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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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01-Jan-2022
31-May-2025
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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

13

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.

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER Manufacturers

A AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, including repackagers and relabelers. The FDA regulates AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER Suppliers

A AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER supplier is an individual or a company that provides AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER active pharmaceutical ingredient (API) or AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER finished formulations upon request. The AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER suppliers may include AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER API manufacturers, exporters, distributors and traders.

click here to find a list of AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER USDMF

A AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER DMF (Drug Master File) is a document detailing the whole manufacturing process of AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER active pharmaceutical ingredient (API) in detail. Different forms of AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER DMFs exist exist since differing nations have different regulations, such as AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER DMF submitted to regulatory agencies in the US is known as a USDMF. AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER USDMF includes data on AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER USDMF is kept confidential to protect the manufacturer’s intellectual property.

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AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER Drug Master File in Japan (AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER JDMF) empowers AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER JDMF during the approval evaluation for pharmaceutical products. At the time of AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER KDMF

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

Pharmaceutical companies submit a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER Drug Master File in Korea (AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER. The MFDS reviews the AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER KDMF as part of the drug registration process and uses the information provided in the AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER KDMF to evaluate the safety and efficacy of the drug.

After submitting a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER API can apply through the Korea Drug Master File (KDMF).

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AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CEP

A AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CEP of the European Pharmacopoeia monograph is often referred to as a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER Certificate of Suitability (COS). The purpose of a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER to their clients by showing that a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CEP has been issued for it. The manufacturer submits a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CEP (COS) as part of the market authorization procedure, and it takes on the role of a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CEP holder for the record. Additionally, the data presented in the AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER DMF.

A AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

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AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER WC

A AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER written confirmation (AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER WC) is an official document issued by a regulatory agency to a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER manufacturer, verifying that the manufacturing facility of a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER APIs or AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER finished pharmaceutical products to another nation, regulatory agencies frequently require a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER WC (written confirmation) as part of the regulatory process.

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AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER NDC to their finished compounded human drug products, they may choose to do so.

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AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER GMP

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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 AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER GMP manufacturer or AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER GMP API supplier for your needs.

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CoA

A AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CoA (Certificate of Analysis) is a formal document that attests to AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER's compliance with AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER specifications and serves as a tool for batch-level quality control.

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER CoA mostly includes findings from lab analyses of a specific batch. For each AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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.

AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER may be tested according to a variety of international standards, such as European Pharmacopoeia (AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER EP), AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER JP (Japanese Pharmacopeia) and the US Pharmacopoeia (AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER 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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