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Chemistry

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Also known as: 186826-86-8, Moxifloxacin hcl, Avelox, Avalox, Vigamox, Moxifloxacin (hydrochloride)
Molecular Formula
C21H25ClFN3O4
Molecular Weight
437.9  g/mol
InChI Key
IDIIJJHBXUESQI-DFIJPDEKSA-N
FDA UNII
C53598599T

Moxifloxacin Hydrochloride
A fluoroquinolone that acts as an inhibitor of DNA TOPOISOMERASE II and is used as a broad-spectrum antibacterial agent.
1 2D Structure

Moxifloxacin Hydrochloride

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
7-[(4aS,7aS)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic acid;hydrochloride
2.1.2 InChI
InChI=1S/C21H24FN3O4.ClH/c1-29-20-17-13(19(26)14(21(27)28)9-25(17)12-4-5-12)7-15(22)18(20)24-8-11-3-2-6-23-16(11)10-24;/h7,9,11-12,16,23H,2-6,8,10H2,1H3,(H,27,28);1H/t11-,16+;/m0./s1
2.1.3 InChI Key
IDIIJJHBXUESQI-DFIJPDEKSA-N
2.1.4 Canonical SMILES
COC1=C2C(=CC(=C1N3CC4CCCNC4C3)F)C(=O)C(=CN2C5CC5)C(=O)O.Cl
2.1.5 Isomeric SMILES
COC1=C2C(=CC(=C1N3C[C@@H]4CCCN[C@@H]4C3)F)C(=O)C(=CN2C5CC5)C(=O)O.Cl
2.2 Other Identifiers
2.2.1 UNII
C53598599T
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 1-cyclopropyl--7-(2,8-diazabicyclo(4.3.0)non-8-yl)-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3-quinolinecarboxylic Acid

2. Actira

3. Avalox

4. Avelox

5. Bay 12 8039

6. Bay 12-8039

7. Bay 128039

8. Bay-12-8039

9. Bay-128039

10. Bay128039

11. Izilox

12. Moxifloxacin

13. Octegra

14. Proflox

2.3.2 Depositor-Supplied Synonyms

1. 186826-86-8

2. Moxifloxacin Hcl

3. Avelox

4. Avalox

5. Vigamox

6. Moxifloxacin (hydrochloride)

7. Bay 12-8039

8. Bay-12-8039

9. Actira

10. Izilox

11. Moxifloxacine Hydrochloride

12. Chebi:7008

13. Moxifloxacin (as Hydrochloride)

14. Bay12-8039 Hcl

15. Moxeza

16. Al-15469a

17. Nsc-758875

18. (4as-cis)-1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-(octahydro-6h-pyrrolol(3,4-b)pyridin-6-yl)-4-oxo-3-quinolinecarboxylic Acid, Monohydrochloride

19. 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-((4as,7as)-octahydro-6h-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-3-quinolinecarboxylic Acid, Monohydrochloride

20. C53598599t

21. Bay-128039

22. Dsstox_cid_25921

23. Dsstox_rid_81224

24. Dsstox_gsid_45921

25. 7-[(4as,7as)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic Acid Hydrochloride

26. 7-[(4as,7as)-octahydro-1h-pyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

27. 186826-86-8 (hcl); 354812-41-2 (free Base)

28. Octegra

29. Vigamox (tn)

30. Avelox (tn)

31. Mflx

32. 1-cyclopropyl-6-fluoro-7-((4as,7as)-hexahydro-1h-pyrrolo[3,4-b]pyridin-6(2h)-yl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

33. 1-cyclopropyl-6-fluoro-8-methoxy-4-oxo-7-((4as,7as)-tetrahydro-1h-pyrrolo[3,4-b]pyridin-6(2h,7h,7ah)-yl)-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

34. 7-[(4as,7as)-1,2,3,4,4a,5,7,7a-octahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic Acid;hydrochloride

35. Cas-186826-86-8

36. Moxifloxacin Hydrochloride [usan]

37. Moxivig

38. Vegamox

39. Actura

40. Moxifloxacin, Hcl

41. Unii-c53598599t

42. Ncgc00095130-01

43. 1-cyclopropyl-6-fluoro-8-methoxy-7-((4as,7as)-octahydro-6h-pyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

44. 1-cyclopropyl-6-fluoro-8-methoxy-7-[(4as,7as)-octahydro-6h-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

45. Mfcd00949117

46. Bay12-8039

47. Moxifloxacin Hydrochloride [usan:usp]

48. Avelox In Sodium Chloride 0.8% In Plastic Container

49. Cpd000469185

50. 1-cyclopropyl-6-fluoro-8-methoxy-7-((4as,7as)-octahydropyrrolo[3,4-b]pyridin-6-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride

51. Schembl37285

52. Mls001401368

53. Chembl1200735

54. Dtxsid4045921

55. Moxifloxacin Hcl [vandf]

56. Act02692

57. Amy25227

58. Bcp03623

59. Tox21_111439

60. Moxifloxacin Hydrochloride (jan/usp)

61. Akos015920132

62. Akos016015225

63. Tox21_111439_1

64. Ac-1275

65. Bcp9000963

66. Ccg-100924

67. Cs-1063

68. Ks-1181

69. Moxifloxacin Hydrochloride [mi]

70. Nc00174

71. Nsc 758875

72. Moxifloxacin Hydrochloride [jan]

73. Ncgc00271749-02

74. 3-quinolinecarboxylic Acid, 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-((4as,7as)-octahydro-6h-pyrrolo(3,4-b)pyridin-6-yl)-4-oxo-, Monohydrochloride

75. Hy-66011

76. Moxifloxacin Hydrochloride [mart.]

77. Smr000469185

78. Bcp0726000173

79. Moxifloxacin Hydrochloride [usp-rs]

80. Moxifloxacin Hydrochloride [who-dd]

81. Moxifloxacin Hydrochloride, >=98% (hplc)

82. M2479

83. S1465

84. Sw197554-3

85. D00874

86. Moxifloxacin Hydrochloride [orange Book]

87. Moxifloxacin Hydrochloride [ep Monograph]

88. 826m868

89. Moxifloxacin Hydrochloride [usp Monograph]

90. Q27107395

91. 186826-86-8 151096-09-2(base)

92. Moxifloxacin Hydrochloride, Vetranal(tm), Analytical Standard

93. Moxifloxacin Hydrochloride, European Pharmacopoeia (ep) Reference Standard

94. Moxifloxacin For Peak Identification, European Pharmacopoeia (ep) Reference Standard

95. Moxifloxacin Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material

96. Moxifloxacin Hydrochloride, United States Pharmacopeia (usp) Reference Standard

97. 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4as,7as)-octahydro-1h-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid Hydrochloride

98. 1-cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4as,7as)-octahydro-6h-pyrrolo[3,4-b]pyridin-6-yl]-4-oxo-3-quinolinecarboxylic Acid Hydrochloride (1:1)

99. 1-cyclopropyl-6-fluoro-7-((4as,7as)-hexahydro-1h-pyrrolo[3,4-b]pyridin-6(2h)-yl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hcl

100. 1-cyclopropyl-6-fluoro-7-((4as,7as)-hexahydro-1h-pyrrolo[3,4-b]pyridin-6(2h)-yl)-8-methoxy-4-oxo-1,4-dihydroquinoline-3-carboxylicacidhydrochloride

101. 7-[[(4as,8as)-2,3,4,4a,5,6,8,8a-octahydro-1h-1,7-naphthyridin-7-yl]methyl]-1-cyclopropyl-6-fluoro-8-methoxy-4-oxoquinoline-3-carboxylic Acid;hydrochloride

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 437.9 g/mol
Molecular Formula C21H25ClFN3O4
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count8
Rotatable Bond Count4
Exact Mass437.1517621 g/mol
Monoisotopic Mass437.1517621 g/mol
Topological Polar Surface Area82.1 Ų
Heavy Atom Count30
Formal Charge0
Complexity727
Isotope Atom Count0
Defined Atom Stereocenter Count2
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 8  
Drug NameAvelox
Drug LabelDESCRIPTIONAVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is availab...
Active IngredientMoxifloxacin hydrochloride
Dosage FormTablet
Routeoral; Oral
Strengtheq 400mg base; 400mg
Market StatusPrescription
CompanyBayer Pharms; Bayer Hlthcare

2 of 8  
Drug NameMoxeza
PubMed HealthMoxifloxacin
Drug ClassesAntibiotic
Drug LabelMOXEZA is a sterile solution for topical ophthalmic use.Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. C21H24FN3O4HClMol Wt 437.9...
Active IngredientMoxifloxacin hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.5% base
Market StatusPrescription
CompanyAlcon Pharms

3 of 8  
Drug NameMoxifloxacin hydrochloride
PubMed HealthMoxifloxacin
Drug ClassesAntibiotic
Drug LabelDESCRIPTIONAVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is availab...
Active IngredientMoxifloxacin hydrochloride
Dosage FormSolution/drops; Tablet; Solution
RouteOphthalmic; Oral; ophthalmic
Strength0.5%; eq 0.5% base; eq 400mg base
Market StatusTentative Approval; Prescription
CompanyApotex; Aurobindo Pharma; Teva Pharms Usa; Torrent Pharms; Lupin; Teva Pharms; Dr Reddys Labs

4 of 8  
Drug NameVigamox
PubMed HealthMoxifloxacin
Drug ClassesAntibiotic
Drug LabelVIGAMOX (moxifloxacin HCl ophthalmic solution) 0.5% is a sterile ophthalmic solution. It is an 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use.Chemical Name:1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-...
Active IngredientMoxifloxacin hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.5% base
Market StatusPrescription
CompanyAlcon Pharms

5 of 8  
Drug NameAvelox
Drug LabelDESCRIPTIONAVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is availab...
Active IngredientMoxifloxacin hydrochloride
Dosage FormTablet
Routeoral; Oral
Strengtheq 400mg base; 400mg
Market StatusPrescription
CompanyBayer Pharms; Bayer Hlthcare

6 of 8  
Drug NameMoxeza
PubMed HealthMoxifloxacin
Drug ClassesAntibiotic
Drug LabelMOXEZA is a sterile solution for topical ophthalmic use.Moxifloxacin hydrochloride is an 8-methoxy fluoroquinolone anti-infective, with a diazabicyclononyl ring at the C7 position. C21H24FN3O4HClMol Wt 437.9...
Active IngredientMoxifloxacin hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.5% base
Market StatusPrescription
CompanyAlcon Pharms

7 of 8  
Drug NameMoxifloxacin hydrochloride
PubMed HealthMoxifloxacin
Drug ClassesAntibiotic
Drug LabelDESCRIPTIONAVELOX (moxifloxacin hydrochloride) is a synthetic broad spectrum antibacterial agent and is available as AVELOX Tablets for oral administration and as AVELOX I.V. for intravenous administration. Moxifloxacin, a fluoroquinolone, is availab...
Active IngredientMoxifloxacin hydrochloride
Dosage FormSolution/drops; Tablet; Solution
RouteOphthalmic; Oral; ophthalmic
Strength0.5%; eq 0.5% base; eq 400mg base
Market StatusTentative Approval; Prescription
CompanyApotex; Aurobindo Pharma; Teva Pharms Usa; Torrent Pharms; Lupin; Teva Pharms; Dr Reddys Labs

8 of 8  
Drug NameVigamox
PubMed HealthMoxifloxacin
Drug ClassesAntibiotic
Drug LabelVIGAMOX (moxifloxacin HCl ophthalmic solution) 0.5% is a sterile ophthalmic solution. It is an 8-methoxy fluoroquinolone anti-infective for topical ophthalmic use.Chemical Name:1-Cyclopropyl-6-fluoro-1,4-dihydro-8-methoxy-7-[(4aS,7aS)-octahydro-6H-...
Active IngredientMoxifloxacin hydrochloride
Dosage FormSolution/drops
RouteOphthalmic
Strengtheq 0.5% base
Market StatusPrescription
CompanyAlcon Pharms

4.2 Drug Indication

Acute Exacerbation of Chronic Bronchitis, Community Acquired Pneumonia, Complicated Intra-Abdominal Infection, Complicated Skin and Skin Structure Infections, Pelvic Inflammatory Disease, Treatment of acute bacterial sinusitis


Acute Exacerbation of Chronic Bronchitis, Community Acquired Pneumonia, Complicated Intra-Abdominal Infection, Complicated Skin and Skin Structure Infections, Pelvic Inflammatory Disease, Treatment of acute bacterial sinusitis


Acute Exacerbation of Chronic Bronchitis, Community Acquired Pneumonia, Complicated Intra-Abdominal Infection, Complicated Skin and Skin Structure Infections, Pelvic Inflammatory Disease, Treatment of acute bacterial sinusitis


Acute Exacerbation of Chronic Bronchitis, Community Acquired Pneumonia, Complicated Intra-Abdominal Infection, Complicated Skin and Skin Structure Infections, Pelvic Inflammatory Disease, Treatment of acute bacterial sinusitis


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


Anti-Bacterial Agents

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


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Quinolones [CS]; Quinolone Antimicrobial [EPC]

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10-Jan-2022
28-May-2025
KGS
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DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21085

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DOSAGE - SOLUTION;INTRAVENOUS - 400MG/250ML (...DOSAGE - SOLUTION;INTRAVENOUS - 400MG/250ML (1.6MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21277

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DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE

USFDA APPLICATION NUMBER - 21598

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ABOUT THIS PAGE

Looking for 186826-86-8 / Moxifloxacin Hydrochloride API manufacturers, exporters & distributors?

Moxifloxacin Hydrochloride manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Moxifloxacin Hydrochloride 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 Moxifloxacin Hydrochloride manufacturer or Moxifloxacin Hydrochloride supplier for your needs.

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

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

API | Excipient name

Moxifloxacin Hydrochloride

Synonyms

186826-86-8, Moxifloxacin hcl, Avelox, Avalox, Vigamox, Moxifloxacin (hydrochloride)

Cas Number

186826-86-8

Unique Ingredient Identifier (UNII)

C53598599T

About Moxifloxacin Hydrochloride

A fluoroquinolone that acts as an inhibitor of DNA TOPOISOMERASE II and is used as a broad-spectrum antibacterial agent.

Moxifloxacin Hydrochloride Monohydrate Manufacturers

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

Moxifloxacin Hydrochloride Monohydrate Suppliers

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

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

Moxifloxacin Hydrochloride Monohydrate USDMF

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

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

click here to find a list of Moxifloxacin Hydrochloride Monohydrate suppliers with USDMF on PharmaCompass.

Moxifloxacin Hydrochloride Monohydrate 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 Moxifloxacin Hydrochloride Monohydrate Drug Master File in Japan (Moxifloxacin Hydrochloride Monohydrate JDMF) empowers Moxifloxacin Hydrochloride Monohydrate 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 Moxifloxacin Hydrochloride Monohydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Moxifloxacin Hydrochloride Monohydrate 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 Moxifloxacin Hydrochloride Monohydrate suppliers with JDMF on PharmaCompass.

Moxifloxacin Hydrochloride Monohydrate KDMF

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

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

After submitting a Moxifloxacin Hydrochloride Monohydrate 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 Moxifloxacin Hydrochloride Monohydrate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Moxifloxacin Hydrochloride Monohydrate suppliers with KDMF on PharmaCompass.

Moxifloxacin Hydrochloride Monohydrate CEP

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

A Moxifloxacin Hydrochloride Monohydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Moxifloxacin Hydrochloride Monohydrate 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 Moxifloxacin Hydrochloride Monohydrate suppliers with CEP (COS) on PharmaCompass.

Moxifloxacin Hydrochloride Monohydrate WC

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

click here to find a list of Moxifloxacin Hydrochloride Monohydrate suppliers with Written Confirmation (WC) on PharmaCompass.

Moxifloxacin Hydrochloride Monohydrate 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 Moxifloxacin Hydrochloride Monohydrate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Moxifloxacin Hydrochloride Monohydrate 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 Moxifloxacin Hydrochloride Monohydrate 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 Moxifloxacin Hydrochloride Monohydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Moxifloxacin Hydrochloride Monohydrate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Moxifloxacin Hydrochloride Monohydrate suppliers with NDC on PharmaCompass.

Moxifloxacin Hydrochloride Monohydrate GMP

Moxifloxacin Hydrochloride Monohydrate 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 Moxifloxacin Hydrochloride Monohydrate 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 Moxifloxacin Hydrochloride Monohydrate GMP manufacturer or Moxifloxacin Hydrochloride Monohydrate GMP API supplier for your needs.

Moxifloxacin Hydrochloride Monohydrate CoA

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

Moxifloxacin Hydrochloride Monohydrate CoA mostly includes findings from lab analyses of a specific batch. For each Moxifloxacin Hydrochloride Monohydrate 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.

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