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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 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.
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.
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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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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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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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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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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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).
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.
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.
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 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.
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).
