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Chemistry

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Also known as: 50-24-8, Metacortandralone, Hydroretrocortine, Predonine, Delta-cortef, Deltacortril
Molecular Formula
C21H28O5
Molecular Weight
360.4  g/mol
InChI Key
OIGNJSKKLXVSLS-VWUMJDOOSA-N
FDA UNII
9PHQ9Y1OLM

Prednisolone
A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.
Prednisolone is a Corticosteroid. The mechanism of action of prednisolone is as a Corticosteroid Hormone Receptor Agonist.
1 2D Structure

Prednisolone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(8S,9S,10R,11S,13S,14S,17R)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthren-3-one
2.1.2 InChI
InChI=1S/C21H28O5/c1-19-7-5-13(23)9-12(19)3-4-14-15-6-8-21(26,17(25)11-22)20(15,2)10-16(24)18(14)19/h5,7,9,14-16,18,22,24,26H,3-4,6,8,10-11H2,1-2H3/t14-,15-,16-,18+,19-,20-,21-/m0/s1
2.1.3 InChI Key
OIGNJSKKLXVSLS-VWUMJDOOSA-N
2.1.4 Canonical SMILES
CC12CC(C3C(C1CCC2(C(=O)CO)O)CCC4=CC(=O)C=CC34C)O
2.1.5 Isomeric SMILES
C[C@]12C[C@@H]([C@H]3[C@H]([C@@H]1CC[C@@]2(C(=O)CO)O)CCC4=CC(=O)C=C[C@]34C)O
2.2 Other Identifiers
2.2.1 UNII
9PHQ9Y1OLM
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Di Adreson F

2. Di-adreson-f

3. Diadresonf

4. Predate

5. Predonine

2.3.2 Depositor-Supplied Synonyms

1. 50-24-8

2. Metacortandralone

3. Hydroretrocortine

4. Predonine

5. Delta-cortef

6. Deltacortril

7. Meticortelone

8. Deltahydrocortisone

9. Codelcortone

10. Cortalone

11. Prenolone

12. Sterane

13. Hydroretrocortin

14. Meti-derm

15. Prdl

16. Deltacortenol

17. Hydrodeltalone

18. Hydrodeltisone

19. Cotogesic

20. Decaprednil

21. Delcortol

22. Deltisilone

23. Dicortol

24. Donisolone

25. Dydeltrone

26. Erbacort

27. Erbasona

28. Estilsona

29. Fernisolone

30. Hydeltra

31. Hydeltrone

32. Lentosone

33. Paracortol

34. Paracotol

35. Precortancyl

36. Precortilon

37. Precortisyl

38. Prednelan

39. Prednicen

40. Predniliderm

41. Predonin

42. Rolisone

43. Scherisolon

44. Sterolone

45. Cordrol

46. Prednis

47. Prelone

48. Steran

49. Ulacort

50. Fernisolone P

51. Hostacortin H

52. Ultracorten H

53. Ultracortene-h

54. Delta-stab

55. Predne-dome

56. Decortin H

57. Co-hydeltra

58. Eazolin D

59. Di-adreson F

60. Delta F

61. Derpo Pd

62. 1-dehydrohydrocortisone

63. Solone

64. Delta(1)-hydrocortisone

65. Fernisolone-p

66. Delta(1)-dehydrocortisol

67. Delta-ef-cortelan

68. Dexa-cortidelt Hostacortin H

69. 1,2-dehydrohydrocortisone

70. Panafcortelone

71. Prednisolona

72. Prednisolonum

73. Prednisolonum [inn-latin]

74. Prednisolona [inn-spanish]

75. 1,4-pregnadiene-11beta,17alpha,21-triol-3,20-dione

76. (11beta)-11,17,21-trihydroxypregna-1,4-diene-3,20-dione

77. Ultracortene-hydrogen

78. Delta(1)-dehydrohydrocortisone

79. 1,4-pregnadiene-3,20-dione-11beta,17alpha,21-triol

80. 3,20-dioxo-11beta,17alpha,21-trihydroxy-1,4-pregnadiene

81. 11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione

82. K 1557

83. .delta.1-cortisol

84. Nsc-9120

85. Nsc-9900

86. .delta.1-hydrocortisone

87. 9phq9y1olm

88. (8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-7,8,9,11,12,14,15,16-octahydro-6h-cyclopenta[a]phenanthren-3-one

89. .delta.1-dehydrocortisol

90. Chembl131

91. Chebi:8378

92. .delta.1-dehydrohydrocortisone

93. 11beta,17alpha,21-trihydroxypregna-1,4-diene-3,20-dione

94. Predniretard

95. Poly-pred

96. .delta.-cortef

97. Neo-delta-cortef

98. .delta.-stab

99. Component Of Ataraxoid

100. Cotolone

101. Pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-, (11b)-

102. Dsstox_cid_1184

103. Component Of K-predne-dome

104. Dsstox_rid_75996

105. Dsstox_gsid_21184

106. (1s,2r,10s,11s,14r,15s,17s)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-dien-5-one

107. (8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-3-one

108. Delta(1)-cortisol

109. Deltasolone

110. Klismacort

111. Supercortisol

112. Delta(sup 1)-cortisol

113. Bubbli-pred

114. Delta(sup 1)-hydrocortisone

115. Delta(sup 1)-dehydrocortisol

116. Smr000718761

117. Ccris 980

118. Prednisolone [inn:ban:jan]

119. Hsdb 3385

120. Delta(sup 1)-dehydrohydrocortisone

121. Mls002638110

122. Nsc 9120

123. Pregna-1,20-dione, 11.beta.,17,21-trihydroxy-

124. Einecs 200-021-7

125. Unii-9phq9y1olm

126. Mfcd00003649

127. Predisolone Sodium Phosphate

128. Brn 1354103

129. Prednisolon

130. Preflam

131. Pregna-1,20-dione, 11,17,21-trihydroxy-, (11.beta.)-

132. Cas-50-24-8

133. Pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-

134. Ncgc00094764-01

135. Prednisolone Powder

136. Delta-hydrocortisone

137. Prestwick_404

138. Delta-dehydrocortisol

139. Delta.1-cortisol

140. Aprednislon

141. Equisolon

142. Vetsolone

143. Delta-cortef (tn)

144. 11-beta,17,21-trihydroxypregna-1,4-diene-3,20-dione

145. T-pred (salt/mix)

146. 1,4-pregnadien-11-beta,17-alpha,21-triol-3,20-dione

147. 1,4-pregnadiene-11-beta,17-alpha,21-triol-3,20-dione

148. 1,4-pregnadiene-3,20-dione-11-beta,17-alpha,21-triol

149. Pregna-1,4-diene-3,20-dione, 11beta,17,21-trihydroxy-

150. Prednisolone, >=99%

151. Prestwick0_000274

152. Prestwick1_000274

153. Prestwick2_000274

154. Prestwick3_000274

155. Delta-dehydrohydrocortisone

156. Prednisolone [ep]

157. Prednisolone [mi]

158. (+)-prednisolone

159. Pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-, (11.beta.)-

160. Prednisolone [inn]

161. Prednisolone [jan]

162. Ec 200-021-7

163. Prednisolone [hsdb]

164. Schembl3233

165. K-predne-dome (salt/mix)

166. Prednisolone [vandf]

167. Prednisolone Anhydrous

168. .delta.(sup 1)-cortisol

169. Bspbio_000148

170. Prednisolone [mart.]

171. (11alpha)-11,17,21-trihydroxypregna-1,4-diene-3,20-dione

172. 4-08-00-03467 (beilstein Handbook Reference)

173. Mls001304083

174. Mls002154250

175. Mls002207037

176. Mls002548883

177. Prednisolone [usp-rs]

178. Prednisolone [who-dd]

179. Prednisolone [who-ip]

180. Spbio_002367

181. Bpbio1_000164

182. Gtpl2866

183. Dtxsid9021184

184. .delta.(sup 1)-hydrocortisone

185. Bdbm19190

186. Prednisolone (jp17/usp/inn)

187. Nsc9120

188. Nsc9900

189. Prednisolone [green Book]

190. .delta.(sup 1)-dehydrocortisol

191. Hms1568h10

192. Hms2090j05

193. Hms2095h10

194. Hms2230p10

195. Hms3259e09

196. Hms3712h10

197. Prednisolone [orange Book]

198. Prednisolone [ep Monograph]

199. Prednisone Impurity B [ep]

200. Bcp09053

201. Zinc3833821

202. Prednisolone [usp Monograph]

203. Tox21_111327

204. Tox21_201673

205. Tox21_302987

206. Lmst02030179

207. Prednisolonum [who-ip Latin]

208. S1737

209. .delta.(sup 1)-dehydrohydrocortisone

210. Akos015894935

211. Tox21_111327_1

212. Ac-1773

213. Ccg-220274

214. Db00860

215. Nc00473

216. Ncgc00179649-01

217. Ncgc00179649-02

218. Ncgc00179649-03

219. Ncgc00179649-04

220. Ncgc00179649-06

221. Ncgc00256577-01

222. Ncgc00259222-01

223. As-13665

224. Hy-17463

225. Prednisolone 1000 Microg/ml In Methanol

226. Prednisolone (ema Epar: Veterinary)

227. Prednisolone 100 Microg/ml In Acetonitrile

228. P0637

229. En300-53017

230. Prednicarbate Impurity A [ep Impurity]

231. C07369

232. D00472

233. D91990

234. Hydrocortisone Impurity A [ep Impurity]

235. Prednisolone, Vetranal(tm), Analytical Standard

236. 003p649

237. A929791

238. Chloroptic-p S.o.p. Component Prednisolone

239. Methylprednisolone Impurity K [ep Impurity]

240. Sr-01000837502

241. Q-201616

242. Sr-01000837502-2

243. 11b,17,21-trihydroxypregna-1,4-diene-3,20-dione

244. Brd-k98039984-001-03-0

245. Brd-k98039984-001-06-3

246. Prednisolone Acetate Impurity B [ep Impurity]

247. Prednisolone Component Of Chloroptic-p S.o.p.

248. Q11426176

249. 11beta,17,21-trihydroxy-1,4-pregnadiene-3,20-dione

250. Delta-1-cortisol; Prednicarbate Ep Imp A; Supercortisol

251. Prednisolone, British Pharmacopoeia (bp) Assay Standard

252. Z1245633279

253. 11-.beta.,17,21-trihydroxypregna-1,4-diene-3,20-dione

254. 1,4-pregnadien-11-.beta.,17-.alpha.,21-triol-3,20-dione

255. 1,4-pregnadiene-11-.beta.,17-.alpha.,21-triol-3,20-dione

256. 1,4-pregnadiene-3,20-dione-11-.beta.,17-.alpha.,21-triol

257. Prednisolone, European Pharmacopoeia (ep) Reference Standard

258. Pregna-1,4-diene-3,20-dione, 11.beta.,17,21-trihydroxy-

259. 11,17,21-trihydroxypregna-1,4-diene-3,20-dione, (11.beta.)-

260. 11-.beta.,17-.alpha.,21-trihydroxy-1,4-pregnadiene-3,20-dione

261. 11-.beta.,17-.alpha.,21-trihydroxypregna-1,4-diene-3,20-dione

262. 11.beta.,17,21-trihydroxypregna-1,4-diene-3,20-dione

263. 11.beta.,17,21-trihydroxypregna-1,4-diene-3,20-dione.

264. 11.beta.,17.alpha.,21-trihydroxypregna-1,4-diene-3,20-dione

265. Prednisolone, United States Pharmacopeia (usp) Reference Standard

266. Prednisolone For Peak Identification, European Pharmacopoeia (ep) Reference Standard

267. Prednisolone For System Suitability, European Pharmacopoeia (ep) Reference Standard

268. Prednisolone, Pharmaceutical Secondary Standard; Certified Reference Material

269. Pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-, (11.beta)-

270. (1s,2r,10s,11s,14r,15s,17s)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyltetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-3,6-dien-5-one

271. (8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-8,10,13-trimethyl-3-oxo-6,7,9,11,12,14,15,16-octahydrocyclopenta[a]phenanthrene-17-carboxylic Acid;prednisolone

272. 8056-11-9

273. Prednisolone Solution, 100 Mug/ml In Acetonitrile, Ampule Of 1 Ml, Certified Reference Material

274. Tua

2.3.3 Other Synonyms

1. Hydeltra-t.b.a.

2. Prednisolone Tebutate

3. Prednisolone Trimethylacetate

4. Prednisolone Pivalate

5. Sintisone

6. Prednisolone Steaglate

7. Prednisolone Succinate

8. Prednisolone Sodium Succinate

9. Prednisolone Hemisuccinate

10. Prednisolone Hydrogen Succinate

2.4 Create Date
2005-03-26
3 Chemical and Physical Properties
Molecular Weight 360.4 g/mol
Molecular Formula C21H28O5
XLogP31.6
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count5
Rotatable Bond Count2
Exact Mass360.19367399 g/mol
Monoisotopic Mass360.19367399 g/mol
Topological Polar Surface Area94.8 Ų
Heavy Atom Count26
Formal Charge0
Complexity724
Isotope Atom Count0
Defined Atom Stereocenter Count7
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 12  
Drug NameBlephamide
PubMed HealthSulfacetamide/Prednisolone (Into the eye)
Drug ClassesSulfonamide/Corticosteroid Combination
Active Ingredientsulfacetamide sodium; Prednisolone acetate
Dosage FormSuspension
RouteOphthalmic
Strength0.2%; 10%
Market StatusPrescription
CompanyAllergan

2 of 12  
Drug NameOrapred
PubMed HealthPrednisolone (By mouth)
Drug ClassesEndocrine-Metabolic Agent, Immune Suppreant
Active IngredientPrednisolone sodium phosphate
Dosage FormSolution
RouteOral
Strengtheq 15mg base/5ml
Market StatusPrescription
CompanyConcordia Pharms

3 of 12  
Drug NamePediapred
PubMed HealthPrednisolone
Drug ClassesEndocrine-Metabolic Agent, Immune Suppreant, Ophthalmologic Agent
Active IngredientPrednisolone sodium phosphate
Dosage FormSolution
RouteOral
Strengtheq 5mg base/5ml
Market StatusPrescription
CompanySeton Pharm

4 of 12  
Drug NamePred-g
Active Ingredientprednisolone acetate; Gentamicin sulfate
Dosage FormOintment; Suspension/drops
RouteOphthalmic
Strength1%; 0.6%; eq 0.3% base
Market StatusPrescription
CompanyAllergan

5 of 12  
Drug NamePrednisolone
Drug LabelDESCRIPTIONPrednisolone Oral Solution contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a...
Active IngredientPrednisolone
Dosage FormTablet; Syrup
RouteOral
Strength15mg/5ml; 5mg
Market StatusPrescription
CompanyWockhardt; Alpharma; Pharm Aoc; Watson Labs; Hi Tech Pharma; Vintage

6 of 12  
Drug NamePrelone
Active IngredientPrednisolone
Dosage FormSyrup
RouteOral
Strength15mg/5ml
Market StatusPrescription
CompanyTeva

7 of 12  
Drug NameBlephamide
PubMed HealthSulfacetamide/Prednisolone (Into the eye)
Drug ClassesSulfonamide/Corticosteroid Combination
Active Ingredientsulfacetamide sodium; Prednisolone acetate
Dosage FormSuspension
RouteOphthalmic
Strength0.2%; 10%
Market StatusPrescription
CompanyAllergan

8 of 12  
Drug NameOrapred
PubMed HealthPrednisolone (By mouth)
Drug ClassesEndocrine-Metabolic Agent, Immune Suppreant
Active IngredientPrednisolone sodium phosphate
Dosage FormSolution
RouteOral
Strengtheq 15mg base/5ml
Market StatusPrescription
CompanyConcordia Pharms

9 of 12  
Drug NamePediapred
PubMed HealthPrednisolone
Drug ClassesEndocrine-Metabolic Agent, Immune Suppreant, Ophthalmologic Agent
Active IngredientPrednisolone sodium phosphate
Dosage FormSolution
RouteOral
Strengtheq 5mg base/5ml
Market StatusPrescription
CompanySeton Pharm

10 of 12  
Drug NamePred-g
Active Ingredientprednisolone acetate; Gentamicin sulfate
Dosage FormOintment; Suspension/drops
RouteOphthalmic
Strength1%; 0.6%; eq 0.3% base
Market StatusPrescription
CompanyAllergan

11 of 12  
Drug NamePrednisolone
Drug LabelDESCRIPTIONPrednisolone Oral Solution contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a...
Active IngredientPrednisolone
Dosage FormTablet; Syrup
RouteOral
Strength15mg/5ml; 5mg
Market StatusPrescription
CompanyWockhardt; Alpharma; Pharm Aoc; Watson Labs; Hi Tech Pharma; Vintage

12 of 12  
Drug NamePrelone
Active IngredientPrednisolone
Dosage FormSyrup
RouteOral
Strength15mg/5ml
Market StatusPrescription
CompanyTeva

4.2 Therapeutic Uses

Anti-Inflammatory Agents, Steroidal; Antineoplastic Agents, Hormonal; Glucocorticoids, Synthetic

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


Ophthalmic corticosteroids are indicated in the treatment of corticosteroid-responsive allergic and inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe. /Corticosteroids (Ophthalmic); Included in US product labeling/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 906


VET: Hormonal therapy for neoplasia commonly involves the use of glucocorticoids. Direct antitumor effects are related to their lympholytic properties; glucocorticoids can inhibit mitosis, RNA synthesis, and protein synthesis in sensitive lymphocytes. Glucocorticoids are considered cell-cycle nonspecific and are often used in chemotherapeutic protocols after induction by another agent. Prednisolone /is/ commonly used to treat lymphoreticular neoplasms in combination with other drugs. Because /it/ readily enters the CSF, ... prednisolone /is/ especially useful in treatment of leukemias and lymphomas of the CNS.

Kahn, C.M. (Ed.); The Merck Veterinary Manual 9th ed. Merck & Co. Whitehouse Station, NJ. 2005, p. 2150


Indicated in a wide range of endocrine, rheumatic, allergic, dermatologic, respiratory, hematologic, neoplastic, and other disorders.

Hussar, D.A. (ed.). Modell's Drugs in Current Use and New Drugs. 38th ed. New York, NY: Springer Publishing Co., 1992., p. 135


For more Therapeutic Uses (Complete) data for PREDNISOLONE (28 total), please visit the HSDB record page.


4.3 Drug Warning

VET: IT OFTEN MAY BE CONTRAINDICATED IN CONGESTIVE HEART FAILURE, DIABETES OR OSTEOPOROSIS. EXCEPT FOR EMERGENCY LIFE SAVING USE, IT SHOULD BE OMITTED IN TUBERCULOSIS, CHRONIC NEPHRITIS, CUSHINGOID SYNDROMES, & PEPTIC ULCER CASES.

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 479


Side effects and compliance were examined in 63 pediatric patients (ages 10 mo-14 yr) with acute asthma who received an oral dose of 1-2 mg/kg prednisolone (Solone; Panafcortelone) as a whole or crushed tablet or in liquid form for 7 days. Up to 44% of patients either refused to take or vomited the drug on the first day. Improved acceptability of prednisolone occurred with time, but prescribing practices indicated short-term treatment of 1 to 4 days was common. Abdominal pain and mood changes occurred in 19% and 80% of patients, respectively, at some stage of the study period. It was concluded that oral prednisolone is poorly tolerated in pediatric patients and its use may lead to suboptimal therapy.

Dawson KP et al; Aust J Hosp Pharm 22 (Aug): 278-82 (1992)


Glucocorticoid use in children is not only associated with the side effects which are seen in adults, but also with severe adverse effects on statural growth. As little as 2.5-5.0 mg prednisolone/day can cause a retardation in statural growth. A direct relationship exists between the dose of glucocorticoid used and statural growth. The use of knemometry, a sensitive technique for measuring the growth of long bones in children has increased the accuracy of growth rate measurements. Many factors, such as disease process, sex, daily vs alternate day therapy, ethnic variations or whether the patient has been immobilized must be considered when evaluating the effects on stature of a particular glucocorticoid.

PMID:8495277 Avioli LV; Br J Rheumatol 32 (Suppl 2): 27-30 (1993)


RESULTS FROM CONTROLLED TRIAL, INDICATE THAT PREDNISOLONE TREATMENT IS NOT BENEFICIAL & CAN BE DETRIMENTAL IN ACUTE NEUROPATHY OF UNDETERMINED ETIOLOGY.

PMID:80682 HUGHES RAC ET AL; LANCET 2 (OCT 7): 750 (1978)


For more Drug Warnings (Complete) data for PREDNISOLONE (48 total), please visit the HSDB record page.


4.4 Drug Indication

Prednisolone is indicated to treat endocrine, rheumatic, and hematologic disorders; collagen, dermatologic, ophthalmic, respiratory, and gastrointestinal diseases; allergic and edematous states; and other conditions like tuberculous meningitis.


FDA Label


Alleviation of inflammatory and clinical parameters associated with recurrent airway obstruction (RAO) in horses, in combination with environmental control.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Corticosteroids bind to the glucocorticoid receptor, inhibiting pro-inflammatory signals, and promoting anti-inflammatory signals. Prednisolone has a short duration of action as the half life is 2.1-3.5 hours. Corticosteroids have a wide therapeutic window as patients make require doses that are multiples of what the body naturally produces. Patients taking corticosteroids should be counselled regarding the risk of hypothalamic-pituitary-adrenal axis suppression and increased susceptibility to infections.


5.2 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.)


Antineoplastic Agents, Hormonal

Antineoplastic agents that are used to treat hormone-sensitive tumors. Hormone-sensitive tumors may be hormone-dependent, hormone-responsive, or both. A hormone-dependent tumor regresses on removal of the hormonal stimulus, by surgery or pharmacological block. Hormone-responsive tumors may regress when pharmacologic amounts of hormones are administered regardless of whether previous signs of hormone sensitivity were observed. The major hormone-responsive cancers include carcinomas of the breast, prostate, and endometrium; lymphomas; and certain leukemias. (From AMA Drug Evaluations Annual 1994, p2079) (See all compounds classified as Antineoplastic Agents, Hormonal.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
PREDNISOLONE
5.3.2 FDA UNII
9PHQ9Y1OLM
5.3.3 Pharmacological Classes
Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]
5.4 ATC Code

QH02AB06


S01BA04

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


A - Alimentary tract and metabolism

A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents

A07E - Intestinal antiinflammatory agents

A07EA - Corticosteroids acting locally

A07EA01 - Prednisolone


C - Cardiovascular system

C05 - Vasoprotectives

C05A - Agents for treatment of hemorrhoids and anal fissures for topical use

C05AA - Corticosteroids

C05AA04 - Prednisolone


D - Dermatologicals

D07 - Corticosteroids, dermatological preparations

D07A - Corticosteroids, plain

D07AA - Corticosteroids, weak (group i)

D07AA03 - Prednisolone


D - Dermatologicals

D07 - Corticosteroids, dermatological preparations

D07X - Corticosteroids, other combinations

D07XA - Corticosteroids, weak, other combinations

D07XA02 - Prednisolone


H - Systemic hormonal preparations, excl. sex hormones and insulins

H02 - Corticosteroids for systemic use

H02A - Corticosteroids for systemic use, plain

H02AB - Glucocorticoids

H02AB06 - Prednisolone


R - Respiratory system

R01 - Nasal preparations

R01A - Decongestants and other nasal preparations for topical use

R01AD - Corticosteroids

R01AD02 - Prednisolone


S - Sensory organs

S01 - Ophthalmologicals

S01B - Antiinflammatory agents

S01BA - Corticosteroids, plain

S01BA04 - Prednisolone


S - Sensory organs

S01 - Ophthalmologicals

S01C - Antiinflammatory agents and antiinfectives in combination

S01CB - Corticosteroids/antiinfectives/mydriatics in combination

S01CB02 - Prednisolone


S - Sensory organs

S02 - Otologicals

S02B - Corticosteroids

S02BA - Corticosteroids

S02BA03 - Prednisolone


S - Sensory organs

S03 - Ophthalmological and otological preparations

S03B - Corticosteroids

S03BA - Corticosteroids

S03BA02 - Prednisolone


5.5 Absorption, Distribution and Excretion

Absorption

Oral prednisolone reaches a Cmax of 113-1343ng/mL with a Tmax of 1.0-2.6 hours. Oral prednisolone is approximately 70% bioavailable.


Route of Elimination

Prednisolone is over 98% eliminated in urine.


Volume of Distribution

A 0.15mg/kg dose of prednisolone has a volume of distribution of 29.3L, while a 0.30mg/kg dose has a volume of distribution of 44.2L.


Clearance

A 0.15mg/kg dose of prednisolone has a clearance of 0.09L/kg/h, while a 0.30mg/kg dose has a clearance of 0.12L/kg/h.


A randomized crossover study was conducted to compare the pharmacokinetics and pharmacodynamics of 30 mg prednisolone in a plain oral tablet (Precortisyl) with those of an enteric coated tablet (Deltacortril) in 8 patients (ages 63-81 yr) with chronic obstructive pulmonary disease and in 8 healthy males (ages 22-44 yr). Although drug absorption was considerably slower from the enteric coated tablet, peak plasma levels and total area under the concn-time curve were equivalent for the formulations. Adrenal suppression was significantly less in volunteers after enteric coated than after plain tablets. This difference was not significant in patients. Plasma cortisol levels declined more slowly after enteric coated tablets in both groups. Blood glucose levels increased over 8 hr in both groups. It was concluded that in patients with chronic obstructive pulmonary disease, peak plasma levels and total area under the concn-time curve of plain and enteric coated prednisolone tablets are equivalent; enteric coated tablets result in a lag in the decline of plasma cortisol and, in volunteers, a less marked suppression of cortisol.

PMID:1524961 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1381435 Adair CG et al; Br J Clin Pharmacol 33 (5): 495-9 (1992)


The transfer of prednisolone to breast milk was studied in 3 nursing women (ages 28-37 yr) who received an intravenous injection of 50 mg prednisolone sodium phosphate (Hydeltrasol). Concn of prednisolone in milk declined more rapidly than in serum, but were similar to expected unbound serum levels. Milk levels ranged from about 15% to 40% of serum levels. The exchange between unbound drug in serum and breast milk appeared to be relatively rapid and bidirectional. An average of 0.025% (0.01-0.49%) of the prednisolone dose was recovered in milk. It was concluded that the transfer of prednisolone to breast milk does not appear to pose a clinically significant risk.

PMID:8453851 Greenberger PA et al; Clin Pharmacol Ther 53 (3): 324-8 (1993)


The pharmacokinetics of prednisolone after oral and intravenous administration of 10 and 20 mg have been studied. Serum protein binding of prednisolone was also measured after the iv injections. The bioavailability after oral administration was 84.5% after 10 mg and 77.6% after 20 mg (p>0.05). Dose dependent pharmacokinetics were found, the VDss and Clt being significantly larger (p<0.01) after 20 mg iv than after 10 mg iv. The protein binding of prednisolone in all subjects was non-linear, and is the most likely cause of the dose dependent pharmacokinetics, as there was no dose dependent variation in elimination half-time.

PMID:6861855 Bergrem H et al; Eur J Clin Pharmacol 24 (3): 415-9 (1983)


Doses of 16, 32, 48 and 64 mg prednisolone were administered intravenously to normal volunteers who also received 100 prednisolone orally. Plasma prednisolone concentrations were estimated by quantitative thin layer chromatography. The bioavailability fraction was 1.063 +/- 0.154 (s.d.) indicating complete availability of prednisolone following oral administration. The mean T 1/2 over all doses were 4.11 +/- 0.97 (s.d.) hr and there was no evidence of a dose-related change in its value. The mean systemic clearance over all doses was 0.104 +/- 0.034 (s.d) L/hr/kg. There was no evidence of a dose-related change in clearance or in the apparent volume of distribution (overall mean 0.588 +/- 0.152 L/kg). The area under the plasma concentration-time curve was linearly related to dose. Plasma concentration-time curves normalised for dose were superimposable. It was concluded that over the dose range investigated, non-linear pharmacokinetic behavior had not been demonstrated in this group of normal volunteers.

PMID:7437263 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1430141 Al-Habet S, Rogers HJ; Br J Clin Pharmacol 10 (5): 503-8 (1980)


For more Absorption, Distribution and Excretion (Complete) data for PREDNISOLONE (13 total), please visit the HSDB record page.


5.6 Metabolism/Metabolites

Prednisolone can be reversibly metabolized to [prednisone] which is then metabolized to 17,21-dihydroxy-pregnan-1,4,6-trien-3,11,30-trione (M-XVII), 20-dihydro-prednisone (M-V), 6hydroxy-prednisone (M-XII), 6-hydroxy-prednisone (M-XIII), or 20-dihydro-prednisone (M-IV). 20-dihydro-prednisone is metabolized to 17,20,21-trihydroxy-5-pregn-1-en-3,11-dione(M-XVIII). Prednisolone is metabolized to 6-prednisolone (M-XI), 20-dihydro-prednisolone (M-III), 20-dihydro-prednisolone (M-II), 6hydroxy-prednisolone (M-VII), or 6hydroxy-prednisolone(M-VI). 6hydroxy-prednisolone is metabolized to 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-X). 6hydroxy-prednisolone is metabolized to 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-VIII), 6,11,17,20,21-pentahydroxypregnan-1,4-diene-3-one (M-IX), and 6,11,17,21-tetrahydroxy-5-pregn-1-en-3,20-dione (M-XIV). MVIII is metabolized to 6,11,17,20,21-pentahydroxy-5-pregn-1-en-3-one (M-XV) and then to MXIV, while MIX is metabolized to 6,11,17,20,21-pentahydroxy-5-pregn-1-en-3-one (M-XVI) and then to MXIV. These metabolites and their glucuronide conjugates are excreted predominantly in the urine.


Reduction of the 4,5 double bond can occur at both hepatic and extrahepatic sites and yields an inactive substance. Subsequent reduction of the 3-ketone substituent to a 3-hydroxyl to form tetrahydrocortisol has been demonstrated only in liver. Most of the ring a - reduced metabolites are enzymatically coupled through the 3-hydroxyl with sulfate or with glucuronic acid to form water soluble sulfate esters or glucuronides, and they are excreted as such.

Gilman, A.G., T.W. Rall, A.S. Nies and P. Taylor (eds.). Goodman and Gilman's The Pharmacological Basis of Therapeutics. 8th ed. New York, NY. Pergamon Press, 1990., p. 1446


Conjugated mostly in liver but also in kidney. /Human, oral/

American Society of Hospital Pharmacists. Data supplied on contract from American Hospital Formulary Service and other current ASHP sources., p. 1963


In the present study the metabolism of prednisolone in the isolated, perfused, dual recirculating human placental lobule was reexamined, using a perfusate based on tissue culture medium 199. Four metabolites were identified in both the maternal and fetal compartments in 6 hr perfusions by comparison of relative retention times measured by HPLC and capillary GC and of mass spectra recorded by capillary GC/MS with those of authentic reference standards. The steroids were derivatized as the MO-TMS ethers for mass spectral measurements. Analysis of samples from five perfusion experiments resulted in the following percentage conversions after 6 hr perfusion (mean + or - standard deviation, maternal and fetal perfusate, respectively): prednisone (49.1 + or - 7.8, 49.1 + or - 6.6), 20 alpha-dihydroprednisone (0.84 + or - 0.29, 0.81 + or - 0.35), 20 beta-dihydroprednisone (39.1 + or - 6.7, 39.2 + or - 5.9), 20 beta-dihydroprednisolone (6.8 + or - 2.7, 6.3 + or - 1.6) and unmetabolized prednisolone (4.1 + or - 1.8, 4.6 + or - 2.1). No evidence was found for metabolites formed by 6 beta-hydroxylation or cleavage of the C17-C20 bond.

PMID:2069869 Addison RS et al; J Steroid Biochem Mol Biol 39 (1): 83-90 (1991)


A randomized, four-way cross-over study was conducted in eight healthy male volunteers to determine the relative and absolute bioavailability of prednisone (PN) and prednisolone (PL). PN and PL were administered as single, oral 10-mg tablet doses and as 10-mg zero-order 0.5-hour intravenous infusions. Comparable mean PN and PL maximum plasma concentrations (Cmax), times for Cmax, areas under the plasma concentration-time curves (AUC), and apparent elimination rate constants between tablet treatments demonstrated that PN and PL tablets were bioequivalent. Absolute bioavailability (F) determinations based on plasma PL concentrations were independent of which IV treatment was used as reference and indicated complete systemic availability of PL from both PN and PL tablets. However, F based on plasma PN data was contradictory. Using IV PN as reference, approximately 70% systemic availability was observed from both tablets, whereas using IV PL as reference, systemic availability was greater than unity. PN and PL are model compounds that exemplify the difficulties involved in accurately determining the relative and absolute bioavailability of substances that undergo reversible metabolism.

PMID:3350994 Ferry JJ et al; J Clin Pharmacol 28(1):81-7 (1988)


Prednisone, prednisolone, and methylprednisolone are currently administered in association with cyclosporin A in the postoperative treatment of transplant patients. The aim of this work was to evaluate the effects of these corticosteroids on the expression of several forms of cytochromes p450, including p450 1A2, 2D6, 2E1, and 3A, and on cyclosporin A oxidase activity in human liver. For this purpose, human hepatocytes prepared from lobectomies were maintained in culture in a serum-free medium, in collagen-coated dishes, for 96-144 hr, in the absence or presence of 50-100 uM corticosteroids, rifampicin, or dexamethasone. To mimic more closely the current clinical protocol, hepatocyte cultures were also co-treated with corticosteroids and cyclosporin A or ketoconazole (a selective inhibitor of cytochromes p450 3A). Cyclosporin A oxidase activity, intracellular retention of cyclosporin A oxidized metabolites within hepatocytes, accumulation of cytochromes p450 proteins and corresponding messages, and de novo synthesis and half-lives of these cytochromes p450 were measured in parallel in these cultures. Our results, obtained from seven different hepatocyte cultures, showed that 1) dexamethasone and prednisone, but not prednisolone or methylprednisolone, were inducers of cytochrome p450 3A, at the level of protein and mRNA accumulation, as well as of cyclosporin A oxidase activity, known to be predominantly catalyzed by these cytochromes p450; 2) although corticosteroids are known to be metabolized in human liver, notably by cytochrome p450 3A, partial or total inhibition of this cytochromes p450 by cyclosporin or ketoconazole, respectively, did not affect the inducing efficiency of these molecules; 3) corticosteroids did not affect the half-life of cytochrome p450 3A or the accumulation of other forms of cytochromes p450, including 1A2, 2D6, and 2E1; 4) chronic treatment of cells with cyclosporin did not affect cytochrome p450 3A accumulation; 5) corticosteroids were all competitive inhibitors of cyclosporin A oxidase in human liver microsomes, with Ki values of 61 + or - 12, 125 + or - 25, 190 + or - 38, and 210 + or - 42 uM for dexamethasone, prednisolone, prednisone, and methylprednisolone, respectively; and 6) chronic treatment of cells with corticosteroids did not influence the excretion of oxidized metabolites of cyclosporin from the cells.

PMID:1614409 Pichard L et al; Mol Pharmacol 41 (6): 1047-55 (1992)


5.7 Biological Half-Life

Prednisolone has a plasma half life of 2.1-3.5 hours. This half life is shorter in children and longer in those with liver disease.


...Prednisolone (60 mg/sq m/day in three divided doses) was administered both orally and intravenously /to 23 children with acute lymphoblastic leukemia (ALL) (aged 2-15 years)/, and samples were obtained on several days during the initial 5 weeks of remission induction therapy. ...The median unbound clearance (32 L/hr/sq m) was lower, and the half-life (3.6 hr) longer than previously reported in childhood ALL.

PMID:12698270 Petersen KB et al; Cancer Chemother Pharmacol 51 (6): 465-73 (2003)


Doses of 16, 32, 48 and 64 mg prednisolone were administered intravenously to normal volunteers who also received 100 prednisolone orally. ...The mean T 1/2 over all doses were 4.11 +/- 0.97 (s.d.) hr and there was no evidence of a dose-related change in its value.

PMID:7437263 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1430141 Al-Habet S, Rogers HJ; Br J Clin Pharmacol 10 (5): 503-8 (1980)


5.8 Mechanism of Action

The short term effects of corticosteroids are decreased vasodilation and permeability of capillaries, as well as decreased leukocyte migration to sites of inflammation. Corticosteroids binding to the glucocorticoid receptor mediates changes in gene expression that lead to multiple downstream effects over hours to days. Glucocorticoids inhibit neutrophil apoptosis and demargination; they inhibit phospholipase A2, which decreases the formation of arachidonic acid derivatives; they inhibit NF-Kappa B and other inflammatory transcription factors; they promote anti-inflammatory genes like interleukin-10. Lower doses of corticosteroids provide an anti-inflammatory effect, while higher doses are immunosuppressive. High doses of glucocorticoids for an extended period bind to the mineralocorticoid receptor, raising sodium levels and decreasing potassium levels.


Although altered homeostatic regulation, including disturbance of 24-h rhythms, is often observed in the patients undergoing glucocorticoid therapy, the mechanisms underlying the disturbance remains poorly understood. We report here that chronic treatment with a synthetic glucocorticoid, prednisolone, can cause alteration of circadian clock function at molecular level. Treatment of cultured hepatic cells (HepG2) with prednisolone induced expression of Period1 (Per1), and the prednisolone treatment also attenuated the serum-induced oscillations in the expression of Period2 (Per2), Rev-erbalpha, and Bmal1 mRNA in HepG2 cells. Because the attenuation of clock gene oscillations was blocked by pretreating the cells with a Per1 antisense phosphothioate oligodeoxynucleotide, the extensive expression of Per1 induced by prednisolone may have resulted in the reduced amplitude of other clock gene oscillations. Continuous administration of prednisolone into mice constitutively increased the Per1 mRNA levels in liver and skeletal muscle, which seems to attenuate the oscillation in the expressions of Per2, Rev-erbalpha, and Bmal1. However, a single daily administration of prednisolone at the time of day corresponding to acrophase of endogenous glucocorticoid levels had little effect on the rhythmic expression of clock genes. These results suggest a possible pharmacological action by prednisolone on the core circadian oscillation mechanism and indicate the possibility that the alteration of clock function induced by prednisolone can be avoided by optimizing the dosing schedule.

PMID:16269518 Koyanagi S et al; Mol Endocrinol 20 (3): 573-83 (2006)


Glucocorticoids are capable of suppressing the inflammatory process through numerous pathways. They interact with specific intracellular receptor proteins in target tissues to alter the expression of corticosteroid-responsive genes. Glucocorticoid-specific receptors in the cell cytoplasm bind with steroid ligands to form hormone-receptor complexes that eventually translocate to the cell nucleus. There these complexes bind to specific DNA sequences and alter their expression. The complexes may induce the transcription of mRNA leading to synthesis of new proteins. Such proteins include lipocortin, a protein known to inhibit PLA2a and thereby block the synthesis of prostaglandins, leukotrienes, and PAF. Glucocorticoids also inhibit the production of other mediators including AA metabolites such as COX, cytokines, the interleukins, adhesion molecules, and enzymes such as collagenase. /Glucocorticoids/

Kahn, C.M. (Ed.); The Merck Veterinary Manual 9th ed. Merck & Co. Whitehouse Station, NJ. 2005, p. 2128


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Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1738175400,"product":"PREDNISOLONE IP PREDNISOLONE IP","address":"42,MAHANT ROAD,3,VILE PARLE","city":"MUMBAI,MAHARASHTRA","supplier":"SINOBRIGHT PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI PT","customer":"PRATISTHA PHARMA","customerCountry":"INDIA","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"238","totalValueFC":"36060.5","currency":"USD","unitRateINR":"20729.8","date":"30-Jan-2025","totalValueINR":"3109470","totalValueInUsd":"36060.5","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29372100","bill_no":"8087192","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI PT","supplierAddress":"OFFICE F,32\/F,PLAZA 88,NO.88 YEUNG UK ROAD, TSUEN WAN NT, HONG KONG SDNF","customerAddress":"42,MAHANT ROAD,3,VILE PARLE"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740335400,"product":"PREDNISOLONE BP\/USP PREDNISOLONE BP\/USP","address":"3-A, SHIV SAGAR ESTATE, NORTH WING,","city":"BOMBAY ,MAHARASHTRA","supplier":"EVERPROS PHARMA CO LIMITED","supplierCountry":"HONG KONG","foreign_port":"BEIJING","customer":"ANUH PHARMA LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"230","totalValueFC":"23207.9","currency":"USD","unitRateINR":"20182.5","date":"24-Feb-2025","totalValueINR":"2018250","totalValueInUsd":"23207.9","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"8536787","productDescription":"API","marketType":"","country":"HONG KONG","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"ROOM1801 EASEY COMM.BLDG 253-261 HE NNESSY ROAD WANCHAI, HONG KONG SDNF Hong Kong","customerAddress":"3-A, SHIV SAGAR ESTATE, NORTH WING,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741545000,"product":"REIMPORT OF PREDNISOLONE HEMISUCCINATE (SB NO.3593755 DT 29.08.2024 INV NO.111005355 DT. 23.08.2024)REIMPORT OF PREDNISOLONE HEMISUCCINATE (SB NO.3593755 DT 29.","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"FLAVINE EUROPE GMBH","supplierCountry":"INDIA","foreign_port":"MARSEILLE","customer":"SYMBIOTEC PHARMALAB PRIVATE LIMITED","customerCountry":"INDIA","quantity":"35.60","actualQuantity":"35.6","unit":"KGS","unitRateFc":"1321.3","totalValueFC":"47680.6","currency":"USD","unitRateINR":"116010.6","date":"10-Mar-2025","totalValueINR":"4129977.36","totalValueInUsd":"47680.6","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"8805117","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MARSEILLE","supplierAddress":"WEHRLESTR. 12 81679 MUNCHEN, GERMAN Y SDNF Germany","customerAddress":"385\/2, GRAM PIGDEMBER,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742409000,"product":"PREDNISOLONE IP PREDNISOLONE IP","address":"218\/219, 2ND FLOOR,KAILASH PLAZA,","city":"GHATKOPAR EAST,MUMBAI, MAHARASTHRA","supplier":"ZHEJIANG XIANJU PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"AQUATIC REMEDIES LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"259.5","totalValueFC":"6577.2","currency":"USD","unitRateINR":"22788","date":"20-Mar-2025","totalValueINR":"569700","totalValueInUsd":"6577.2","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"9001098","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"NO.1 XIANYAO ROAD, XIANJU, ZHEJIANG ,CHINA SDNF China","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742581800,"product":"PREDNISOLONE IP \/EP PREDNISOLONE IP","address":"A\/ 201, KRISHNA NAGARI, S.V. ROAD,","city":"BORIVALI- WEST, MUMBAI, M.S.","supplier":"HENAN LIHUA PHARMACETUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"ZHENGZHOU","customer":"CENTRAL LIFECARE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"233","totalValueFC":"46967.1","currency":"USD","unitRateINR":"20340.9","date":"22-Mar-2025","totalValueINR":"4068180","totalValueInUsd":"46967.1","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"9043024","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"ZHENGZHOU","supplierAddress":". MIDDLE OF HUANGHE STREET, ANYANG HI- TECH INDUSTRY DEVELOPMENT ZONE, HENAN CHINA","customerAddress":"A\/ 201, KRISHNA NAGARI, S.V. ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1744741800,"product":"PREDNISOLONE (NOT FOR MEDICINAL USE) PREDNISOLONE (NOT FOR MEDICINAL USE)","address":"194, ARVIND CHAMBER, GAURI STUDIO","city":"ANDHERI EAST, MUMBAI.","supplier":"ZHEJIANG XIANJU PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"HANGCHOW (HANGZHOU)","customer":"AVIK PHARMACEUTICAL LIMITED","customerCountry":"INDIA","quantity":"210.00","actualQuantity":"210","unit":"KGS","unitRateFc":"230","totalValueFC":"48863.2","currency":"USD","unitRateINR":"19918","date":"16-Apr-2025","totalValueINR":"4182780","totalValueInUsd":"48863.2","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"9519004","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"HANGCHOW (HANGZHOU)","supplierAddress":"NO.1,XIANYAO ROAD, XIANJU ZHEJIANG CHINA SDNF China","customerAddress":"194, ARVIND CHAMBER, GAURI STUDIO"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745778600,"product":"PREDNISOLONE IP PREDNISOLONE IP","address":"48, CHANDRA GUPTA ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"SINOBRIGHT PHARMACEUTICAL INDUSTRIES LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GORANG INTERNATIONAL","customerCountry":"INDIA","quantity":"200.00","actualQuantity":"200","unit":"KGS","unitRateFc":"230.3","totalValueFC":"46492.9","currency":"USD","unitRateINR":"19899.4","date":"28-Apr-2025","totalValueINR":"3979877.6","totalValueInUsd":"46492.9","indian_port":"JNPT SEZ\/MUMBAI","hs_no":"29372100","bill_no":"9757699","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO.88, YEU NG UK ROAD, TSUEN WAN, HONG KONG, C HINA ., ., China China","customerAddress":"48, CHANDRA GUPTA ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1745951400,"product":"PREDNISOLONE IP\/BP\/USP PREDNISOLONE IP\/BP\/USP","address":"A\/ 201, KRISHNA NAGARI, S.V. ROAD,","city":"BORIVALI- WEST, MUMBAI, M.S.","supplier":"HENAN LIHUA PHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"CENTRAL LIFECARE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"230","totalValueFC":"23214.5","currency":"USD","unitRateINR":"19872","date":"30-Apr-2025","totalValueINR":"1987200","totalValueInUsd":"23214.5","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"9794895","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"MIDDLE OF HUANGHE STREET,ANYANG H I-TEC H INDUSTRY DEVELOPMENT ZONE ,HENAN, CHINA China","customerAddress":"A\/ 201, KRISHNA NAGARI, S.V. ROAD,"}]
11-Jan-2022
30-Apr-2025
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ABOUT THIS PAGE

Looking for 50-24-8 / Prednisolone API manufacturers, exporters & distributors?

Prednisolone manufacturers, exporters & distributors 1

13

PharmaCompass offers a list of Prednisolone 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 Prednisolone manufacturer or Prednisolone supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prednisolone manufacturer or Prednisolone supplier.

PharmaCompass also assists you with knowing the Prednisolone API Price utilized in the formulation of products. Prednisolone API Price is not always fixed or binding as the Prednisolone Price is obtained through a variety of data sources. The Prednisolone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Prednisolone

Synonyms

50-24-8, Metacortandralone, Hydroretrocortine, Predonine, Delta-cortef, Deltacortril

Cas Number

50-24-8

Unique Ingredient Identifier (UNII)

9PHQ9Y1OLM

About Prednisolone

A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.

Bubbli-Pred Manufacturers

A Bubbli-Pred manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bubbli-Pred, including repackagers and relabelers. The FDA regulates Bubbli-Pred manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bubbli-Pred 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 Bubbli-Pred manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Bubbli-Pred Suppliers

A Bubbli-Pred supplier is an individual or a company that provides Bubbli-Pred active pharmaceutical ingredient (API) or Bubbli-Pred finished formulations upon request. The Bubbli-Pred suppliers may include Bubbli-Pred API manufacturers, exporters, distributors and traders.

click here to find a list of Bubbli-Pred suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Bubbli-Pred USDMF

A Bubbli-Pred DMF (Drug Master File) is a document detailing the whole manufacturing process of Bubbli-Pred active pharmaceutical ingredient (API) in detail. Different forms of Bubbli-Pred DMFs exist exist since differing nations have different regulations, such as Bubbli-Pred USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Bubbli-Pred DMF submitted to regulatory agencies in the US is known as a USDMF. Bubbli-Pred USDMF includes data on Bubbli-Pred's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Bubbli-Pred USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Bubbli-Pred suppliers with USDMF on PharmaCompass.

Bubbli-Pred 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 Bubbli-Pred Drug Master File in Japan (Bubbli-Pred JDMF) empowers Bubbli-Pred 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 Bubbli-Pred JDMF during the approval evaluation for pharmaceutical products. At the time of Bubbli-Pred 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 Bubbli-Pred suppliers with JDMF on PharmaCompass.

Bubbli-Pred KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Bubbli-Pred Drug Master File in Korea (Bubbli-Pred KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bubbli-Pred. The MFDS reviews the Bubbli-Pred KDMF as part of the drug registration process and uses the information provided in the Bubbli-Pred KDMF to evaluate the safety and efficacy of the drug.

After submitting a Bubbli-Pred 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 Bubbli-Pred API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Bubbli-Pred suppliers with KDMF on PharmaCompass.

Bubbli-Pred CEP

A Bubbli-Pred CEP of the European Pharmacopoeia monograph is often referred to as a Bubbli-Pred Certificate of Suitability (COS). The purpose of a Bubbli-Pred CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Bubbli-Pred EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Bubbli-Pred to their clients by showing that a Bubbli-Pred CEP has been issued for it. The manufacturer submits a Bubbli-Pred CEP (COS) as part of the market authorization procedure, and it takes on the role of a Bubbli-Pred CEP holder for the record. Additionally, the data presented in the Bubbli-Pred CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Bubbli-Pred DMF.

A Bubbli-Pred CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Bubbli-Pred 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 Bubbli-Pred suppliers with CEP (COS) on PharmaCompass.

Bubbli-Pred WC

A Bubbli-Pred written confirmation (Bubbli-Pred WC) is an official document issued by a regulatory agency to a Bubbli-Pred manufacturer, verifying that the manufacturing facility of a Bubbli-Pred active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Bubbli-Pred APIs or Bubbli-Pred finished pharmaceutical products to another nation, regulatory agencies frequently require a Bubbli-Pred WC (written confirmation) as part of the regulatory process.

click here to find a list of Bubbli-Pred suppliers with Written Confirmation (WC) on PharmaCompass.

Bubbli-Pred 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 Bubbli-Pred as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Bubbli-Pred 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 Bubbli-Pred 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 Bubbli-Pred and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Bubbli-Pred NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Bubbli-Pred suppliers with NDC on PharmaCompass.

Bubbli-Pred GMP

Bubbli-Pred 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 Bubbli-Pred 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 Bubbli-Pred GMP manufacturer or Bubbli-Pred GMP API supplier for your needs.

Bubbli-Pred CoA

A Bubbli-Pred CoA (Certificate of Analysis) is a formal document that attests to Bubbli-Pred's compliance with Bubbli-Pred specifications and serves as a tool for batch-level quality control.

Bubbli-Pred CoA mostly includes findings from lab analyses of a specific batch. For each Bubbli-Pred 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.

Bubbli-Pred may be tested according to a variety of international standards, such as European Pharmacopoeia (Bubbli-Pred EP), Bubbli-Pred JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bubbli-Pred 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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