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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
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
| Molecular Weight | 437.9 g/mol |
|---|---|
| Molecular Formula | C21H25ClFN3O4 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 8 |
| Rotatable Bond Count | 4 |
| Exact Mass | 437.1517621 g/mol |
| Monoisotopic Mass | 437.1517621 g/mol |
| Topological Polar Surface Area | 82.1 Ų |
| Heavy Atom Count | 30 |
| Formal Charge | 0 |
| Complexity | 727 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 2 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 8 | |
|---|---|
| Drug Name | Avelox |
| Drug Label | DESCRIPTIONAVELOX (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 Ingredient | Moxifloxacin hydrochloride |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | eq 400mg base; 400mg |
| Market Status | Prescription |
| Company | Bayer Pharms; Bayer Hlthcare |
| 2 of 8 | |
|---|---|
| Drug Name | Moxeza |
| PubMed Health | Moxifloxacin |
| Drug Classes | Antibiotic |
| Drug Label | MOXEZA 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 Ingredient | Moxifloxacin hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.5% base |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 3 of 8 | |
|---|---|
| Drug Name | Moxifloxacin hydrochloride |
| PubMed Health | Moxifloxacin |
| Drug Classes | Antibiotic |
| Drug Label | DESCRIPTIONAVELOX (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 Ingredient | Moxifloxacin hydrochloride |
| Dosage Form | Solution/drops; Tablet; Solution |
| Route | Ophthalmic; Oral; ophthalmic |
| Strength | 0.5%; eq 0.5% base; eq 400mg base |
| Market Status | Tentative Approval; Prescription |
| Company | Apotex; Aurobindo Pharma; Teva Pharms Usa; Torrent Pharms; Lupin; Teva Pharms; Dr Reddys Labs |
| 4 of 8 | |
|---|---|
| Drug Name | Vigamox |
| PubMed Health | Moxifloxacin |
| Drug Classes | Antibiotic |
| Drug Label | VIGAMOX (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 Ingredient | Moxifloxacin hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.5% base |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 5 of 8 | |
|---|---|
| Drug Name | Avelox |
| Drug Label | DESCRIPTIONAVELOX (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 Ingredient | Moxifloxacin hydrochloride |
| Dosage Form | Tablet |
| Route | oral; Oral |
| Strength | eq 400mg base; 400mg |
| Market Status | Prescription |
| Company | Bayer Pharms; Bayer Hlthcare |
| 6 of 8 | |
|---|---|
| Drug Name | Moxeza |
| PubMed Health | Moxifloxacin |
| Drug Classes | Antibiotic |
| Drug Label | MOXEZA 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 Ingredient | Moxifloxacin hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.5% base |
| Market Status | Prescription |
| Company | Alcon Pharms |
| 7 of 8 | |
|---|---|
| Drug Name | Moxifloxacin hydrochloride |
| PubMed Health | Moxifloxacin |
| Drug Classes | Antibiotic |
| Drug Label | DESCRIPTIONAVELOX (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 Ingredient | Moxifloxacin hydrochloride |
| Dosage Form | Solution/drops; Tablet; Solution |
| Route | Ophthalmic; Oral; ophthalmic |
| Strength | 0.5%; eq 0.5% base; eq 400mg base |
| Market Status | Tentative Approval; Prescription |
| Company | Apotex; Aurobindo Pharma; Teva Pharms Usa; Torrent Pharms; Lupin; Teva Pharms; Dr Reddys Labs |
| 8 of 8 | |
|---|---|
| Drug Name | Vigamox |
| PubMed Health | Moxifloxacin |
| Drug Classes | Antibiotic |
| Drug Label | VIGAMOX (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 Ingredient | Moxifloxacin hydrochloride |
| Dosage Form | Solution/drops |
| Route | Ophthalmic |
| Strength | eq 0.5% base |
| Market Status | Prescription |
| Company | Alcon Pharms |
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
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.)
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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
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
DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% ...DOSAGE - SOLUTION/DROPS;OPHTHALMIC - EQ 0.5% BASE
USFDA APPLICATION NUMBER - 21598
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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.
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.
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.
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.
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.
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).
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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.
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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.
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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).
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.
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.
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.
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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.
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).
