Synopsis
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Australia
DRUG PRODUCT COMPOSITIONS0
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1. Acetonide, Triamcinolone
2. Azmacort
3. Cinonide
4. Kenacort A
5. Kenalog
6. Kenalog 40
7. Tricort 40
8. Tricort-40
9. Tricort40
1. 76-25-5
2. Azmacort
3. Nasacort
4. Aristoderm
5. Aristogel
6. Vetalog
7. Kenalog
8. Tricinolon
9. Oralone
10. Rineton
11. Solodelf
12. Tramacin
13. Triacet
14. Triderm
15. Zilretta
16. Nasacort Aq
17. Volon A
18. Triaceton
19. Triacort
20. Triesence
21. Flutex
22. Flutone
23. Oracort
24. Triatex
25. Trymex
26. Allernaze
27. Aristocort A
28. Triam-injekt
29. Adcortyl A
30. Kenalog-h
31. Omcilon A
32. Tri-nasal
33. Nasacort Hfa
34. Coupe-a
35. Kenalog In Orabase
36. Aristocort Acetonide
37. Kenalog-10
38. Kenalog-40
39. Triamcinolone 16,17-acetonide
40. Trivaris
41. Triamcincolone Acetonide
42. Volon A 40
43. Kenacort-a
44. Kenalone
45. Triamcinolone (acetonide)
46. Nasacort Allergy 24 Hour
47. Triamcinolone Acetonide In Absorbase
48. Acetospan
49. Chebi:71418
50. Triamonide 40
51. Fx006
52. 9alpha-fluoro-16alpha-17alpha-isopropyledenedioxyprednisolone
53. Nsc-21916
54. Triamsinolone Acetonide
55. Fx-006
56. Mls000028538
57. (11beta,16alpha)-9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]pregna-1,4-diene-3,20-dione
58. F446c597ka
59. Tac-3
60. Kenalog 40
61. Tricort-40
62. Smr000058335
63. Dsstox_cid_1371
64. Dsstox_rid_76115
65. Dsstox_gsid_21371
66. Extracort
67. Ftorocort
68. Respicort
69. Volonimat
70. (4as,4br,5s,6as,6bs,9ar,10as,10bs)-4b-fluoro-5-hydroxy-6b-(hydroxyacetyl)-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2h-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
71. (4as,4br,5s,6as,6bs,9ar,10as,10bs)-4b-fluoro-6b-glycoloyl-5-hydroxy-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2h-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
72. Ledercort Cream
73. Vetalog (veterinary)
74. Trianex
75. 9alpha-fluoro-16alpha-hydroxyprednisolone 16alpha,17alpha-acetonide
76. Mfcd00056834
77. 9alpha-fluoro-16alpha-17alpha-isopropylidenedioxy-delta-1-hydrocortisone
78. 9-fluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione-16,17-acetonide
79. 9alpha-fluoro-11beta,21-dihydroxy-16alpha,17-isopropylidenedioxy-1,4-pregnadiene,3,20-dione
80. Cas-76-25-5
81. 9alpha-fluoro-11beta,21-dihydroxy-16alpha,17alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione
82. Panolog Ointment (veterinary)
83. Triamcinolone Acetonide [jan]
84. Ccris 5231
85. Mls002638825
86. Einecs 200-948-7
87. Nsc 21916
88. Brn 0060069
89. Nystadermal
90. Audicort
91. Aureocort
92. Remiderm
93. Remotic
94. Silderm
95. Unii-f446c597ka
96. Tri-adcortyl
97. 9alpha-fluoro-16-hydroxyprednisolone Acetonide
98. Gppe Ear Oint
99. 9?-fluoro-11?,21-dihydroxy-16?,17?-isopropylidenedioxypregna-1,4-diene-3,20-dione
100. 9-alpha-fluoro-16-hydroxyprednisolone Acetonide
101. Kenalone, Solodelf
102. Ncgc00023193-04
103. Azmacort (tn)
104. Nasacort (tn)
105. Gppe Ear Dps Cap
106. Adcortyl In Orabase
107. Kenalog (tn)
108. Pevaryl T.c.
109. Xipere
110. Pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17-((1-methylethylidene)bis(oxy))-, (11beta,16alpha)-
111. Triamcinolone-acetonide
112. Asmacort [common Misspelling Of Azmacort]
113. Opera_id_232
114. 9-alpha-fluoro-16-alpha-17-alpha-isopropyledenedioxyprednisolone
115. Triamcinolone Acetonide [usp:inn:ban:jan]
116. 9-alpha-fluoro-16-alpha-hydroxyprednisolone 16-alpha,17-alpha-acetonide
117. 9-alpha-fluoro-16-alpha-17-alpha-isopropylidenedioxy-delta-1-hydrocortisone
118. Schembl4689
119. 9-alpha-fluoro-11-beta,21-dihydroxy-16-alpha-isopropylidenedioxy-1,4-pregnadiene,3,20-dione
120. Chembl1504
121. 5-19-06-00568 (beilstein Handbook Reference)
122. 9-alpha-fluoro-11-beta,21-dihydroxy-16-alpha,17-alpha-isopropylidenedioxypregna-1,4-diene-3,20-dione
123. 9-fluoro-11beta,16alpha,17,21-tetrahydroxypregna-1,4-diene-3,20-dione Cyclic 16,17-acetal With Acetone
124. Mls001148264
125. Mls002207192
126. 9.alpha.-fluoro-16.alpha.-17.alpha.-isopropyledenedioxyprednisolone
127. Gtpl2867
128. Dtxsid6021371
129. Cls1001
130. 9.alpha.-fluoro-16.alpha.-hydroxyprednisolone 16.alpha.,17.alpha.-acetonide
131. Hms2232f22
132. Hms3259a20
133. 9-fluoro-11.beta.,16.alpha.,17,21-tetrahydroxypregna-1,4-diene-3,20-dione Cyclic 16,17-acetal With Acetone
134. 9alpha-fluoro-11beta,21-dihydroxy-16alpha,17-isopropylidenedioxy-1,4-pregnadiene-3,20-dione
135. Cls-1001
136. Hy-b0636
137. Nsc21916
138. Zinc3875481
139. Tox21_110885
140. Tox21_201795
141. Tox21_303014
142. Triamcinolone Acetonide [mi]
143. Bdbm50248362
144. Triamcinolone Acetonide (jp17/usp)
145. Akos015894871
146. Tox21_110885_1
147. Ac-1239
148. Ccg-269068
149. Ks-5330
150. Nc00591
151. Triamcinolone Acetonide [mart.]
152. Triamcinolone Acetonide [vandf]
153. Triamcinolone Acetonide [usp-rs]
154. Triamcinolone Acetonide [who-dd]
155. Ncgc00023193-05
156. Ncgc00023193-06
157. Ncgc00256560-01
158. Ncgc00259344-01
159. (4as,4br,5s,6as,6bs,9ar,10as,10bs)-4b-fluoro-5-hydroxy-6b-(hydroxyacetyl)-4a,6a,8,8-tetramethyl-4a,4b,5,6,6a,6b,9a,10,10a,10b,11,12-dodecahydro-2h,8h-naphtho[2',1':4,5]indeno[1,2-d][1,3]dioxol-2-one
160. Pregna-1,4-diene-3,20-dione, 9-fluoro-11-beta,16-alpha,17,21-tetrahydroxy-, Cyclic 16,17-acetal With Acetone
161. Pregna-1,4-diene-3,20-dione, 9-fluoro-11beta,16alpha,17,21-tetrahydroxy-, Cyclic 16,17-acetal With Acetone
162. Triamcinolone Acetonide [green Book]
163. Triamcinolone Acetonide, Analytical Standard
164. S1628
165. Triamcinolone Acetonide [orange Book]
166. Triamcinolone Acetonide [ep Monograph]
167. C08183
168. D00983
169. Dimethyl2-(3-nitro-2-pyridyl)malonate
170. Mycolog Component Triamcinolone Acetonide
171. Mykacet Component Triamcinolone Acetonide
172. Triamcinolone Acetonide [usp Monograph]
173. 9.alpha.-fluoro-16-hydroxyprednisolone Acetonide
174. Ab00383012-11
175. Ab00383012_12
176. Mytrex A Component Triamcinolone Acetonide
177. Mytrex F Component Triamcinolone Acetonide
178. 056t834
179. A856341
180. Triamcinolone Acetonide 100 Microg/ml In Methanol
181. Triamcinolone Acetonide Component Of Mycolog
182. Triamcinolone Acetonide Component Of Mykacet
183. Q-201855
184. Q2211240
185. Triamcinolone Acetonide 1000 Microg/ml In Methanol
186. Triamcinolone Acetonide Component Of Mytrex A
187. Triamcinolone Acetonide Component Of Mytrex F
188. 9.alpha.-fluoro-11.beta.,4-pregnadiene,3,20-dione
189. Brd-k53790871-001-08-6
190. Triamcinolone Hexacetonide Impurity A [ep Impurity]
191. Triamcinolone Acetonide, European Pharmacopoeia (ep) Reference Standard
192. Triamcinolone Acetonide, United States Pharmacopeia (usp) Reference Standard
193. Triamcinolone Acetonide; 76-25-5; Azmacort; Aristogel; Nasacort;
194. Wln: T F5 E5 B666 Go Io Rv Ahtttt&j A1 Bf Cq E1 Fv1q H1 H1
195. 9.alpha.-fluoro-16.alpha.-17.alpha.-isopropylidenedioxy-.delta.-1-hydrocortisone
196. Pregna-1,20-dione, 9-fluoro-11.beta.,21-dihydroxy-16.alpha.,17-(isopropylidenedioxy)-
197. Triamcinolone Acetonide, Pharmaceutical Secondary Standard; Certified Reference Material
198. 1ta
199. Pregna-1,20-dione, 9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (11.beta.,16.alpha.)-
200. Pregna-1,20-dione, 9-fluoro-11.beta.,16.alpha.,17,21-tetrahydroxy-, Cyclic 16,17-acetal With Acetone
201. Pregna-1,20-dione, 9-fluoro-11.beta.,16.alpha.,17,21-tetrahydroxy-,cyclic 16,17-acetal With Acetone
202. Triamcinolone Acetonide For System Suitability, European Pharmacopoeia (ep) Reference Standard
| Molecular Weight | 434.5 g/mol |
|---|---|
| Molecular Formula | C24H31FO6 |
| XLogP3 | 2.5 |
| Hydrogen Bond Donor Count | 2 |
| Hydrogen Bond Acceptor Count | 7 |
| Rotatable Bond Count | 2 |
| Exact Mass | 434.21046687 g/mol |
| Monoisotopic Mass | 434.21046687 g/mol |
| Topological Polar Surface Area | 93.1 Ų |
| Heavy Atom Count | 31 |
| Formal Charge | 0 |
| Complexity | 925 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 8 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
| 1 of 10 | |
|---|---|
| Drug Name | Kenalog-10 |
| Drug Label | Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP) is triamcinolone acetonide, a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and int... |
| Active Ingredient | Triamcinolone acetonide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 10mg/ml |
| Market Status | Prescription |
| Company | Apothecon |
| 2 of 10 | |
|---|---|
| Drug Name | Kenalog-40 |
| Drug Label | Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS N... |
| Active Ingredient | Triamcinolone acetonide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 40mg/ml |
| Market Status | Prescription |
| Company | Apothecon |
| 3 of 10 | |
|---|---|
| Drug Name | Triamcinolone acetonide |
| Drug Label | Triamcinolone acetonide, USP, the active ingredient in Nasacort HFA Nasal Aerosol, is a glucocorticosteroid with a molecular weight of 434.5, the chemical designation 9-Fluoro-11,16,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-ace... |
| Active Ingredient | Triamcinolone acetonide |
| Dosage Form | Ointment; Spray, metered; Paste; Cream; Lotion |
| Route | Dental; Nasal; Topical |
| Strength | 0.5%; 0.055mg/spray; 0.1%; 0.025% |
| Market Status | Prescription |
| Company | Wockhardt; Taro; Lyne; Fougera Pharms; Teva Pharms; Versapharm; Vintage; Perrigo New York; Wockhardt Eu Operatn |
| 4 of 10 | |
|---|---|
| Drug Name | Triamcinolone acetonide in absorbase |
| Drug Label | TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL is a synthetic corticosteroid with anti-inflammatory action. Each mL of the sterile, aqueous suspension provides 40 mg of triamcinolone acetonide, with sodium chloride for isotonici... |
| Active Ingredient | Triamcinolone acetonide |
| Dosage Form | Ointment |
| Route | Topical |
| Strength | 0.05% |
| Market Status | Prescription |
| Company | Carolina Medcl |
| 5 of 10 | |
|---|---|
| Drug Name | Triesence |
| Active Ingredient | Triamcinolone acetonide |
| Dosage Form | Injectable |
| Route | Intravitreal; suspension |
| Strength | 40mg/ml (40mg/ml); 40mgml |
| Market Status | Prescription |
| Company | Alcon; Alcon Res |
| 6 of 10 | |
|---|---|
| Drug Name | Kenalog-10 |
| Drug Label | Kenalog-10 Injection (triamcinolone acetonide injectable suspension, USP) is triamcinolone acetonide, a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and int... |
| Active Ingredient | Triamcinolone acetonide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 10mg/ml |
| Market Status | Prescription |
| Company | Apothecon |
| 7 of 10 | |
|---|---|
| Drug Name | Kenalog-40 |
| Drug Label | Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS N... |
| Active Ingredient | Triamcinolone acetonide |
| Dosage Form | Injectable |
| Route | Injection |
| Strength | 40mg/ml |
| Market Status | Prescription |
| Company | Apothecon |
| 8 of 10 | |
|---|---|
| Drug Name | Triamcinolone acetonide |
| Drug Label | Triamcinolone acetonide, USP, the active ingredient in Nasacort HFA Nasal Aerosol, is a glucocorticosteroid with a molecular weight of 434.5, the chemical designation 9-Fluoro-11,16,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-ace... |
| Active Ingredient | Triamcinolone acetonide |
| Dosage Form | Ointment; Spray, metered; Paste; Cream; Lotion |
| Route | Dental; Nasal; Topical |
| Strength | 0.5%; 0.055mg/spray; 0.1%; 0.025% |
| Market Status | Prescription |
| Company | Wockhardt; Taro; Lyne; Fougera Pharms; Teva Pharms; Versapharm; Vintage; Perrigo New York; Wockhardt Eu Operatn |
| 9 of 10 | |
|---|---|
| Drug Name | Triamcinolone acetonide in absorbase |
| Drug Label | TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL is a synthetic corticosteroid with anti-inflammatory action. Each mL of the sterile, aqueous suspension provides 40 mg of triamcinolone acetonide, with sodium chloride for isotonici... |
| Active Ingredient | Triamcinolone acetonide |
| Dosage Form | Ointment |
| Route | Topical |
| Strength | 0.05% |
| Market Status | Prescription |
| Company | Carolina Medcl |
| 10 of 10 | |
|---|---|
| Drug Name | Triesence |
| Active Ingredient | Triamcinolone acetonide |
| Dosage Form | Injectable |
| Route | Intravitreal; suspension |
| Strength | 40mg/ml (40mg/ml); 40mgml |
| Market Status | Prescription |
| Company | Alcon; Alcon Res |
Visualisation during vitrectomy
Anti-Inflammatory Agents
Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)
Glucocorticoids
A group of CORTICOSTEROIDS that affect carbohydrate metabolism (GLUCONEOGENESIS, liver glycogen deposition, elevation of BLOOD SUGAR), inhibit ADRENOCORTICOTROPIC HORMONE secretion, and possess pronounced anti-inflammatory activity. They also play a role in fat and protein metabolism, maintenance of arterial blood pressure, alteration of the connective tissue response to injury, reduction in the number of circulating lymphocytes, and functioning of the central nervous system. (See all compounds classified as Glucocorticoids.)
Immunosuppressive Agents
Agents that suppress immune function by one of several mechanisms of action. Classical cytotoxic immunosuppressants act by inhibiting DNA synthesis. Others may act through activation of T-CELLS or by inhibiting the activation of HELPER CELLS. While immunosuppression has been brought about in the past primarily to prevent rejection of transplanted organs, new applications involving mediation of the effects of INTERLEUKINS and other CYTOKINES are emerging. (See all compounds classified as Immunosuppressive Agents.)
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DOSAGE - CREAM;TOPICAL - 0.025% **Federal Reg...DOSAGE - CREAM;TOPICAL - 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 11601
DOSAGE - CREAM;TOPICAL - 0.1% **Federal Regis...DOSAGE - CREAM;TOPICAL - 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 11601
DOSAGE - INJECTABLE;INJECTION - 10MG/ML
USFDA APPLICATION NUMBER - 12041
DOSAGE - SPRAY;TOPICAL - 0.147MG/GM **Federal...DOSAGE - SPRAY;TOPICAL - 0.147MG/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 12104
DOSAGE - INJECTABLE;INJECTION - 40MG/ML
USFDA APPLICATION NUMBER - 14901
DOSAGE - INJECTABLE;INJECTION - 80MG/ML
USFDA APPLICATION NUMBER - 14901
DOSAGE - SPRAY, METERED;NASAL - 0.055MG/SPRAY
USFDA APPLICATION NUMBER - 20468
DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;INT...DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR - 32MG/VIAL
USFDA APPLICATION NUMBER - 208845
DOSAGE - CREAM;TOPICAL - 0.025%
USFDA APPLICATION NUMBER - 85692
DOSAGE - CREAM;TOPICAL - 0.1%
USFDA APPLICATION NUMBER - 85692
DOSAGE - CREAM;TOPICAL - 0.5%
USFDA APPLICATION NUMBER - 85692
DOSAGE - OINTMENT;TOPICAL - 0.025%
USFDA APPLICATION NUMBER - 87385
DOSAGE - OINTMENT;TOPICAL - 0.1%
USFDA APPLICATION NUMBER - 87385
DOSAGE - OINTMENT;TOPICAL - 0.5%
USFDA APPLICATION NUMBER - 87385
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PharmaCompass offers a list of Triamcinolone Acetonide 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 Triamcinolone Acetonide manufacturer or Triamcinolone Acetonide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Triamcinolone Acetonide manufacturer or Triamcinolone Acetonide supplier.
PharmaCompass also assists you with knowing the Triamcinolone Acetonide API Price utilized in the formulation of products. Triamcinolone Acetonide API Price is not always fixed or binding as the Triamcinolone Acetonide Price is obtained through a variety of data sources. The Triamcinolone Acetonide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Oracort manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oracort, including repackagers and relabelers. The FDA regulates Oracort manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oracort 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 Oracort manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oracort supplier is an individual or a company that provides Oracort active pharmaceutical ingredient (API) or Oracort finished formulations upon request. The Oracort suppliers may include Oracort API manufacturers, exporters, distributors and traders.
click here to find a list of Oracort suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oracort DMF (Drug Master File) is a document detailing the whole manufacturing process of Oracort active pharmaceutical ingredient (API) in detail. Different forms of Oracort DMFs exist exist since differing nations have different regulations, such as Oracort USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oracort DMF submitted to regulatory agencies in the US is known as a USDMF. Oracort USDMF includes data on Oracort's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oracort USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oracort 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 Oracort Drug Master File in Japan (Oracort JDMF) empowers Oracort 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 Oracort JDMF during the approval evaluation for pharmaceutical products. At the time of Oracort 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 Oracort 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 Oracort Drug Master File in Korea (Oracort KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oracort. The MFDS reviews the Oracort KDMF as part of the drug registration process and uses the information provided in the Oracort KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oracort 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 Oracort API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oracort suppliers with KDMF on PharmaCompass.
A Oracort CEP of the European Pharmacopoeia monograph is often referred to as a Oracort Certificate of Suitability (COS). The purpose of a Oracort CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oracort EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oracort to their clients by showing that a Oracort CEP has been issued for it. The manufacturer submits a Oracort CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oracort CEP holder for the record. Additionally, the data presented in the Oracort CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oracort DMF.
A Oracort CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oracort 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 Oracort suppliers with CEP (COS) on PharmaCompass.
A Oracort written confirmation (Oracort WC) is an official document issued by a regulatory agency to a Oracort manufacturer, verifying that the manufacturing facility of a Oracort active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oracort APIs or Oracort finished pharmaceutical products to another nation, regulatory agencies frequently require a Oracort WC (written confirmation) as part of the regulatory process.
click here to find a list of Oracort 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 Oracort as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oracort 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 Oracort 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 Oracort and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oracort NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oracort suppliers with NDC on PharmaCompass.
Oracort 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 Oracort 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 Oracort GMP manufacturer or Oracort GMP API supplier for your needs.
A Oracort CoA (Certificate of Analysis) is a formal document that attests to Oracort's compliance with Oracort specifications and serves as a tool for batch-level quality control.
Oracort CoA mostly includes findings from lab analyses of a specific batch. For each Oracort 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.
Oracort may be tested according to a variety of international standards, such as European Pharmacopoeia (Oracort EP), Oracort JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oracort USP).
