompass offers a list of Levofloxacin Hemihydrate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Levofloxacin Hemihydrate manufacturer or Levofloxacin Hemihydrate supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Levofloxacin Hemihydrate manufacturer or Levofloxacin Hemihydrate supplier.

PharmaCompass also assists you with knowing the Levofloxacin Hemihydrate API Price utilized in the formulation of products. Levofloxacin Hemihydrate API Price is not always fixed or binding as the Levofloxacin Hemihydrate Price is obtained through a variety of data sources. The Levofloxacin Hemihydrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Levofloxacin Hemihydrate

Synonyms

138199-71-0, Levofloxacin hydrate, 6gnt3y5lmf, Nofaxin, Quinsair, Volequin

Cas Number

138199-71-0

Unique Ingredient Identifier (UNII)

6GNT3Y5LMF

About Levofloxacin Hemihydrate

The L-isomer of Ofloxacin.

Levofloxacin Hemihydrate Manufacturers

A Levofloxacin Hemihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levofloxacin Hemihydrate, including repackagers and relabelers. The FDA regulates Levofloxacin Hemihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levofloxacin Hemihydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Levofloxacin Hemihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Levofloxacin Hemihydrate Suppliers

A Levofloxacin Hemihydrate supplier is an individual or a company that provides Levofloxacin Hemihydrate active pharmaceutical ingredient (API) or Levofloxacin Hemihydrate finished formulations upon request. The Levofloxacin Hemihydrate suppliers may include Levofloxacin Hemihydrate API manufacturers, exporters, distributors and traders.

click here to find a list of Levofloxacin Hemihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Levofloxacin Hemihydrate USDMF

A Levofloxacin Hemihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Levofloxacin Hemihydrate active pharmaceutical ingredient (API) in detail. Different forms of Levofloxacin Hemihydrate DMFs exist exist since differing nations have different regulations, such as Levofloxacin Hemihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Levofloxacin Hemihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. Levofloxacin Hemihydrate USDMF includes data on Levofloxacin Hemihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Levofloxacin Hemihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Levofloxacin Hemihydrate suppliers with USDMF on PharmaCompass.

Levofloxacin Hemihydrate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Levofloxacin Hemihydrate Drug Master File in Japan (Levofloxacin Hemihydrate JDMF) empowers Levofloxacin Hemihydrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Levofloxacin Hemihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Levofloxacin Hemihydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Levofloxacin Hemihydrate suppliers with JDMF on PharmaCompass.

Levofloxacin Hemihydrate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Levofloxacin Hemihydrate Drug Master File in Korea (Levofloxacin Hemihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Levofloxacin Hemihydrate. The MFDS reviews the Levofloxacin Hemihydrate KDMF as part of the drug registration process and uses the information provided in the Levofloxacin Hemihydrate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Levofloxacin Hemihydrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Levofloxacin Hemihydrate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Levofloxacin Hemihydrate suppliers with KDMF on PharmaCompass.

Levofloxacin Hemihydrate CEP

A Levofloxacin Hemihydrate CEP of the European Pharmacopoeia monograph is often referred to as a Levofloxacin Hemihydrate Certificate of Suitability (COS). The purpose of a Levofloxacin Hemihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Levofloxacin Hemihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Levofloxacin Hemihydrate to their clients by showing that a Levofloxacin Hemihydrate CEP has been issued for it. The manufacturer submits a Levofloxacin Hemihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Levofloxacin Hemihydrate CEP holder for the record. Additionally, the data presented in the Levofloxacin Hemihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Levofloxacin Hemihydrate DMF.

A Levofloxacin Hemihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Levofloxacin Hemihydrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Levofloxacin Hemihydrate suppliers with CEP (COS) on PharmaCompass.

Levofloxacin Hemihydrate WC

A Levofloxacin Hemihydrate written confirmation (Levofloxacin Hemihydrate WC) is an official document issued by a regulatory agency to a Levofloxacin Hemihydrate manufacturer, verifying that the manufacturing facility of a Levofloxacin Hemihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Levofloxacin Hemihydrate APIs or Levofloxacin Hemihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Levofloxacin Hemihydrate WC (written confirmation) as part of the regulatory process.

click here to find a list of Levofloxacin Hemihydrate suppliers with Written Confirmation (WC) on PharmaCompass.

Levofloxacin Hemihydrate GMP

Levofloxacin Hemihydrate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Levofloxacin Hemihydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Levofloxacin Hemihydrate GMP manufacturer or Levofloxacin Hemihydrate GMP API supplier for your needs.

Levofloxacin Hemihydrate CoA

A Levofloxacin Hemihydrate CoA (Certificate of Analysis) is a formal document that attests to Levofloxacin Hemihydrate's compliance with Levofloxacin Hemihydrate specifications and serves as a tool for batch-level quality control.

Levofloxacin Hemihydrate CoA mostly includes findings from lab analyses of a specific batch. For each Levofloxacin Hemihydrate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Levofloxacin Hemihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Levofloxacin Hemihydrate EP), Levofloxacin Hemihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Levofloxacin Hemihydrate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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