Synopsis
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Australia
DRUG PRODUCT COMPOSITIONS0
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1. Brentan
2. Dactarin
3. Miconasil Nitrate
4. Miconazole
5. Monistat
6. Nitrate, Miconasil
7. Nitrate, Miconazole
8. R 14,889
9. R-14,889
10. R14,889
1. 22832-87-7
2. Andergin
3. Albistat
4. Aflorix
5. Conofite
6. Florid
7. Dermonistat
8. Micatin
9. Gyno-monistat
10. Epi-monistat
11. Gyno-daktar
12. Miconazole (nitrate)
13. M-zole 7 Dual Pack
14. Brentan
15. Daktarin
16. M-zole 3 Combination Pack
17. Vusion
18. Miconazole 7
19. Priconazole
20. Monistat 3
21. Monistat 5
22. Monistat 7
23. (+/-)-miconazole Nitrate
24. R 14,889
25. Nsc 169434
26. Baza Cream Antifungal
27. R 14889
28. Miconazole 3
29. 1-(2-((2,4-dichlorobenzyl)oxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazole Nitrate
30. Monistat 3 Combination Pack
31. Vw4h1cyw1k
32. Nsc-169434
33. R18134 Nitrate
34. Mls000028674
35. Monistat 1 Combination Pack
36. Miconazole 7 Combination Pack
37. 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1h-imidazole; Nitric Acid
38. 1h-imidazole, 1-(2-(2,4-dichlorophenyl)-2-((2,4-dichlorophenyl)methoxy)ethyl)-, Mononitrate
39. (+/-)-miconazole Nitrate Salt
40. Deralbine
41. Mezolitan
42. Micotef
43. Smr000058733
44. Crimak
45. Daktarin Talc
46. Monistat (tn)
47. Gyno-daktarin
48. Miconal Ecobi
49. 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole;nitric Acid
50. (+-)-miconazole Nitrate
51. R-14889
52. Lotrimin Af Powder
53. Fungisdin
54. Lotrimin Af Spray Liquid
55. Miconazole 1
56. Lotrimin Af Powder Aerosol
57. Monistat Dual-pak
58. 1-[2-(2,4-dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl]-1h-imidazole Nitrate
59. 75319-48-1
60. Monistat 7 Combination Pack
61. Monistat-3 Combination Pack
62. Monistat Cream & Suppositories
63. Nsc169434
64. Miconazole Nitrate Combination Pack
65. Einecs 245-256-6
66. Unii-vw4h1cyw1k
67. Mfcd00058161
68. Lotrimin Af Jock-itch Powder Aerosol
69. Miconazole 3 Combination Pack
70. Baza Cream
71. Monistat Nitrate
72. Sr-01000000271
73. Miconazoli Nitras
74. Miconazol Nitrate
75. 1-(2-(2,4-dichlorobenzyloxy)-2-(2,4-dichlorophenyl)ethyl)-1h-imidazole Nitrate
76. Micatin (tn)
77. Miconazole Nitrate [usan:usp:jan]
78. Monistat 3 Combination Pack (prefilled)
79. Miconazole Nitrate Usp
80. Cpd000058733
81. Miconazole Nitrate,(s)
82. Opera_id_1059
83. 1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)imidazole Mononitrate
84. Component Of Monistat Cream
85. Baza Cream [vandf]
86. Nsc 169434 Nitrate
87. Chembl1559
88. Schembl15799
89. Mls001148223
90. Mls002548903
91. Spectrum1500413
92. Regid_for_cid_68553
93. Miconazole Nitrate [mi]
94. Miconazole Nitrate [jan]
95. Hms500h18
96. Hy-b0454a
97. Miconazole Nitrate (jp17/usp)
98. Dtxsid50996767
99. Miconazole Nitrate [inci]
100. Miconazole Nitrate [usan]
101. Hms1920n21
102. Hms2091f16
103. Hms2233o22
104. Hms3259m05
105. Hms3655d05
106. Miconazole Nitrate [vandf]
107. Pharmakon1600-01500413
108. Miconazole Nitrate [mart.]
109. Amy11000
110. Bcp13696
111. Miconazole Nitrate [usp-rs]
112. Miconazole Nitrate [who-dd]
113. Miconazole Nitrate [who-ip]
114. Ccg-39756
115. Nsc757119
116. S1956
117. Akos015895065
118. Akos015962190
119. Ab02339
120. Miconazole Nitrate [green Book]
121. Nc00461
122. Nsc-757119
123. 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-1h-imidazole Nitrate
124. Imidazole, 1-(2,4-dichloro-beta-((2,4-dichlorobenzyl)oxy)phenethyl)-, Mononitrate
125. Miconazole Nitrate [orange Book]
126. Miconazole Nitrate [ep Monograph]
127. Miconazoli Nitras [who-ip Latin]
128. Ncgc00094728-01
129. Ncgc00094728-02
130. Ncgc00094728-03
131. As-13575
132. Bm166180
133. Miconazole Nitrate [usp Monograph]
134. Vusion Component Miconazole Nitrate
135. Easotic Component Miconazole Nitrate
136. Db-046005
137. Ft-0628943
138. Ft-0628944
139. M-206
140. M1769
141. Miconazole Nitrate Component Of Vusion
142. Sw196614-3
143. Aluminum Hydroxideoxide(al(oh)o),hydrate(9ci)
144. Miconazole Nitrate Component Of Easotic
145. C08070
146. D00882
147. Miconazole Nitrate [ema Epar Veterinary]
148. [2,4-dichlorobenzyloxy)phenethyl]imidazole Nitrate
149. (+/-)-miconazole Nitrate Salt, Imidazole Antibiotic
150. Aluminum Hydroxideoxide (al(oh)o), Hydrate (9ci)
151. J-014876
152. Sr-01000000271-2
153. ( Inverted Exclamation Marka)-miconazole Nitrate Salt
154. Q27292045
155. 1-[2,4-dichlorobenzyl)oxy]phenethyl]imidazole Mononitrate
156. 1-(2,4-dichloro-ss-[(2,4-dichlorobenzyl)oxy]phenethyl)imidazole
157. Miconazole Nitrate, British Pharmacopoeia (bp) Reference Standard
158. Miconazole Nitrate, European Pharmacopoeia (ep) Reference Standard
159. 1-[2,4-dichloro-b-[(2,4-dichlorobenzyl)oxy]phenethyl]imidazole Mononitrate
160. Miconazole Nitrate, United States Pharmacopeia (usp) Reference Standard
161. 1-(2,4-dichloro-.beta.-((2,4-dichlorobenezyl)oxy)phenethyl)imidazole Mononitrate
162. 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole;nitric Acid.
163. 1h-imidazole,1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-,mononitrate
164. 1h-imidazole,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-, Mononitrate
165. Imidazole,4-dichloro-.beta.-[(2,4-dichlorobenzyl)oxy]phenethyl]-, Mononitrate
166. (+/-)-miconazole Nitrate Salt, Pharmaceutical Secondary Standard; Certified Reference Material
167. 1h-imidazole, 1-[2-(2,4-dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]-, Nitrate (1:1)
| Molecular Weight | 479.1 g/mol |
|---|---|
| Molecular Formula | C18H15Cl4N3O4 |
| Hydrogen Bond Donor Count | 1 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 6 |
| Exact Mass | 478.978717 g/mol |
| Monoisotopic Mass | 476.981667 g/mol |
| Topological Polar Surface Area | 93.1 Ų |
| Heavy Atom Count | 29 |
| Formal Charge | 0 |
| Complexity | 441 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 0 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 18 | |
|---|---|
| Drug Name | Monistat 7 combination pack |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream, suppository |
| Route | Topical, vaginal |
| Strength | 2%,100mg |
| Market Status | Over the Counter |
| Company | Insight Pharms |
| 2 of 18 | |
|---|---|
| Drug Name | Monistat-3 combination pack |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream, suppository |
| Route | Topical, vaginal |
| Strength | 2%,200mg |
| Market Status | Over the Counter |
| Company | Insight Pharms |
| 3 of 18 | |
|---|---|
| Drug Name | M-zole 3 combination pack |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream, suppository |
| Route | Topical, vaginal |
| Strength | 2%,200mg |
| Market Status | Over the Counter |
| Company | Actavis Mid Atlantic |
| 4 of 18 | |
|---|---|
| Drug Name | Miconazole 7 |
| Drug Label | Miconazole Nitrate Vaginal Suppositories USP, 200 mg are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, 1-[2,4-Dichloro--[(2,4- dichlorobenzyl)oxy] phenethyl]-imidazole mononitrate, 200 mg, in a hydrogen... |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream |
| Route | Vaginal |
| Strength | 2% |
| Market Status | Over the Counter |
| Company | Actavis Mid Atlantic |
| 5 of 18 | |
|---|---|
| Drug Name | Miconazole nitrate |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream; Suppository; Cream, suppository |
| Route | topical, vaginal; Vaginal; Topical, vaginal |
| Strength | 200mg; 100mg; 2%; 4%; 2%,1.2gm |
| Market Status | Over the Counter; Prescription |
| Company | Taro; Perrigo R And D; Actavis Mid Atlantic; Perrigo; G And W Labs |
| 6 of 18 | |
|---|---|
| Drug Name | Miconazole nitrate combination pack |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream, suppository |
| Route | Topical, vaginal |
| Strength | 2%,200mg |
| Market Status | Over the Counter |
| Company | Perrigo |
| 7 of 18 | |
|---|---|
| Drug Name | Monistat 3 |
| Drug Label | MONISTAT 3 Vaginal Suppositories are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, 1-[2,4-Dichloro--[(2,4-dichlorobenzyl)oxy]phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil bas... |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream; Suppository |
| Route | Vaginal |
| Strength | 200mg; 4% |
| Market Status | Over the Counter; Prescription |
| Company | Insight Pharms |
| 8 of 18 | |
|---|---|
| Drug Name | Monistat 3 combination pack |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream |
| Route | Topical, vaginal |
| Strength | 2%,4% |
| Market Status | Over the Counter |
| Company | Insight Pharms |
| 9 of 18 | |
|---|---|
| Drug Name | Monistat 7 |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream; Suppository |
| Route | Vaginal |
| Strength | 100mg; 2% |
| Market Status | Over the Counter |
| Company | Insight Pharms |
| 10 of 18 | |
|---|---|
| Drug Name | Monistat 7 combination pack |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream, suppository |
| Route | Topical, vaginal |
| Strength | 2%,100mg |
| Market Status | Over the Counter |
| Company | Insight Pharms |
| 11 of 18 | |
|---|---|
| Drug Name | Monistat-3 combination pack |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream, suppository |
| Route | Topical, vaginal |
| Strength | 2%,200mg |
| Market Status | Over the Counter |
| Company | Insight Pharms |
| 12 of 18 | |
|---|---|
| Drug Name | M-zole 3 combination pack |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream, suppository |
| Route | Topical, vaginal |
| Strength | 2%,200mg |
| Market Status | Over the Counter |
| Company | Actavis Mid Atlantic |
| 13 of 18 | |
|---|---|
| Drug Name | Miconazole 7 |
| Drug Label | Miconazole Nitrate Vaginal Suppositories USP, 200 mg are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, 1-[2,4-Dichloro--[(2,4- dichlorobenzyl)oxy] phenethyl]-imidazole mononitrate, 200 mg, in a hydrogen... |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream |
| Route | Vaginal |
| Strength | 2% |
| Market Status | Over the Counter |
| Company | Actavis Mid Atlantic |
| 14 of 18 | |
|---|---|
| Drug Name | Miconazole nitrate |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream; Suppository; Cream, suppository |
| Route | topical, vaginal; Vaginal; Topical, vaginal |
| Strength | 200mg; 100mg; 2%; 4%; 2%,1.2gm |
| Market Status | Over the Counter; Prescription |
| Company | Taro; Perrigo R And D; Actavis Mid Atlantic; Perrigo; G And W Labs |
| 15 of 18 | |
|---|---|
| Drug Name | Miconazole nitrate combination pack |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream, suppository |
| Route | Topical, vaginal |
| Strength | 2%,200mg |
| Market Status | Over the Counter |
| Company | Perrigo |
| 16 of 18 | |
|---|---|
| Drug Name | Monistat 3 |
| Drug Label | MONISTAT 3 Vaginal Suppositories are white to off-white suppositories, each containing the antifungal agent, miconazole nitrate, 1-[2,4-Dichloro--[(2,4-dichlorobenzyl)oxy]phenethyl]-imidazole mononitrate, 200 mg, in a hydrogenated vegetable oil bas... |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream; Suppository |
| Route | Vaginal |
| Strength | 200mg; 4% |
| Market Status | Over the Counter; Prescription |
| Company | Insight Pharms |
| 17 of 18 | |
|---|---|
| Drug Name | Monistat 3 combination pack |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream |
| Route | Topical, vaginal |
| Strength | 2%,4% |
| Market Status | Over the Counter |
| Company | Insight Pharms |
| 18 of 18 | |
|---|---|
| Drug Name | Monistat 7 |
| Active Ingredient | Miconazole nitrate |
| Dosage Form | Cream; Suppository |
| Route | Vaginal |
| Strength | 100mg; 2% |
| Market Status | Over the Counter |
| Company | Insight Pharms |
14-alpha Demethylase Inhibitors
Compounds that specifically inhibit STEROL 14-DEMETHYLASE. A variety of azole-derived ANTIFUNGAL AGENTS act through this mechanism. (See all compounds classified as 14-alpha Demethylase Inhibitors.)
Cytochrome P-450 CYP2C9 Inhibitors
Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP2C9. (See all compounds classified as Cytochrome P-450 CYP2C9 Inhibitors.)
Antifungal Agents
Substances that destroy fungi by suppressing their ability to grow or reproduce. They differ from FUNGICIDES, INDUSTRIAL because they defend against fungi present in human or animal tissues. (See all compounds classified as Antifungal Agents.)
Cytochrome P-450 CYP3A Inhibitors
Drugs and compounds which inhibit or antagonize the biosynthesis or actions of CYTOCHROME P-450 CYP3A. (See all compounds classified as Cytochrome P-450 CYP3A Inhibitors.)
API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Jai Radhe Sales is your partner for all your sourcing needs.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-10-05
Pay. Date : 2015-09-28
DMF Number : 10518
Submission : 1993-09-30
Status : Active
Type : II
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Drugs in Development
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DOSAGE - CREAM;VAGINAL - 2%
USFDA APPLICATION NUMBER - 17450
DOSAGE - CREAM, SUPPOSITORY;TOPICAL, VAGINAL ...DOSAGE - CREAM, SUPPOSITORY;TOPICAL, VAGINAL - 2%,200MG
USFDA APPLICATION NUMBER - 20670
DOSAGE - OINTMENT;TOPICAL - 0.25%;81.35%;15%
USFDA APPLICATION NUMBER - 21026
DOSAGE - CREAM, INSERT;TOPICAL, VAGINAL - 2%,...DOSAGE - CREAM, INSERT;TOPICAL, VAGINAL - 2%,1.2GM
USFDA APPLICATION NUMBER - 21308
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ABOUT THIS PAGE
56
PharmaCompass offers a list of Miconazole Nitrate 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 Miconazole Nitrate manufacturer or Miconazole Nitrate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Miconazole Nitrate manufacturer or Miconazole Nitrate supplier.
PharmaCompass also assists you with knowing the Miconazole Nitrate API Price utilized in the formulation of products. Miconazole Nitrate API Price is not always fixed or binding as the Miconazole Nitrate Price is obtained through a variety of data sources. The Miconazole Nitrate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Miconazole Nitrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Miconazole Nitrate, including repackagers and relabelers. The FDA regulates Miconazole Nitrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Miconazole Nitrate 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 Miconazole Nitrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Miconazole Nitrate supplier is an individual or a company that provides Miconazole Nitrate active pharmaceutical ingredient (API) or Miconazole Nitrate finished formulations upon request. The Miconazole Nitrate suppliers may include Miconazole Nitrate API manufacturers, exporters, distributors and traders.
click here to find a list of Miconazole Nitrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Miconazole Nitrate DMF (Drug Master File) is a document detailing the whole manufacturing process of Miconazole Nitrate active pharmaceutical ingredient (API) in detail. Different forms of Miconazole Nitrate DMFs exist exist since differing nations have different regulations, such as Miconazole Nitrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Miconazole Nitrate DMF submitted to regulatory agencies in the US is known as a USDMF. Miconazole Nitrate USDMF includes data on Miconazole Nitrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Miconazole Nitrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Miconazole Nitrate 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 Miconazole Nitrate Drug Master File in Japan (Miconazole Nitrate JDMF) empowers Miconazole Nitrate 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 Miconazole Nitrate JDMF during the approval evaluation for pharmaceutical products. At the time of Miconazole Nitrate 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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A Miconazole Nitrate CEP of the European Pharmacopoeia monograph is often referred to as a Miconazole Nitrate Certificate of Suitability (COS). The purpose of a Miconazole Nitrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Miconazole Nitrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Miconazole Nitrate to their clients by showing that a Miconazole Nitrate CEP has been issued for it. The manufacturer submits a Miconazole Nitrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Miconazole Nitrate CEP holder for the record. Additionally, the data presented in the Miconazole Nitrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Miconazole Nitrate DMF.
A Miconazole Nitrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Miconazole Nitrate 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 Miconazole Nitrate written confirmation (Miconazole Nitrate WC) is an official document issued by a regulatory agency to a Miconazole Nitrate manufacturer, verifying that the manufacturing facility of a Miconazole Nitrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Miconazole Nitrate APIs or Miconazole Nitrate finished pharmaceutical products to another nation, regulatory agencies frequently require a Miconazole Nitrate 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 Miconazole Nitrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Miconazole Nitrate 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 Miconazole Nitrate 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 Miconazole Nitrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Miconazole Nitrate NDC to their finished compounded human drug products, they may choose to do so.
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Miconazole Nitrate 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 Miconazole Nitrate 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 Miconazole Nitrate GMP manufacturer or Miconazole Nitrate GMP API supplier for your needs.
A Miconazole Nitrate CoA (Certificate of Analysis) is a formal document that attests to Miconazole Nitrate's compliance with Miconazole Nitrate specifications and serves as a tool for batch-level quality control.
Miconazole Nitrate CoA mostly includes findings from lab analyses of a specific batch. For each Miconazole Nitrate 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.
Miconazole Nitrate may be tested according to a variety of international standards, such as European Pharmacopoeia (Miconazole Nitrate EP), Miconazole Nitrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Miconazole Nitrate USP).
