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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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DMF Review : Reviewed
Rev. Date : 2013-01-30
Pay. Date : 2013-01-02
DMF Number : 16999
Submission : 2003-12-02
Status : Active
Type : II
Date of Issue : 2022-06-15
Valid Till : 2025-06-16
Written Confirmation Number : WC-0034
Address of the Firm :
NDC Package Code : 55111-064
Start Marketing Date : 2012-07-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Registration Date : 2021-02-05
Registration Number : 20201211-209-J-529(1)
Manufacturer Name : Dr. Reddy's Laboratories Limited
Manufacturer Address : Chemical Technical Operations-Unit-II Plot No. 1, 75A, 75B, 105, 110, 111 & 112 Sri Venkateswara Co-operative Industrial Estate Bollaram Village, Jinnaram Mandal, Sangareddy District, Telangana, 502325 INDIA
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Status : Active
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NDC Package Code : 58032-0131
Start Marketing Date : 2017-12-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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Moxifloxacin Hydrochloride (USP/Ph.Eur)
Date of Issue : 2022-06-15
Valid Till : 2025-06-16
Written Confirmation Number : WC-0034
Address of the Firm : Chemical Technical Operations-Unit II, Plot Nos. 1, 75A, 75B, 105, 110, 111 & 1...
Moxifloxacin Hydrochloride (IH/USP/BP/Ph.Eur.)
Date of Issue : 2013-08-30
Valid Till : 2016-07-02
Written Confirmation Number : WC-0240
Address of the Firm : Plot No.145-150,153,154A,IDA, Kondapally, Ibrahimpatnam Mandal,Krishna District-...
Moxifloxacin Hydrochloride (Ph.Eur)
Date of Issue : 2022-06-06
Valid Till : 2025-06-10
Written Confirmation Number : WC-0017
Address of the Firm : Unit No. VIII, Sy. No. 10 & 13, Gaddapotharam Village, I,D.A. Kazipally, Jinnara...
Moxifloxacin Hydrochloride (USP/Ph. Eur)
Date of Issue : 2022-07-04
Valid Till : 2025-07-03
Written Confirmation Number : WC-0040
Address of the Firm : Unit-I, Survey No.213, 214 & 255, Bonthapally Village, Jinnaram Mandal, Medak ...
Moxifloxacin Hydrochloride USP
Date of Issue : 2023-03-21
Valid Till : 2025-07-28
Written Confirmation Number : WC-0186
Address of the Firm : Sy. No. 10/G-1, Gaddapotharam Village, Jinnaram Mandal, Sangareddy, Pin-502319, ...
Moxifloxacin Hydrochloride (Ph. Eur.)
Date of Issue : 2019-11-28
Valid Till : 2022-07-02
Written Confirmation Number : WC-0079
Address of the Firm : Plot No.2209, GIDC, Industrial Estate, At & Post Sarigam, Tal-Umbergaon, Valsad-...
Moxifloxacin Hydrochloride (1H)
Date of Issue : 2019-08-16
Valid Till : 2025-08-15
Written Confirmation Number : WC-0022
Address of the Firm : Plot No. 212, A, B, C, D, IDA, Phase II, Pashamylaram (V), Patancheru (M), Sanga...
Moxifloxacin Hydrochloride (USP/BP/EP)
Date of Issue : 2022-05-02
Valid Till : 2025-07-25
Written Confirmation Number : WC-0027
Address of the Firm : Unit-II, Survey No.14, IDA Gaddapotharam (Village), Kazipally, Jinnaram (Mandal)...
Moxifloxacin Hydrochloride (IH)
Date of Issue : 2019-09-09
Valid Till : 2022-09-08
Written Confirmation Number : WC-0197
Address of the Firm : Plot No.1, Additional Phase MIDC, Mahad, Dist. Raigad-402 301, Maharashtra State...
Moxifloxacin Hydrochloride EP/BP
Date of Issue : 2022-08-31
Valid Till : 2025-08-30
Written Confirmation Number : WC-0534
Address of the Firm : 8-5, Phase 1, MIDC Dombivli 3 1 AUG 2022\r\nDombivali I.A. - 421203,\r\nTaluka: ...
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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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A Moxifloxacin Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Moxifloxacin Hydrochloride, including repackagers and relabelers. The FDA regulates Moxifloxacin Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Moxifloxacin Hydrochloride 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Moxifloxacin Hydrochloride supplier is an individual or a company that provides Moxifloxacin Hydrochloride active pharmaceutical ingredient (API) or Moxifloxacin Hydrochloride finished formulations upon request. The Moxifloxacin Hydrochloride suppliers may include Moxifloxacin Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Moxifloxacin Hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Moxifloxacin Hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Moxifloxacin Hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Moxifloxacin Hydrochloride DMFs exist exist since differing nations have different regulations, such as Moxifloxacin Hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Moxifloxacin Hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Moxifloxacin Hydrochloride USDMF includes data on Moxifloxacin Hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Moxifloxacin Hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Moxifloxacin Hydrochloride 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 Drug Master File in Japan (Moxifloxacin Hydrochloride JDMF) empowers Moxifloxacin Hydrochloride 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Moxifloxacin Hydrochloride 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 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 Drug Master File in Korea (Moxifloxacin Hydrochloride KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Moxifloxacin Hydrochloride. The MFDS reviews the Moxifloxacin Hydrochloride KDMF as part of the drug registration process and uses the information provided in the Moxifloxacin Hydrochloride KDMF to evaluate the safety and efficacy of the drug.
After submitting a Moxifloxacin Hydrochloride 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 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Moxifloxacin Hydrochloride suppliers with KDMF on PharmaCompass.
A Moxifloxacin Hydrochloride CEP of the European Pharmacopoeia monograph is often referred to as a Moxifloxacin Hydrochloride Certificate of Suitability (COS). The purpose of a Moxifloxacin Hydrochloride CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Moxifloxacin Hydrochloride EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Moxifloxacin Hydrochloride to their clients by showing that a Moxifloxacin Hydrochloride CEP has been issued for it. The manufacturer submits a Moxifloxacin Hydrochloride CEP (COS) as part of the market authorization procedure, and it takes on the role of a Moxifloxacin Hydrochloride CEP holder for the record. Additionally, the data presented in the Moxifloxacin Hydrochloride CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Moxifloxacin Hydrochloride DMF.
A Moxifloxacin Hydrochloride CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Moxifloxacin Hydrochloride 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 suppliers with CEP (COS) on PharmaCompass.
A Moxifloxacin Hydrochloride written confirmation (Moxifloxacin Hydrochloride WC) is an official document issued by a regulatory agency to a Moxifloxacin Hydrochloride manufacturer, verifying that the manufacturing facility of a Moxifloxacin Hydrochloride active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Moxifloxacin Hydrochloride APIs or Moxifloxacin Hydrochloride finished pharmaceutical products to another nation, regulatory agencies frequently require a Moxifloxacin Hydrochloride WC (written confirmation) as part of the regulatory process.
click here to find a list of Moxifloxacin Hydrochloride suppliers with Written Confirmation (WC) on PharmaCompass.
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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Moxifloxacin Hydrochloride 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Moxifloxacin Hydrochloride NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Moxifloxacin Hydrochloride suppliers with NDC on PharmaCompass.
Moxifloxacin Hydrochloride 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 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 GMP manufacturer or Moxifloxacin Hydrochloride GMP API supplier for your needs.
A Moxifloxacin Hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Moxifloxacin Hydrochloride's compliance with Moxifloxacin Hydrochloride specifications and serves as a tool for batch-level quality control.
Moxifloxacin Hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Moxifloxacin Hydrochloride 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Moxifloxacin Hydrochloride EP), Moxifloxacin Hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Moxifloxacin Hydrochloride USP).
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