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
Jai Radhe Sales is your partner for all your sourcing needs.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
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.
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6982
Submission : 1987-05-27
Status : Active
Type : II
Registration Number : 223MF10006
Registrant's Address : 59, You Shih Road, Youth Industrial District, Dajia, Taichung, Taiwan 43767, R. O. C.
Initial Date of Registration : 2011-01-14
Latest Date of Registration :
NDC Package Code : 52935-0009
Start Marketing Date : 1987-05-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9540
Submission : 1992-02-10
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6870
Submission : 1987-03-05
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-03-31
Pay. Date : 2023-03-29
DMF Number : 7376
Submission : 1988-03-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8205
Submission : 1989-09-06
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-10-05
Pay. Date : 2015-09-28
DMF Number : 10518
Submission : 1993-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6982
Submission : 1987-05-27
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8095
Submission : 1989-06-07
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8471
Submission : 1990-03-21
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6882
Submission : 1987-03-16
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4653
Submission : 1982-09-13
Status : Inactive
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Certificate Number : CEP 1998-146 - Rev 04
Status : Valid
Issue Date : 2024-08-19
Type : Chemical
Substance Number : 513
Certificate Number : R2-CEP 1995-008 - Rev 04
Status : Valid
Issue Date : 2023-03-01
Type : Chemical
Substance Number : 513
Certificate Number : R0-CEP 1998-153 - Rev 01
Status : Withdrawn by Holder
Issue Date : 2001-12-18
Type : Chemical
Substance Number : 513
Certificate Number : R1-CEP 2002-100 - Rev 09
Status : Valid
Issue Date : 2022-05-23
Type : Chemical
Substance Number : 513
Miconazole Nitrate, Micronised
Certificate Number : R0-CEP 2020-052 - Rev 00
Status : Valid
Issue Date : 2021-08-10
Type : Chemical
Substance Number : 513
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
Registration Number : 219MF10167
Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium
Initial Date of Registration : 2007-05-21
Latest Date of Registration : 2007-05-21
Registration Number : 307MF10042
Registrant's Address : Strada Rivoltana, km 6/7, 20053 Rodano (MI), Italy
Initial Date of Registration : 2025-03-12
Latest Date of Registration : 2025-03-12
Registration Number : 223MF10006
Registrant's Address : 59, You Shih Road, Youth Industrial District, Dajia, Taichung, Taiwan 43767, R. O. C.
Initial Date of Registration : 2011-01-14
Latest Date of Registration : 2020-05-25
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]EU WC
Miconazole Nitrate USP/BP/Ph.Eur/ IP/JP
Date of Issue : 2025-08-08
Valid Till : 2028-07-07
Written Confirmation Number : WC-0055
Address of the Firm : Plot No. 19 & 20/2, MIDC, Dhatav, Taluka: Roha, District-Raigad, Maharashtra, In...
Miconazole Nitrate BP/USP/Ph.Eur
Date of Issue : 2024-05-22
Valid Till : 2027-01-28
Written Confirmation Number : WC-0256
Address of the Firm : N.H. No. 08, Near GRID, Kabilpore-396424, Navsari, Gujarat, India
Date of Issue : 2022-11-08
Valid Till : 2025-02-07
Written Confirmation Number : WC-0153
Address of the Firm : Plot No. L-6, MIDC Taloja, Tal.Panvel, District-Raigad-41 0208, Maharashtra, Ind...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 50923-1213
Start Marketing Date : 2014-02-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 68754-201
Start Marketing Date : 2017-12-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : DRUG FOR FURTHER PROCESSING
NDC Package Code : 49706-5971
Start Marketing Date : 2010-01-08
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 49706-5977
Start Marketing Date : 2010-09-14
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 43285-0288
Start Marketing Date : 2015-07-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 38779-0038
Start Marketing Date : 2014-06-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
NDC Package Code : 17337-0551
Start Marketing Date : 2024-09-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 53069-0740
Start Marketing Date : 1991-02-15
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 60524-001
Start Marketing Date : 2015-01-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 68981-035
Start Marketing Date : 2021-04-21
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales, founded in 1999, is a global distributor specializing in high-quality pharmaceutical ingredients from India. It offers complete sourcing solutions, technical and r...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...
Emay Pharmaceuticals is a GMP-certified API manufacturing company.
About the Company : Emay Pharmaceuticals Pvt Ltd operates as the merchant export division of M/s. Bhavna Laboratories Pvt Ltd. The company is a GMP-approved API manufacturer with over three decades of...
Gonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.
About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Established in 1991, Pharm-Rx is an importer and distributor of active ingredients serving the pharmaceutical, nutritional supplement, and food industries. The company follows a hi...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
About the Company : Zeon Pharma Industries India Pvt. Ltd. is an ISO 9001:2015, cGMP, and WHO-GMP certified company with a dedicated manufacturing facility for Bulk Drugs (APIs), phytochemicals, herba...
Delivering Quality APIs, Drug Intermediates, and Specialty Chemicals to Over 50 Countries Across the Globe.
About the Company : Zeal Medipharma is a Star-rated Export House serving customers in over 50 countries for more than two decades. The company specializes in sourcing and exporting APIs for human and ...
Willow Birch Pharma delivers trusted, high-quality APIs nationwide with unmatched service, compliance, and competitive value.
About the Company : Willow Birch Pharma, Inc. is a premier supplier of bulk APIs to North American Compounding Pharmacies, sourcing from FDA registered and GMP manufacturers. With licenses in all 50 s...
About the Company : Gurvey & Berry offers an impressive lineup of bulk raw materials, but we are much more than products by the kilo or tonne. With 4 decades behind us, and our Service First philosoph...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
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Drugs in Development
Details:
MCZ-DB (miconazole nitrate + domiphen bromide) vaginal cream is being evaluated in phase 2 clinical trials for the treatment of acute vulvovaginal candidiasis.
Lead Product(s): Miconazole Nitrate,Domiphen Bromide
Therapeutic Area: Infections and Infectious Diseases Brand Name: MCZ-DB
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Purna Female Healthcare
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 30, 2024
Lead Product(s) : Miconazole Nitrate,Domiphen Bromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Purna Female Healthcare
Deal Size : Inapplicable
Deal Type : Inapplicable
Hyloris and Purna Report Positive Results from Phase 2 Trial in Acute VVC
Details : MCZ-DB (miconazole nitrate + domiphen bromide) vaginal cream is being evaluated in phase 2 clinical trials for the treatment of acute vulvovaginal candidiasis.
Product Name : MCZ-DB
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 30, 2024
Details:
Miconazole Nitrate is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Candidiasis, Vulvovaginal.
Lead Product(s): Miconazole Nitrate,Domiphen Bromide
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 24, 2021
Lead Product(s) : Miconazole Nitrate,Domiphen Bromide
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Miconazole Nitrate is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Candidiasis, Vulvovaginal.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
March 24, 2021
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
1-(2,4-Dichlorophenyl-2-(1H- Imidazolyl)-Ethanol
CAS Number : 24155-42-8
End Use API : Miconazole Nitrate
About The Company : Incorporated in 2011, SNA Health Care Pvt. Ltd., a WHO-GMP Certified API Manufacturing Company involved in the manufacture and export of Active Pharmaceutical I...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MONISTAT-DERM
Dosage Form : CREAM;TOPICAL
Dosage Strength : 2%
Packaging :
Approval Date : 1982-01-01
Application Number : 17494
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MONISTAT-DERM
Dosage Form : LOTION;TOPICAL
Dosage Strength : 2%
Packaging :
Approval Date : 1982-01-01
Application Number : 17739
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : MONISTAT 5
Dosage Form : TAMPON;VAGINAL
Dosage Strength : 100MG
Packaging :
Approval Date : 1989-10-27
Application Number : 18592
Regulatory Info : DISCN
Registration Country : USA
Regulatory Info :
Registration Country : USA
Brand Name : MONISTAT DUAL- PAK
Dosage Form : CREAM, SUPPOSITORY;TOPICAL, VAGINAL
Dosage Strength : 1.2GM;2%
Packaging :
Approval Date :
Application Number : 20968
Regulatory Info :
Registration Country : USA
Regulatory Info : OTC
Registration Country : USA
Brand Name : MONISTAT 7
Dosage Form : CREAM;VAGINAL
Dosage Strength : 2%
Packaging :
Approval Date : 1991-02-15
Application Number : 17450
Regulatory Info : OTC
Registration Country : USA
Regulatory Info : OTC
Registration Country : USA
Brand Name : MONISTAT 7
Dosage Form : SUPPOSITORY;VAGINAL
Dosage Strength : 100MG
Packaging :
Approval Date : 1991-02-15
Application Number : 18520
Regulatory Info : OTC
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : MONISTAT 3
Dosage Form : SUPPOSITORY;VAGINAL
Dosage Strength : 200MG
Packaging :
Approval Date : 1984-08-15
Application Number : 18888
Regulatory Info : RX
Registration Country : USA
Regulatory Info : OTC
Registration Country : USA
Brand Name : MONISTAT 7 COMBINATION PACK
Dosage Form : CREAM, SUPPOSITORY;TOPICAL, VAGINAL
Dosage Strength : 2%,100MG
Packaging :
Approval Date : 1993-04-26
Application Number : 20288
Regulatory Info : OTC
Registration Country : USA
Regulatory Info : OTC
Registration Country : USA
Brand Name : MONISTAT 3 COMBINATION PACK
Dosage Form : CREAM, SUPPOSITORY;TOPICAL, VAGINAL
Dosage Strength : 2%,200MG
Packaging :
Approval Date : 1996-04-16
Application Number : 20670
Regulatory Info : OTC
Registration Country : USA
Regulatory Info : OTC
Registration Country : USA
Brand Name : MONISTAT 3
Dosage Form : CREAM;VAGINAL
Dosage Strength : 4%
Packaging :
Approval Date : 1998-03-30
Application Number : 20827
Regulatory Info : OTC
Registration Country : USA
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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Grade : Topical, Parenteral
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23
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 Daktarin talc manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Daktarin talc, including repackagers and relabelers. The FDA regulates Daktarin talc manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Daktarin talc 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 Daktarin talc manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Daktarin talc supplier is an individual or a company that provides Daktarin talc active pharmaceutical ingredient (API) or Daktarin talc finished formulations upon request. The Daktarin talc suppliers may include Daktarin talc API manufacturers, exporters, distributors and traders.
click here to find a list of Daktarin talc suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Daktarin talc DMF (Drug Master File) is a document detailing the whole manufacturing process of Daktarin talc active pharmaceutical ingredient (API) in detail. Different forms of Daktarin talc DMFs exist exist since differing nations have different regulations, such as Daktarin talc USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Daktarin talc DMF submitted to regulatory agencies in the US is known as a USDMF. Daktarin talc USDMF includes data on Daktarin talc's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Daktarin talc USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Daktarin talc 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 Daktarin talc Drug Master File in Japan (Daktarin talc JDMF) empowers Daktarin talc 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 Daktarin talc JDMF during the approval evaluation for pharmaceutical products. At the time of Daktarin talc 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 Daktarin talc suppliers with JDMF on PharmaCompass.
A Daktarin talc CEP of the European Pharmacopoeia monograph is often referred to as a Daktarin talc Certificate of Suitability (COS). The purpose of a Daktarin talc CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Daktarin talc EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Daktarin talc to their clients by showing that a Daktarin talc CEP has been issued for it. The manufacturer submits a Daktarin talc CEP (COS) as part of the market authorization procedure, and it takes on the role of a Daktarin talc CEP holder for the record. Additionally, the data presented in the Daktarin talc CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Daktarin talc DMF.
A Daktarin talc CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Daktarin talc 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 Daktarin talc suppliers with CEP (COS) on PharmaCompass.
A Daktarin talc written confirmation (Daktarin talc WC) is an official document issued by a regulatory agency to a Daktarin talc manufacturer, verifying that the manufacturing facility of a Daktarin talc active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Daktarin talc APIs or Daktarin talc finished pharmaceutical products to another nation, regulatory agencies frequently require a Daktarin talc WC (written confirmation) as part of the regulatory process.
click here to find a list of Daktarin talc 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 Daktarin talc as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Daktarin talc 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 Daktarin talc 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 Daktarin talc and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Daktarin talc NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Daktarin talc suppliers with NDC on PharmaCompass.
Daktarin talc 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 Daktarin talc 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 Daktarin talc GMP manufacturer or Daktarin talc GMP API supplier for your needs.
A Daktarin talc CoA (Certificate of Analysis) is a formal document that attests to Daktarin talc's compliance with Daktarin talc specifications and serves as a tool for batch-level quality control.
Daktarin talc CoA mostly includes findings from lab analyses of a specific batch. For each Daktarin talc 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.
Daktarin talc may be tested according to a variety of international standards, such as European Pharmacopoeia (Daktarin talc EP), Daktarin talc JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Daktarin talc USP).
