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1. Anhydrous, Levofloxacin
2. Levaquin
3. Levofloxacin
4. Levofloxacin Anhydrous
5. Ofloxacin, (s)-isomer
6. Quixin
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
| Molecular Weight | 740.7 g/mol |
|---|---|
| Molecular Formula | C36H42F2N6O9 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 17 |
| Rotatable Bond Count | 4 |
| Exact Mass | 740.29813326 g/mol |
| Monoisotopic Mass | 740.29813326 g/mol |
| Topological Polar Surface Area | 148 Ų |
| Heavy Atom Count | 53 |
| Formal Charge | 0 |
| Complexity | 634 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 3 |
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
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.)
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GDUFA
DMF Review : Complete
Rev. Date : 2020-08-14
Pay. Date : 2020-08-10
DMF Number : 16658
Submission : 2003-06-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32663
Submission : 2018-03-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39212
Submission : 2023-12-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33244
Submission : 2018-10-16
Status : Active
Type : II
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ABOUT THIS PAGE
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.
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.
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.
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.
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.
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.
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 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.
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).
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