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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]

    API Reference Price

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PART NO.RMAPIP412392-E0EP) (FOR EXAMINATION, TEST OR ANALYSIS PURPOSE)MOXIFLOXACIN HCL (CAS# 186826-86-8) (CUST. PART NO.RMAPIP412","address":"40\/1, MOHABEWALA INDUSTRIAL AREA","city":"","supplier":"FLAVINE NORTH AMERICA INC","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"WINDLAS BIOTECH LTD","customerCountry":"INDIA","quantity":"62.00","actualQuantity":"62","unit":"KGS","unitRateFc":"350","totalValueFC":"21902.3","currency":"USD","unitRateINR":"30240","date":"29-Apr-2025","totalValueINR":"1874880","totalValueInUsd":"21902.3","indian_port":"Delhi Air","hs_no":"29334900","bill_no":"9781966","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"61 South Paramus Road, Suite 565 Pa ramus, New Jersey 07652 USA NEW JER SEY, , United States United States","customerAddress":"40\/1, MOHABEWALA INDUSTRIAL AREA"}]
    04-Jan-2022
    28-Jun-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.

    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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