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Chemistry

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Also known as: 76-25-5, Azmacort, Nasacort, Aristoderm, Aristogel, Vetalog
Molecular Formula
C24H31FO6
Molecular Weight
434.5  g/mol
InChI Key
YNDXUCZADRHECN-JNQJZLCISA-N
FDA UNII
F446C597KA

Triamcinolone Acetonide
An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.
Triamcinolone acetonide is a Corticosteroid. The mechanism of action of triamcinolone acetonide is as a Corticosteroid Hormone Receptor Agonist.
1 2D Structure

Triamcinolone Acetonide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1S,2S,4R,8S,9S,11S,12R,13S)-12-fluoro-11-hydroxy-8-(2-hydroxyacetyl)-6,6,9,13-tetramethyl-5,7-dioxapentacyclo[10.8.0.02,9.04,8.013,18]icosa-14,17-dien-16-one
2.1.2 InChI
InChI=1S/C24H31FO6/c1-20(2)30-19-10-16-15-6-5-13-9-14(27)7-8-21(13,3)23(15,25)17(28)11-22(16,4)24(19,31-20)18(29)12-26/h7-9,15-17,19,26,28H,5-6,10-12H2,1-4H3/t15-,16-,17-,19+,21-,22-,23-,24+/m0/s1
2.1.3 InChI Key
YNDXUCZADRHECN-JNQJZLCISA-N
2.1.4 Canonical SMILES
CC1(OC2CC3C4CCC5=CC(=O)C=CC5(C4(C(CC3(C2(O1)C(=O)CO)C)O)F)C)C
2.1.5 Isomeric SMILES
C[C@]12C[C@@H]([C@]3([C@H]([C@@H]1C[C@@H]4[C@]2(OC(O4)(C)C)C(=O)CO)CCC5=CC(=O)C=C[C@@]53C)F)O
2.2 Other Identifiers
2.2.1 UNII
F446C597KA
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Acetonide, Triamcinolone

2. Azmacort

3. Cinonide

4. Kenacort A

5. Kenalog

6. Kenalog 40

7. Tricort 40

8. Tricort-40

9. Tricort40

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 434.5 g/mol
Molecular Formula C24H31FO6
XLogP32.5
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count7
Rotatable Bond Count2
Exact Mass434.21046687 g/mol
Monoisotopic Mass434.21046687 g/mol
Topological Polar Surface Area93.1 Ų
Heavy Atom Count31
Formal Charge0
Complexity925
Isotope Atom Count0
Defined Atom Stereocenter Count8
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 10  
Drug NameKenalog-10
Drug LabelKenalog-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 IngredientTriamcinolone acetonide
Dosage FormInjectable
RouteInjection
Strength10mg/ml
Market StatusPrescription
CompanyApothecon

2 of 10  
Drug NameKenalog-40
Drug LabelKenalog-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 IngredientTriamcinolone acetonide
Dosage FormInjectable
RouteInjection
Strength40mg/ml
Market StatusPrescription
CompanyApothecon

3 of 10  
Drug NameTriamcinolone acetonide
Drug LabelTriamcinolone 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 IngredientTriamcinolone acetonide
Dosage FormOintment; Spray, metered; Paste; Cream; Lotion
RouteDental; Nasal; Topical
Strength0.5%; 0.055mg/spray; 0.1%; 0.025%
Market StatusPrescription
CompanyWockhardt; Taro; Lyne; Fougera Pharms; Teva Pharms; Versapharm; Vintage; Perrigo New York; Wockhardt Eu Operatn

4 of 10  
Drug NameTriamcinolone acetonide in absorbase
Drug LabelTRIESENCE (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 IngredientTriamcinolone acetonide
Dosage FormOintment
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyCarolina Medcl

5 of 10  
Drug NameTriesence
Active IngredientTriamcinolone acetonide
Dosage FormInjectable
RouteIntravitreal; suspension
Strength40mg/ml (40mg/ml); 40mgml
Market StatusPrescription
CompanyAlcon; Alcon Res

6 of 10  
Drug NameKenalog-10
Drug LabelKenalog-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 IngredientTriamcinolone acetonide
Dosage FormInjectable
RouteInjection
Strength10mg/ml
Market StatusPrescription
CompanyApothecon

7 of 10  
Drug NameKenalog-40
Drug LabelKenalog-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 IngredientTriamcinolone acetonide
Dosage FormInjectable
RouteInjection
Strength40mg/ml
Market StatusPrescription
CompanyApothecon

8 of 10  
Drug NameTriamcinolone acetonide
Drug LabelTriamcinolone 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 IngredientTriamcinolone acetonide
Dosage FormOintment; Spray, metered; Paste; Cream; Lotion
RouteDental; Nasal; Topical
Strength0.5%; 0.055mg/spray; 0.1%; 0.025%
Market StatusPrescription
CompanyWockhardt; Taro; Lyne; Fougera Pharms; Teva Pharms; Versapharm; Vintage; Perrigo New York; Wockhardt Eu Operatn

9 of 10  
Drug NameTriamcinolone acetonide in absorbase
Drug LabelTRIESENCE (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 IngredientTriamcinolone acetonide
Dosage FormOintment
RouteTopical
Strength0.05%
Market StatusPrescription
CompanyCarolina Medcl

10 of 10  
Drug NameTriesence
Active IngredientTriamcinolone acetonide
Dosage FormInjectable
RouteIntravitreal; suspension
Strength40mg/ml (40mg/ml); 40mgml
Market StatusPrescription
CompanyAlcon; Alcon Res

4.2 Drug Indication

Visualisation during vitrectomy


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

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.)


5.2 FDA Pharmacological Classification
5.2.1 Active Moiety
TRIAMCINOLONE ACETONIDE
5.2.2 FDA UNII
F446C597KA
5.2.3 Pharmacological Classes
Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]

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01-Jan-2022
30-Jun-2025
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DRUG PRODUCT COMPOSITIONS

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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

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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

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DOSAGE - INJECTABLE;INJECTION - 10MG/ML

USFDA APPLICATION NUMBER - 12041

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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

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DOSAGE - INJECTABLE;INJECTION - 40MG/ML

USFDA APPLICATION NUMBER - 14901

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DOSAGE - INJECTABLE;INJECTION - 80MG/ML

USFDA APPLICATION NUMBER - 14901

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DOSAGE - SPRAY, METERED;NASAL - 0.055MG/SPRAY

USFDA APPLICATION NUMBER - 20468

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DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;INT...DOSAGE - FOR SUSPENSION, EXTENDED RELEASE;INTRA-ARTICULAR - 32MG/VIAL

USFDA APPLICATION NUMBER - 208845

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DOSAGE - CREAM;TOPICAL - 0.025%

USFDA APPLICATION NUMBER - 85692

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DOSAGE - CREAM;TOPICAL - 0.1%

USFDA APPLICATION NUMBER - 85692

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DOSAGE - CREAM;TOPICAL - 0.5%

USFDA APPLICATION NUMBER - 85692

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DOSAGE - OINTMENT;TOPICAL - 0.025%

USFDA APPLICATION NUMBER - 87385

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DOSAGE - OINTMENT;TOPICAL - 0.1%

USFDA APPLICATION NUMBER - 87385

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DOSAGE - OINTMENT;TOPICAL - 0.5%

USFDA APPLICATION NUMBER - 87385

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ABOUT THIS PAGE

Looking for 76-25-5 / Triamcinolone Acetonide API manufacturers, exporters & distributors?

Triamcinolone Acetonide manufacturers, exporters & distributors 1

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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.

API | Excipient name

Triamcinolone Acetonide

Synonyms

76-25-5, Azmacort, Nasacort, Aristoderm, Aristogel, Vetalog

Cas Number

76-25-5

Unique Ingredient Identifier (UNII)

F446C597KA

About Triamcinolone Acetonide

An esterified form of TRIAMCINOLONE. It is an anti-inflammatory glucocorticoid used topically in the treatment of various skin disorders. Intralesional, intramuscular, and intra-articular injections are also administered under certain conditions.

Oracort Manufacturers

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.

Oracort Suppliers

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.

Oracort USDMF

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.

Oracort JDMF

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.

Oracort KDMF

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.

Oracort CEP

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.

Oracort WC

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.

Oracort NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Oracort API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Oracort CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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