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47 RELATED EXCIPIENT COMPANIES

85EXCIPIENTS BY APPLICATIONS

Chemistry

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Also known as: 352458-37-8, Delafloxacin (meglumine), Rx-3341 meglumine, Wq-3034 meglumine, Delafloxacin meglumine [usan], N7v53u4u4t
Molecular Formula
C25H29ClF3N5O9
Molecular Weight
636.0  g/mol
InChI Key
AHJGUEMIZPMAMR-WZTVWXICSA-N
FDA UNII
N7V53U4U4T

Delafloxacin Meglumine
1 2D Structure

Delafloxacin Meglumine

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-7-(3-hydroxyazetidin-1-yl)-4-oxoquinoline-3-carboxylic acid;(2R,3R,4R,5S)-6-(methylamino)hexane-1,2,3,4,5-pentol
2.1.2 InChI
InChI=1S/C18H12ClF3N4O4.C7H17NO5/c19-12-13-7(1-9(20)14(12)25-3-6(27)4-25)15(28)8(18(29)30)5-26(13)17-11(22)2-10(21)16(23)24-17;1-8-2-4(10)6(12)7(13)5(11)3-9/h1-2,5-6,27H,3-4H2,(H2,23,24)(H,29,30);4-13H,2-3H2,1H3/t;4-,5+,6+,7+/m.0/s1
2.1.3 InChI Key
AHJGUEMIZPMAMR-WZTVWXICSA-N
2.1.4 Canonical SMILES
CNCC(C(C(C(CO)O)O)O)O.C1C(CN1C2=C(C=C3C(=C2Cl)N(C=C(C3=O)C(=O)O)C4=C(C=C(C(=N4)N)F)F)F)O
2.1.5 Isomeric SMILES
CNC[C@@H]([C@H]([C@@H]([C@@H](CO)O)O)O)O.C1C(CN1C2=C(C=C3C(=C2Cl)N(C=C(C3=O)C(=O)O)C4=C(C=C(C(=N4)N)F)F)F)O
2.2 Other Identifiers
2.2.1 UNII
N7V53U4U4T
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 352458-37-8

2. Delafloxacin (meglumine)

3. Rx-3341 Meglumine

4. Wq-3034 Meglumine

5. Delafloxacin Meglumine [usan]

6. N7v53u4u4t

7. Abt-492 Meglumine

8. Unii-n7v53u4u4t

9. 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-7-(3-hydroxyazetidin-1-yl)-4-oxoquinoline-3-carboxylic Acid;(2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentol

10. Delafloxacin Meglumine (usan)

11. 1-deoxy-1-(methylamino)-d-glucitol 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-7-(3-hydroxyazetidin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylate (salt)

12. D-glucitol, 1-deoxy-1-(methylamino)-, 1-(6-amino-3,5-difluoro-2-pyridinyl)-8-chloro-6-fluoro-1,4-dihydro-7-(3-hydroxy-1-azetidinyl)-4-oxo-3-quinolinecarboxylate (salt)

13. Baxdela (tn)

14. Abt492 Meglumine

15. Schembl300983

16. Chembl2105638

17. Dtxsid90188740

18. Delafloxacin Meglumine [mi]

19. (2r,3r,4r,5s)-2,3,4,5-tetrahydroxy-6-(methylamino)hexyl 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-7-(3-hydroxyazetidin-1-yl)-4-oxo-1,4-dihydroquin

20. Ex-a3992

21. Hy-14814a

22. S4488

23. Wq-3034 And Abt-492

24. Akos025404885

25. Cs-1479

26. Delafloxacin Meglumine [who-dd]

27. Ac-36496

28. Bs-16614

29. Delafloxacin Meglumine [orange Book]

30. Abt-492;rx-3341;wq-3034;baxdela

31. D09331

32. D70784

33. A874684

34. Q27284685

35. Delafloxacin Meglumine (abt492 Meglumine; Rx-3341 Meglumine; Wq-3034 Meglumine)

36. (2r,3r,4r,5s)-6-(methylamino)hexane-1,2,3,4,5-pentaol 1-(6-amino-3,5-difluoropyridin-2-yl)-8-chloro-6-fluoro-7-(3-hydroxyazetidin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylate

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 636.0 g/mol
Molecular Formula C25H29ClF3N5O9
Hydrogen Bond Donor Count9
Hydrogen Bond Acceptor Count17
Rotatable Bond Count9
Exact Mass635.1605897 g/mol
Monoisotopic Mass635.1605897 g/mol
Topological Polar Surface Area233 Ų
Heavy Atom Count43
Formal Charge0
Complexity889
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 1  
Drug NameBAXDELA
Active IngredientDELAFLOXACIN MEGLUMINE
CompanyMELINTA THERAPS INC (Application Number: N208610); MELINTA THERAPS INC (Application Number: N208611)

5 Pharmacology and Biochemistry
5.1 FDA Pharmacological Classification
5.1.1 Pharmacological Classes
Fluoroquinolones [CS]; Fluoroquinolone Antibacterial [EPC]

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[{"dataSource":"API Export","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1707762600,"product":"PHARMACEUTICAL ALLOPATHIC RAW MATERIAL OF PHARMACEUTICAL GRADE DELAFLOXACIN MEGLUMINE","address":"VILL. BHONDSI, TECH, SOHNA,","city":"GURGAON","supplier":"KIMIA BIOSCIENCES","supplierCountry":"INDIA","foreign_port":"CAIRO","customer":"TO THE ORDER","customerCountry":"EGYPT","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"3250","totalValueFC":"519.1","currency":"USD","unitRateINR":215364,"date":"13-Feb-2024","totalValueINR":"43072.8","totalValueInUsd":"519.1","indian_port":"Delhi Air","hs_no":"29333929","bill_no":"7478073","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"Delhi Air","supplierAddress":"VILL. BHONDSI, TECH, SOHNA,, GURGAON","customerAddress":""}]
13-Feb-2024
13-Feb-2024
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ABOUT THIS PAGE

Delafloxacin Meglumine Manufacturers

A Delafloxacin Meglumine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Delafloxacin Meglumine, including repackagers and relabelers. The FDA regulates Delafloxacin Meglumine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Delafloxacin Meglumine 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 Delafloxacin Meglumine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Delafloxacin Meglumine Suppliers

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

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

Delafloxacin Meglumine NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Delafloxacin Meglumine as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Delafloxacin Meglumine API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Delafloxacin Meglumine as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Delafloxacin Meglumine and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Delafloxacin Meglumine NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Delafloxacin Meglumine suppliers with NDC on PharmaCompass.

Delafloxacin Meglumine GMP

Delafloxacin Meglumine 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 Delafloxacin Meglumine 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 Delafloxacin Meglumine GMP manufacturer or Delafloxacin Meglumine GMP API supplier for your needs.

Delafloxacin Meglumine CoA

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

Delafloxacin Meglumine CoA mostly includes findings from lab analyses of a specific batch. For each Delafloxacin Meglumine 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.

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