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ACTIVE PHARMA INGREDIENTS

52 API Suppliers, 29 USDMF, 14 CEP/COS, 6 JDMF, 5 EU WC, 10 KDMF, 39 NDC API, 1 VMF, 25 Listed Suppliers, $ API Reference Price

52 API Suppliers
29 USDMF
14 CEP/COS
6 JDMF
5 EU WC
10 KDMF
39 NDC API
1 VMF
25 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

21 Drugs in Development

21 Drugs in Development

FINISHED DOSAGE FORMULATIONS

384 FDF Dossiers, 230 FDA Orange Book, 83 Europe, 13 Canada, 6 Australia, 27 South Africa, 25 Listed Dossiers

384 FDF Dossiers
230 FDA Orange Book
83 Europe
13 Canada
6 Australia
27 South Africa
25 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%, CREAM;TOPICAL - 5%;1%, OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CREAM;TOPICAL - 1%, TABLET;ORAL - 10MG, TABLET;ORAL - 20MG, TABLET;ORAL - 5MG

drugProductComposition
SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%
CREAM;TOPICAL - 5%;1%
OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
CREAM;TOPICAL - 1%
TABLET;ORAL - 10MG
TABLET;ORAL - 20MG
TABLET;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

5 Rochem International Inc, 8 SPI Pharma, 2 Seqens, 16 DKSH, 1 Pharm-RX Chemical, 7 Faran Shimi Pharmaceutical, 13 Gangwal Healthcare, 24 Nanjing Well Pharmaceutical, 5 Pfanstiehl, 22 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 42 BASF, 3 BioSpectra, 1 Clariant, 15 Corel Pharma Chem, 7 DFE Pharma, 6 Finar, 16 Gangwal Chemicals, 2 Hayashibara, 3 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 31 Kerry, 9 Lubrizol Life Science Health, 17 Microlex e.U, 3 Nanjing Bold Chemical, 2 Nippon Fine Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 8 Pluviaendo, 4 Prachin Chemical, 33 Roquette, 21 Seppic, 2 Shandong Focus Biotechnology Co., Ltd, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 2 Valens Pharmachem, 5 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

relatedExcipients
5 Rochem International Inc
8 SPI Pharma
2 Seqens
16 DKSH
1 Pharm-RX Chemical
7 Faran Shimi Pharmaceutical
13 Gangwal Healthcare
24 Nanjing Well Pharmaceutical
5 Pfanstiehl
22 Actylis
1 Aeon Procare
7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
42 BASF
3 BioSpectra
1 Clariant
15 Corel Pharma Chem
7 DFE Pharma
6 Finar
16 Gangwal Chemicals
2 Hayashibara
3 Ideal Cures Pvt Ltd
4 Ingredion Pharma Solutions
31 Kerry
9 Lubrizol Life Science Health
17 Microlex e.U
3 Nanjing Bold Chemical
2 Nippon Fine Chemical
2 Nomisma Healthcare
1 Novo Excipients
2 Pharmatrans-Sanaq
8 Pluviaendo
4 Prachin Chemical
33 Roquette
21 Seppic
2 Shandong Focus Biotechnology Co., Ltd
5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
1 Shijiazhuang Huaxu Pharmaceutical
11 Sigachi Industries
2 Valens Pharmachem
5 Vasa Pharmachem
1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

88 Topical, 75 Fillers, Diluents & Binders, 57 Solubilizers, 57 Thickeners and Stabilizers, 44 Parenteral, 40 Direct Compression, 30 Coating Systems & Additives, 29 Lubricants & Glidants, 29 Disintegrants & Superdisintegrants, 28 Granulation, 27 Emulsifying Agents, 24 Controlled & Modified Release, 20 Co-Processed Excipients, 20 Film Formers & Plasticizers, 20 Surfactant & Foaming Agents, 18 Taste Masking, 11 Chewable & Orodispersible Aids, 8 Rheology Modifiers, 5 API Stability Enhancers, 2 Coloring Agents, 1 Soft Gelatin

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 47 NEWS #PharmaBuzz

media
4 DATA COMPILATION #PharmaFlow
47 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

8 US Medicaid Prescriptions, 91 Finished Drug Prices, 1 Annual Reports

globalSalesInformation
8 US Medicaid Prescriptions
91 Finished Drug Prices
1 Annual Reports

MARKET PLACE

28 APIs, 16 FDF Dossiers

marketPlace
28 APIs
16 FDF Dossiers

PATENTS & EXCLUSIVITIES

12 US Patents

patents
12 US Patents

REF. STANDARDS & IMPURITIES

4 EDQM , 4 USP , 3 JP , 5 Others

otherSolutions
4 EDQM
4 USP
3 JP
5 Others

ANALYTICAL

2 BioAnalytical Methods, 4 Analytical Methods

otherMethods
2 BioAnalytical Methods
4 Analytical Methods

EuroAPI Hydrocortisone

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 589

MARKET PLACE

API

FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

384

FDF Dossiers

230

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

21DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

News #PharmaBuzz

GLOBAL SALES INFORMATION

US Medicaid (USD)

3,419,784

Annual Reports (USD Million)

Finished Drug Prices

370 RELATED EXCIPIENT COMPANIES

633EXCIPIENTS BY APPLICATIONS

Chemistry

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Click the button for full data set

Also known as: Cortisol, 50-23-7, Acticort, Cetacort, Cortef, Hydrasson

Molecular Formula

C₂₁H₃₀O₅

Molecular Weight

362.5 g/mol

InChI Key

JYGXADMDTFJGBT-VWUMJDOOSA-N

FDA UNII

WI4X0X7BPJ

The main glucocorticoid secreted by the ADRENAL CORTEX. Its synthetic counterpart is used, either as an injection or topically, in the treatment of inflammation, allergy, collagen diseases, asthma, adrenocortical deficiency, shock, and some neoplastic conditions.

Hydrocortisone is a Corticosteroid. The mechanism of action of hydrocortisone is as a Corticosteroid Hormone Receptor Agonist.

1 2D Structure

Hydrocortisone

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-2,6,7,8,9,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-3-one

2.1.2 InChI

InChI=1S/C21H30O5/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/h9,14-16,18,22,24,26H,3-8,10-11H2,1-2H3/t14-,15-,16-,18+,19-,20-,21-/m0/s1

2.1.3 InChI Key

JYGXADMDTFJGBT-VWUMJDOOSA-N

2.1.4 Canonical SMILES

CC12CCC(=O)C=C1CCC3C2C(CC4(C3CCC4(C(=O)CO)O)C)O

2.1.5 Isomeric SMILES

C[C@]12CCC(=O)C=C1CC[C@@H]3[C@@H]2[C@H](C[C@]4([C@H]3CC[C@@]4(C(=O)CO)O)C)O

2.2 Other Identifiers

2.2.1 UNII

WI4X0X7BPJ

2.3 Synonyms

2.3.1 MeSH Synonyms

1. 11 Epicortisol

2. 11-epicortisol

3. Cortef

4. Cortifair

5. Cortisol

6. Cortril

7. Epicortisol

8. Hydrocortisone, (11 Alpha)-isomer

9. Hydrocortisone, (9 Beta,10 Alpha,11 Alpha)-isomer

10. Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-

2.3.2 Depositor-Supplied Synonyms

1. Cortisol

2. 50-23-7

3. Acticort

4. Cetacort

5. Cortef

6. Hydrasson

7. Hydrocortisyl

8. Hydrocortone

9. Cobadex

10. Hytone

11. Cortenema

12. Cortril

13. Dermacort

14. Proctocort

15. Hycort

16. Signef

17. 17-hydroxycorticosterone

18. Optef

19. Kendall's Compound F

20. Cort-dome

21. Cortanal

22. Corticreme

23. Cortifan

24. Cortiment

25. Cortispray

26. Cortonema

27. Dermolate

28. Efcorbin

29. Efcortelan

30. Eldecort

31. Ficortril

32. Genacort

33. Hycortol

34. Hycortole

35. Penecort

36. Permicort

37. Tarcortin

38. Traumaide

39. Alacort

40. Cleiton

41. Epicort

42. Dihydrocostisone

43. Hytone Lotion

44. Hidro-colisona

45. Hydro-adreson

46. Scheroson F

47. Incortin-h

48. Reichstein's Substance M

49. Ala-scalp

50. Domolene-hc

51. Epiderm H

52. Esiderm H

53. Otosone-f

54. Polcort H

55. Aeroseb-hc

56. Cortolotion

57. Cortoxide

58. Cremesone

59. Eldercort

60. Heb-cort

61. Maintasone

62. Nutracort

63. Delacort

64. Dioderm

65. Mildison

66. Rectoid

67. Synacort

68. Anflam

69. Hydrocorticosterone

70. Hydroxycortisone

71. H-cort

72. Hydro-colisona

73. Cortisol Alcohol

74. Incortin-hydrogen

75. Ala-cort

76. Barseb Hc

77. Dermocortal

78. Flexicort

79. Texacort

80. Timocort

81. Evacort

82. Komed Hc

83. Hydrocortisone Base

84. Lacticare-hc

85. Texacort Lotion 25

86. Anti-inflammatory Hormone

87. Hydrocortisone Alcohol

88. Algicirtis

89. Aquacort

90. Colocort

91. Cortesal

92. Cortisolonum

93. Hidalone

94. Hytisone

95. Kyypakkaus

96. Lactisona

97. Lubricort

98. Meusicort

99. Milliderm

100. Sanatison

101. Schericur

102. Sigmacort

103. Stiefcorcil

104. Amberin

105. Cutisol

106. Dermil

107. Glycort

108. Uniderm

109. Foille Insetti

110. Gyno-cortisone

111. Balneol-hc

112. Transderma H

113. Basan-corti

114. Clear Aid

115. Cremicort-h

116. Dome-cort

117. Stie-cort

118. Beta-hc

119. Neosporin-h Ear

120. Remederm Hc

121. Aquanil Hc

122. Cortisporin Otico

123. Derm-aid

124. Heb Cort

125. Nogenic Hc

126. Scalpicin Capilar

127. Systral Hydrocort

128. Prevex Hc

129. Cortisporin

130. Efcortelin

131. Fiocortril

132. Hidrocortisona

133. Hydrocortisone Free Alcohol

134. Hydrocortisonum

135. Proctofoam

136. Alphaderm

137. Hydracort

138. Medicort

139. Otocort

140. Zenoxone

141. Drotic

142. Vytone

143. 11beta-hydroxycortisone

144. Nystaform-hc

145. Aeroseb Hc

146. Caldecort Spray

147. Anusol Hc

148. Pediotic Suspension

149. Vosol Hc

150. Idrocortisone

151. 17alpha-hydroxycorticosterone

152. Hydrocortal

153. Hydroskin

154. Otalgine

155. Otobiotic

156. Plenadren

157. Protocort

158. Hysone

159. Racet

160. Ef Corlin

161. 11beta-hydrocortisone

162. Compound F

163. Lacticare Hc

164. Compound F (kendall)

165. 11-beta-hydrocortisone

166. 11-beta-hydroxycortisone

167. Hydrocortisone (cortisol)

168. Chronocort

169. Hydrocort

170. Preparation H Hydrocortisone Cream

171. Neo-cort-dome

172. 11beta,17alpha,21-trihydroxy-4-pregnene-3,20-dione

173. Otic-neo-cort-dome

174. 11beta,17,21-trihydroxypregn-4-ene-3,20-dione

175. Nsc 10483

176. Hc

177. [3h]cortisol

178. Nsc-10483

179. (11beta)-11,17,21-trihydroxypregn-4-ene-3,20-dione

180. Prestwick_265

181. (8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-3-one

182. 4-pregnene-11beta,17alpha,21-triol-3,20-dione

183. Chebi:17650

184. 11beta,17alpha,21-trihydroxypregn-4-ene-3,20-dione

185. Nsc10483

186. 11.beta.-hydrocortisone

187. Dermaspray

188. Wi4x0x7bpj

189. 11beta,17,21-trihydroxyprogesterone

190. 11.beta.-hydroxycortisone

191. Ophthocort

192. Terra-cortril

193. Mls000069609

194. 17.alpha.-hydroxycorticosterone

195. Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11.beta.)-

196. Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11beta)-

197. 4-pregnen-11beta,17alpha,21-triol-3,20-dione

198. Idrocortisone [dcit]

199. Genacort (lotion)

200. Anucort

201. Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11b)-

202. Prepcort

203. Smr000059022

204. Dsstox_cid_714

205. Hydrocortisonum [inn-latin]

206. Proctozone Hc

207. Scalp-cort

208. Hidrocortisona [inn-spanish]

209. Rectasol-hc

210. Anucort-hc

211. Hydro-rx

212. Dsstox_rid_75753

213. Dsstox_gsid_20714

214. (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-1h-cyclopenta[a]phenanthren-3(2h)-one

215. Hc (hydrocortisone)

216. 11.beta.,17,21-trihydroxypregn-4-ene-3,20-dione

217. Corhydron

218. (11alpha,14beta)-11,17,21-trihydroxypregn-4-ene-3,20-dione

219. Duocort

220. Hydrocortisone In Absorbase

221. Proctosol-hc

222. Hc #1

223. Hc #4

224. Acticort (tn)

225. Colocort (tn)

226. (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}]heptadec-6-en-5-one

227. Smr000653523

228. Cortef (tn)

229. Hytone (tn)

230. Ccris 5854

231. Component Of Otalgine

232. Anusol Hc (tn)

233. Component Of Lubricort

234. Cor-oticin

235. Hsdb 3339

236. Einecs 200-020-1

237. Unii-wi4x0x7bpj

238. Mfcd00011654

239. Component Of Neo-cort-dome

240. Cortizol

241. Efmody

242. Ai3-25006

243. 3h-cortisol

244. 11beta-cortisol

245. Cas-50-23-7

246. 11-hydrocortisone

247. Plenadren (tn)

248. Ncgc00022848-06

249. 11b-hydrocortisone

250. Hydrocortisone [usp:inn:ban:jan]

251. Drotic (salt/mix)

252. 11b-hydroxycortisone

253. Otocort (salt/mix)

254. Pregn-4-ene-3,20-dione, 11beta,17,21-trihydroxy-

255. Otalgine (salt/mix)

256. Hydrocortisone, 98%

257. 11,17,21-trihydroxypregn-4-ene-3,20-dione

258. Alkindi Sprinkle

259. Alphaderm (salt/mix)

260. Hydrocortisone, Topical

261. Otobiotic (salt/mix)

262. 4p6x

263. Cort-quin (salt/mix)

264. Cortisporin (salt/mix)

265. Vosol Hc (salt/mix)

266. 11a-hydroxycorticosterone

267. 17a-hydroxycorticosterone

268. Opera_id_1292

269. Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-, (11-beta)-

270. Prestwick0_000447

271. Prestwick1_000447

272. Prestwick2_000447

273. Prestwick3_000447

274. Epitope Id:174851

275. Upcmld-dp133

276. Ec 200-020-1

277. H 4001

278. Hydrocortisone [ii]

279. Hydrocortisone [mi]

280. Schembl4148

281. Neo-cort-dome (salt/mix)

282. Hydrocortisone [inn]

283. Hydrocortisone [jan]

284. Lopac0_000594

285. 11alpha-hydroxycorticosterone

286. Bspbio_000494

287. Hydrocortisone [hsdb]

288. Mls001148103

289. Mls002207135

290. Mls002222189

291. Mls002548868

292. Hydrocortisone [vandf]

293. Spbio_002433

294. Hydrocortisone [mart.]

295. Bpbio1_000544

296. Chembl389621

297. Gtpl2868

298. Hydrocortisone [usp-rs]

299. Hydrocortisone [who-dd]

300. Hydrocortisone [who-ip]

301. Pediotic Suspension (salt/mix)

302. Dtxsid7020714

303. Upcmld-dp133:001

304. Bdbm13775

305. Otic-neo-cort-dome (salt/mix)

306. 2v95

307. Hydrocortisone (jp17/usp/inn)

308. Hms1569i16

309. Hms2090m04

310. Hms2096i16

311. Hms2230b18

312. Hms2235f17

313. Hms3259c05

314. Hms3261h10

315. Hms3713i16

316. Hydrocortisone, >=98% (hplc)

317. Vioform-hydrocortisone (salt/mix)

318. 11b,17,21-trihydroxyprogesterone

319. Hydrocortisone [green Book]

320. Bcp09054

321. Hy-n0583

322. Hydrocortisone [orange Book]

323. Tox21_110883

324. Tox21_200815

325. Tox21_500594

326. Hydrocortisone [ep Monograph]

327. Lmst02030001

328. S1696

329. Zinc13540519

330. Hydrocortisone [usp Monograph]

331. Akos001582651

332. Hydrocortisonum [who-ip Latin]

333. Oticair Component Hydrocortisone

334. Otocort Component Hydrocortisone

335. Tox21_110883_1

336. Ccg-204683

337. Db00741

338. Lp00594

339. Nc00456

340. Sdccgsbi-0050576.p003

341. 11.beta.,17,21-trihydroxyprogesterone

342. Cipro Hc Component Hydrocortisone

343. Orlex Hc Component Hydrocortisone

344. Otobione Component Hydrocortisone

345. Pediotic Component Hydrocortisone

346. Pyocidin Component Hydrocortisone

347. Smp1_000156

348. Vosol Hc Component Hydrocortisone

349. Alphaderm Component Hydrocortisone

350. Ncgc00022848-07

351. Ncgc00022848-09

352. Ncgc00022848-10

353. Ncgc00022848-11

354. Ncgc00022848-12

355. Ncgc00022848-13

356. Ncgc00022848-14

357. Ncgc00022848-15

358. Ncgc00022848-17

359. Ncgc00022848-26

360. Ncgc00258369-01

361. Ncgc00261279-01

362. Otobiotic Component Hydrocortisone

363. (1s,10s,11s,15s,17s,2r,14r)-14,17-dihydroxy-14-(2-hydroxyacetyl)-2,15-dimethyl Tetracyclo[8.7.0.0<2,7>.0<11,15>]heptadec-6-en-5-one

364. (8s,9s,10r,11s,13s,14s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3h-cyclopenta[a]phenanthren-3-one

365. Ac-12902

366. As-11651

367. Bp-20390

368. Hydrocortisone 100 Microg/ml In Methanol

369. Hydrocortisone Component Of Oticair

370. Hydrocortisone Component Of Otocort

371. Nci60_000118

372. Acetasol Hc Component Hydrocortisone

373. Calmurid Hc Component Hydrocortisone

374. Hydrocortisone Component Of Otobione

375. Hydrocortisone Component Of Pediotic

376. Hydrocortisone Component Of Pyocidin

377. 4-pregnene-11alpha,21-triol 3,20-dione

378. Hydrocortisone Component Of Alphaderm

379. Hydrocortisone Component Of Cipro Hc

380. Hydrocortisone Component Of Orlex Hc

381. Hydrocortisone Component Of Otobiotic

382. Hydrocortisone Component Of Vosol Hc

383. B1951

384. Eu-0100594

385. Prednisolone Impurity A [ep Impurity]

386. 4-pregnene-11b,17a,21-triol-3,20-dione

387. Hydrocortisone 100 Microg/ml In Acetonitrile

388. Hydrocortisone Component Of Acetasol Hc

389. Hydrocortisone Component Of Calmurid Hc

390. 50h237

391. C00735

392. D00088

393. U 1851

394. Hydrocortisone, Meets Usp Testing Specifications

395. Pregn-4-ene-3, 11.beta.,17,21-trihydroxy-

396. 11?,17?,21-trihydroxypregn-4-ene-3,20-dione

397. A929789

398. Hydrocortisone, Vetranal(tm), Analytical Standard

399. Q190875

400. Sr-01000000139

401. Q-201211

402. Sr-01000000139-3

403. Brd-k93568044-001-03-1

404. Brd-k93568044-001-11-4

405. Brd-k93568044-001-32-0

406. Hydrocortisone Acetate Impurity A [ep Impurity]

407. Hydrocortisone, Bioreagent, Suitable For Cell Culture

408. 4-pregnen-11.beta.,17.alpha.,21-triol-3,20-dione

409. 4-pregnene-11.beta.,17.alpha.,21-triol-3,20-dione

410. Pregn-4-ene-3,20-dione, 11.beta.,17,21-trihydroxy-

411. Z2786051549

412. (11beta)-11,17,21-trihydroxy-pregn-4-ene-3,20-dione

413. 11.beta.,17.alpha.,21-trihydroxy-4-pregnene-3,20-dione

414. 11.beta.,17.alpha.,21-trihydroxypregn-4-ene-3,20-dione

415. B48448a1-24ba-47ca-8d9e-43e5bc949386

416. Hydrocortisone, British Pharmacopoeia (bp) Assay Standard

417. Pregn-4-ene-3, 11,17,21-trihydroxy-, (11.beta.)-

418. 11,17,21-trihydroxypregn-4-ene-3,20-dione, (11.beta.)-

419. Hydrocortisone Sodium Succinate Impurity A [ep Impurity]

420. Hydrocortisone, European Pharmacopoeia (ep) Reference Standard

421. Hydrocortisone Hydrogen Succinate Impurity A [ep Impurity]

422. Hydrocortisone, United States Pharmacopeia (usp) Reference Standard

423. Hydrocortisone-water Soluble, Bioreagent, Suitable For Cell Culture

424. Hydrocortisone, Gamma-irradiated, Powder, Bioxtra, Suitable For Cell Culture

425. 4-(6-chloro-4-oxoquinazolin-3(4h)-yl)-n-(3-methoxyphenyl)piperidine-1-carboxamide

426. Cortisol Solution, 1.0 Mg/ml In Methanol, Ampule Of 1 Ml, Certified Reference Material

427. Hydrocortisone For Peak Identification, European Pharmacopoeia (ep) Reference Standard

428. Hydrocortisone Solution, 50 Mum, Sterile-filtered, Bioxtra, Suitable For Cell Culture

429. Hydrocortisone, Pharmaceutical Secondary Standard; Certified Reference Material

430. (10r,13s,17r)-11,17-dihydroxy-17-(2-hydroxyacetyl)-10,13-dimethyl-2,6,7,8,9,11,12,14,15,16-decahydro-1h-cyclopenta[a]phenanthren-3-one

2.3.3 Other Synonyms

1. Efficort

2. Retef

3. Hydrocortisone Aceponate

4. Cortef Fluid

5. Hydrocortisone Cypionate

6. Hidroaltesona

7. Hydrocortone Phosphate

8. Hydrocortisone Phosphate

9. Hydrocortisone Sodium Phosphate

10. Aacicortisol

11. Hydrocortisone Hydrogen Succinate

12. Hydrocortisone Hemisuccinate Hydrate

13. Hydrocortisone Hemisuccinate

14. Hydrocortisone 21-hemisuccinate

2.4 Create Date

2004-09-16

3 Chemical and Physical Properties

Molecular Formula	C₂₁H₃₀O₅
Molecular Weight	362.5 g/mol
XLogP3	1.6
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	5
Rotatable Bond Count	2
Exact Mass	362.20932405 g/mol
Monoisotopic Mass	362.20932405 g/mol
Topological Polar Surface Area	94.8 Å²
Heavy Atom Count	26
Formal Charge	0
Complexity	684
Isotope Atom Count	0
Defined Atom Stereocenter Count	7
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

4 Drug and Medication Information

4.1 Drug Information

1 of 36
Drug Name	Acetasol hc
PubMed Health	Acetic Acid/Hydrocortisone (Into the ear)
Drug Classes	Anti-Infective/Anti-Inflammatory Combination
Active Ingredient	Acetic acid, glacial; hydrocortisone
Dosage Form	Solution/drops
Route	Otic
Strength	1%; 2%
Market Status	Prescription
Company	Actavis Mid Atlantic

2 of 36
Drug Name	Ala-cort
PubMed Health	Hydrocortisone
Drug Classes	Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
Active Ingredient	Hydrocortisone
Dosage Form	Cream
Route	Topical
Strength	1%
Market Status	Prescription
Company	Crown Labs

3 of 36
Drug Name	Ala-scalp
PubMed Health	Hydrocortisone (On the skin)
Drug Classes	Corticosteroid, Intermediate, Corticosteroid, Weak
Active Ingredient	Hydrocortisone
Dosage Form	Lotion
Route	Topical
Strength	2%
Market Status	Prescription
Company	Crown Labs

4 of 36
Drug Name	Anusol hc
PubMed Health	Hydrocortisone (By mouth)
Drug Classes	Anti-Inflammatory, Endocrine-Metabolic Agent, Immune Suppressant
Active Ingredient	Hydrocortisone
Dosage Form	Cream
Route	Topical
Strength	2.5%
Market Status	Prescription
Company	Salix Pharms

5 of 36
Drug Name	Colocort
PubMed Health	Hydrocortisone Enema (Rectal)
Drug Classes	Anti-Inflammatory, Gastrointestinal Agent
Drug Label	Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-,(11)- and the following structural formula:Colocort is a convenien...
Active Ingredient	Hydrocortisone
Dosage Form	Enema
Route	Rectal
Strength	100mg/60ml
Market Status	Prescription
Company	Paddock

6 of 36
Drug Name	Cortef
PubMed Health	Hydrocortisone (Rectal)
Drug Classes	Anti-Inflammatory, Hemorrhoidal Anti-Inflammatory
Drug Label	CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practical...
Active Ingredient	Hydrocortisone
Dosage Form	Tablet
Route	Oral
Strength	5mg; 10mg; 20mg
Market Status	Prescription
Company	Pharmacia And Upjohn

7 of 36
Drug Name	Cortenema
PubMed Health	Neomycin, Polymyxin B, and Hydrocortisone
Drug Classes	Adrenal Glucocorticoid, Aminoglycoside/Corticosteroid Combination, Anti-Infective/Anti-Inflammatory Combination, Neomycin
Drug Label	Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy,(11)-and the following structural formula: CORTENEMA is a convenient...
Active Ingredient	Hydrocortisone
Dosage Form	Enema
Route	Rectal
Strength	100mg/60ml
Market Status	Prescription
Company	Ani Pharms

8 of 36
Drug Name	Cortifoam
PubMed Health	Hydrocortisone
Drug Classes	Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
Active Ingredient	Hydrocortisone acetate
Dosage Form	Aerosol, metered
Route	Rectal
Strength	10%
Market Status	Prescription
Company	Meda Pharms

9 of 36
Drug Name	Cortisporin
PubMed Health	Hydrocortisone
Drug Classes	Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
Active Ingredient	Hydrocortisone acetate; polymyxin b sulfate; Hydrocortisone; Bacitracin zinc; hydrocortisone; neomycin sulfate
Dosage Form	Solution/drops; Suspension/drops; Ointment; Cream
Route	Topical; Otic
Strength	400 units/gm; 10,000 units/gm; 0.5%; 10,000 units/ml; 1%; eq 3.5mg base/ml; eq 3.5mg base/gm; 5,000 units/gm
Market Status	Prescription
Company	Monarch Pharms; Citron Pharma

10 of 36
Drug Name	Hydrocortisone
Active Ingredient	Hydrocortisone
Dosage Form	Ointment; Enema; Tablet; Cream; Lotion
Route	Rectal; Oral; Topical
Strength	1%; 5mg; 10mg; 2.5%; 100mg/60ml; 20mg
Market Status	Prescription
Company	Vintage Pharms; Amedra Pharms; Taro; Fougera; Lyne; Fougera Pharms; Teva Pharms; Actavis Mid Atlantic; Vintage; Perrigo New York

11 of 36
Drug Name	Hydrocortisone and acetic acid
Drug Label	Topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Texacort Topical Solution contains hydrocortisone as the active corticosteroid, having the chemical formula of Pregn-4-ene-3...
Active Ingredient	Acetic acid, glacial; hydrocortisone
Dosage Form	Solution/drops
Route	Otic
Strength	1%; 2%
Market Status	Prescription
Company	Taro; Vintage

12 of 36
Drug Name	Hydrocortisone in absorbase
Active Ingredient	Hydrocortisone
Dosage Form	Ointment
Route	Topical
Strength	1%
Market Status	Prescription
Company	Carolina Medcl

13 of 36
Drug Name	Hydro-rx
PubMed Health	Acetic Acid/Hydrocortisone (Into the ear)
Drug Classes	Anti-Infective/Anti-Inflammatory Combination
Drug Label	Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in wat...
Active Ingredient	Hydrocortisone
Dosage Form	Powder
Route	For rx compounding
Strength	100%
Market Status	Prescription
Company	X Gen Pharms

14 of 36
Drug Name	Nutracort
Active Ingredient	Hydrocortisone
Dosage Form	Lotion
Route	Topical
Strength	2.5%
Market Status	Prescription
Company	Dow Pharm

15 of 36
Drug Name	Stie-cort
Active Ingredient	Hydrocortisone
Dosage Form	Lotion
Route	Topical
Strength	2.5%
Market Status	Prescription
Company	Perrigo

16 of 36
Drug Name	Synacort
Active Ingredient	Hydrocortisone
Dosage Form	Cream
Route	Topical
Strength	1%; 2.5%
Market Status	Prescription
Company	Medicis

17 of 36
Drug Name	Texacort
Active Ingredient	Hydrocortisone
Dosage Form	Solution
Route	Topical
Strength	2.5%
Market Status	Prescription
Company	Mission Pharma

18 of 36
Drug Name	Vosol hc
Active Ingredient	Acetic acid, glacial; hydrocortisone
Dosage Form	Solution/drops
Route	Otic
Strength	1%; 2%
Market Status	Prescription
Company	Hi Tech Pharma

19 of 36
Drug Name	Acetasol hc
PubMed Health	Acetic Acid/Hydrocortisone (Into the ear)
Drug Classes	Anti-Infective/Anti-Inflammatory Combination
Active Ingredient	Acetic acid, glacial; hydrocortisone
Dosage Form	Solution/drops
Route	Otic
Strength	1%; 2%
Market Status	Prescription
Company	Actavis Mid Atlantic

20 of 36
Drug Name	Ala-cort
PubMed Health	Hydrocortisone
Drug Classes	Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
Active Ingredient	Hydrocortisone
Dosage Form	Cream
Route	Topical
Strength	1%
Market Status	Prescription
Company	Crown Labs

21 of 36
Drug Name	Ala-scalp
PubMed Health	Hydrocortisone (On the skin)
Drug Classes	Corticosteroid, Intermediate, Corticosteroid, Weak
Active Ingredient	Hydrocortisone
Dosage Form	Lotion
Route	Topical
Strength	2%
Market Status	Prescription
Company	Crown Labs

22 of 36
Drug Name	Anusol hc
PubMed Health	Hydrocortisone (By mouth)
Drug Classes	Anti-Inflammatory, Endocrine-Metabolic Agent, Immune Suppressant
Active Ingredient	Hydrocortisone
Dosage Form	Cream
Route	Topical
Strength	2.5%
Market Status	Prescription
Company	Salix Pharms

23 of 36
Drug Name	Colocort
PubMed Health	Hydrocortisone Enema (Rectal)
Drug Classes	Anti-Inflammatory, Gastrointestinal Agent
Drug Label	Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione, 11,17,21-trihydroxy-,(11)- and the following structural formula:Colocort is a convenien...
Active Ingredient	Hydrocortisone
Dosage Form	Enema
Route	Rectal
Strength	100mg/60ml
Market Status	Prescription
Company	Paddock

24 of 36
Drug Name	Cortef
PubMed Health	Hydrocortisone (Rectal)
Drug Classes	Anti-Inflammatory, Hemorrhoidal Anti-Inflammatory
Drug Label	CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practical...
Active Ingredient	Hydrocortisone
Dosage Form	Tablet
Route	Oral
Strength	5mg; 10mg; 20mg
Market Status	Prescription
Company	Pharmacia And Upjohn

25 of 36
Drug Name	Cortenema
PubMed Health	Neomycin, Polymyxin B, and Hydrocortisone
Drug Classes	Adrenal Glucocorticoid, Aminoglycoside/Corticosteroid Combination, Anti-Infective/Anti-Inflammatory Combination, Neomycin
Drug Label	Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in water. It has the chemical name Pregn-4-ene-3,20-dione,11,17,21-trihydroxy,(11)-and the following structural formula: CORTENEMA is a convenient...
Active Ingredient	Hydrocortisone
Dosage Form	Enema
Route	Rectal
Strength	100mg/60ml
Market Status	Prescription
Company	Ani Pharms

26 of 36
Drug Name	Cortifoam
PubMed Health	Hydrocortisone
Drug Classes	Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
Active Ingredient	Hydrocortisone acetate
Dosage Form	Aerosol, metered
Route	Rectal
Strength	10%
Market Status	Prescription
Company	Meda Pharms

27 of 36
Drug Name	Cortisporin
PubMed Health	Hydrocortisone
Drug Classes	Anti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
Active Ingredient	Hydrocortisone acetate; polymyxin b sulfate; Hydrocortisone; Bacitracin zinc; hydrocortisone; neomycin sulfate
Dosage Form	Solution/drops; Suspension/drops; Ointment; Cream
Route	Topical; Otic
Strength	400 units/gm; 10,000 units/gm; 0.5%; 10,000 units/ml; 1%; eq 3.5mg base/ml; eq 3.5mg base/gm; 5,000 units/gm
Market Status	Prescription
Company	Monarch Pharms; Citron Pharma

28 of 36
Drug Name	Hydrocortisone
Active Ingredient	Hydrocortisone
Dosage Form	Ointment; Enema; Tablet; Cream; Lotion
Route	Rectal; Oral; Topical
Strength	1%; 5mg; 10mg; 2.5%; 100mg/60ml; 20mg
Market Status	Prescription
Company	Vintage Pharms; Amedra Pharms; Taro; Fougera; Lyne; Fougera Pharms; Teva Pharms; Actavis Mid Atlantic; Vintage; Perrigo New York

29 of 36
Drug Name	Hydrocortisone and acetic acid
Drug Label	Topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Texacort Topical Solution contains hydrocortisone as the active corticosteroid, having the chemical formula of Pregn-4-ene-3...
Active Ingredient	Acetic acid, glacial; hydrocortisone
Dosage Form	Solution/drops
Route	Otic
Strength	1%; 2%
Market Status	Prescription
Company	Taro; Vintage

30 of 36
Drug Name	Hydrocortisone in absorbase
Active Ingredient	Hydrocortisone
Dosage Form	Ointment
Route	Topical
Strength	1%
Market Status	Prescription
Company	Carolina Medcl

31 of 36
Drug Name	Hydro-rx
PubMed Health	Acetic Acid/Hydrocortisone (Into the ear)
Drug Classes	Anti-Infective/Anti-Inflammatory Combination
Drug Label	Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.Hydrocortisone is a white to practically white, odorless, crystalline powder, very slightly soluble in wat...
Active Ingredient	Hydrocortisone
Dosage Form	Powder
Route	For rx compounding
Strength	100%
Market Status	Prescription
Company	X Gen Pharms

32 of 36
Drug Name	Nutracort
Active Ingredient	Hydrocortisone
Dosage Form	Lotion
Route	Topical
Strength	2.5%
Market Status	Prescription
Company	Dow Pharm

33 of 36
Drug Name	Stie-cort
Active Ingredient	Hydrocortisone
Dosage Form	Lotion
Route	Topical
Strength	2.5%
Market Status	Prescription
Company	Perrigo

34 of 36
Drug Name	Synacort
Active Ingredient	Hydrocortisone
Dosage Form	Cream
Route	Topical
Strength	1%; 2.5%
Market Status	Prescription
Company	Medicis

35 of 36
Drug Name	Texacort
Active Ingredient	Hydrocortisone
Dosage Form	Solution
Route	Topical
Strength	2.5%
Market Status	Prescription
Company	Mission Pharma

36 of 36
Drug Name	Vosol hc
Active Ingredient	Acetic acid, glacial; hydrocortisone
Dosage Form	Solution/drops
Route	Otic
Strength	1%; 2%
Market Status	Prescription
Company	Hi Tech Pharma

4.2 Therapeutic Uses

Anti-Inflammatory Agents, Steroidal

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

MEDICATION (VET): Acute urticaria /can be treated by/ rapid-acting adrenocorticosteroids, eg, hydrocortisone ... .

Kahn, C.M. (Ed.); The Merck Veterinary Manual 9th ed. Merck & Co. Whitehouse Station, NJ. 2005, p. 690

MEDICATION (VET): /USED/ IV, IN PREVENTING OR TREATING ADRENAL FAILURE & SHOCK-LIKE CONDITIONS IN SURGICAL CASES WHICH HAVE BEEN ON CORTICOSTEROIDS, IN ACUTE ALLERGIC REACTIONS...IN POOR SURGICAL RISKS, & IN CASES WHICH HAVE HAD OVERWHELMING SYSTEMIC INFECTIONS...IN DOGS OR CATTLE...

Rossoff, I.S. Handbook of Veterinary Drugs. New York: Springer Publishing Company, 1974., p. 266

MEDICATION (VET) /EXPL:/: 5 Standardbreds and 4 Dutch Warmblood horses /were/ used to examine sensitivity of peripheral tissues to exogenous insulin 24 hours after administration of a single dose of hydrocortisone (0.06 mg/kg), eGH (20 ug/kg), or saline (0.9% NaCl) solution and after long-term administration (11 to 15 days) of eGH to horses. The amounts of metabolized glucose (M) and plasma insulin concentration (I) were determined. Values for M and the M-to-I ratio were significantly higher 24 hours after administration of a single dose of hydrocortisone than after single-dose administration of eGH or saline solution. After long-term administration of eGH, basal I concentration was increased and the mean M-to-I ratio was 22% lower, compared with values for horses treated with saline solution. Increases in M and the M-to-I ratio after a single dose of hydrocortisone imply that short-term hydrocortisone treatment increases glucose use by, and insulin sensitivity of, peripheral tissues. Assuming a single dose of hydrocortisone improves sensitivity of peripheral tissues to insulin, it may be an interesting candidate for use in reducing insulin resistance in peripheral tissues of horses with several disease states.

PMID:6334949 de Graaf-Roelfsema E et al; Am J Vet Res 66 (11): 1907-13 (2005)

For more Therapeutic Uses (Complete) data for HYDROCORTISONE (23 total), please visit the HSDB record page.

4.3 Drug Warning

It is not known whether rectal corticosteroids are distributed into breast milk. Systemic corticosteroids are distributed into breast milk and may cause unwanted effects, such as growth suppression, in the infant. Rectal corticosteroids are not recommended for use by breast-feeding mothers. /Corticosteroids, rectal/

Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2007., p. 913

The results of a prospective randomized controlled trial, which looked at the incidence of postoperative diabetes insipidus following the use of three different hydrocortisone protocols, and the results of a study, on the incidence of diabetes insipidus and cortisol response in patients not given hydrocortisone /was reported/. In study 1, 114 patients with pituitary macroadenoma were randomized into three groups: conventional dose (injected hydrocortisone 100 mg IV 6-hourly for 3 days); intermediate dose (injected hydrocortisone 100 mg IV 6-hourly on day 1, 100 mg IV 8-hourly on day 2, and 100 mg IV 12-hourly on day 3); low dose protocol (injected hydrocortisone 25 mg IV 6-hourly on day 1, 25 mg IV 8-hourly on day 2 and 25 mg IV 12-hourly on day 3). Radical excision was achieved in 92 patients. The incidence of diabetes insipidus with the conventional dose was 52%, intermediate dose, 36% and low dose, 24% (p = 0.025). Study 2 included 16 consecutive patients with Hardy's grade A & B pituitary adenoma. These patients were randomized to receive (Group I) or not receive (Group II) hydrocortisone. Patients in Group II demonstrated normal cortisol response intraoperatively and no patient developed features of hypocortisolism; the incidence of diabetes insipidus in this group was 14%. The low dose hydrocortisone protocol reduced the incidence of diabetes insipidus by 46% when compared with the conventional dose hydrocortisone protocol. In patients with grade A and B tumor with normal preoperative cortisol levels, the use of perioperative hydrocortisone can be avoided.

PMID:14635749 Rajaratnam S et al; Br J Neurosurg 17 (5): 437-42 (2003)

ACUTE ADRENAL INSUFFICIENCY RESULTS FROM TOO RAPID WITHDRAWAL OF CORTICOSTEROID THERAPY. /CORTICOSTEROIDS/

Goodman, L.S., and A. Gilman. (eds.) The Pharmacological Basis of Therapeutics. 5th ed. New York: Macmillan Publishing Co., Inc., 1975., p. 1496

POTENTIAL ADVERSE EFFECTS ON FETUS: Cleft palate, spontaneous abortions, and intrauterine growth retardation in animals. Potential for cleft palate formation and adrenal suppression in humans, although teratogenic effects have not been confirmed. POTENTIAL SIDE EFFECTS ON BREAST-FED INFANT: Passes into breast milk in small amounts. Administration of physiologic doses unlikely to adversely affect infant. FDA Category: C (C = Studies in laboratory animals have revealed adverse effects on the fetus (teratogenic, embryocidal, etc.) but there are no controlled studies in pregnant women. The benefits from use of the drug in pregnant women may be acceptable despite its potential risks, or there are no laboratory animal studies or adequate studies in pregnant women.) /Adrenocorticosteroids/ /from table II/

PMID:2195076 Stockton DL, Palle AS; J Am Acad Dermatol 23 (1): 87-103 (1990)

For more Drug Warnings (Complete) data for HYDROCORTISONE (31 total), please visit the HSDB record page.

4.4 Drug Indication

Otic solutions are indicated for infections of the external auditory canal caused by susceptible organisms and with inflammation. Hydrocortisone tablets are indicated for certain endocrine, rheumatic, collagen, allergic, ophthalmic, respiratory, hematologic, neoplastic, edematous, gastrointestinal, and other conditions. A hydrocortisone enema is indicated for ulcerative colitis, a topical ointment with antibiotics is indicated for corticosteroid responsive dermatoses with infections, and a topical cream with [acyclovir] is indicated to treat cold sores. Oral granules of hydrocortisone are used as a replacement therapy for Adrenocortical Insufficiency (AI) in children under 17 years of age.

FDA Label

Replacement therapy of adrenal insufficiency in infants, children and adolescents (from birth to < 18 years old).

Treatment of adrenal insufficiency in adults.

Treatment of adrenocortical insufficiency

Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults.

5 Pharmacology and Biochemistry

5.1 Pharmacology

Hydrocortisone binds to the glucocorticoid receptor leading to downstream effects such as inhibition of phospholipase A2, NF-kappa B, other inflammatory transcription factors, and the promotion of anti-inflammatory genes. Hydrocortisone has a wide therapeutic index and a moderate duration of action. Patients should stop taking the medication if irritation or sensitization occurs.

5.2 MeSH Pharmacological Classification

Anti-Inflammatory Agents

Substances that reduce or suppress INFLAMMATION. (See all compounds classified as Anti-Inflammatory Agents.)

5.3 FDA Pharmacological Classification

5.3.1 Active Moiety

HYDROCORTISONE

5.3.2 FDA UNII

WI4X0X7BPJ

5.3.3 Pharmacological Classes

Corticosteroid [EPC]; Corticosteroid Hormone Receptor Agonists [MoA]

5.4 ATC Code

H02AB09

D07AA02

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

A01 - Stomatological preparations

A01A - Stomatological preparations

A01AC - Corticosteroids for local oral treatment

A01AC03 - Hydrocortisone

A - Alimentary tract and metabolism

A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents

A07E - Intestinal antiinflammatory agents

A07EA - Corticosteroids acting locally

A07EA02 - Hydrocortisone

C - Cardiovascular system

C05 - Vasoprotectives

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

C05AA - Corticosteroids

C05AA01 - Hydrocortisone

D - Dermatologicals

D07 - Corticosteroids, dermatological preparations

D07A - Corticosteroids, plain

D07AA - Corticosteroids, weak (group i)

D07AA02 - Hydrocortisone

D - Dermatologicals

D07 - Corticosteroids, dermatological preparations

D07X - Corticosteroids, other combinations

D07XA - Corticosteroids, weak, other combinations

D07XA01 - Hydrocortisone

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

H02 - Corticosteroids for systemic use

H02A - Corticosteroids for systemic use, plain

H02AB - Glucocorticoids

H02AB09 - Hydrocortisone

S - Sensory organs

S01 - Ophthalmologicals

S01B - Antiinflammatory agents

S01BA - Corticosteroids, plain

S01BA02 - Hydrocortisone

S - Sensory organs

S01 - Ophthalmologicals

S01C - Antiinflammatory agents and antiinfectives in combination

S01CB - Corticosteroids/antiinfectives/mydriatics in combination

S01CB03 - Hydrocortisone

S - Sensory organs

S02 - Otologicals

S02B - Corticosteroids

S02BA - Corticosteroids

S02BA01 - Hydrocortisone

5.5 Absorption, Distribution and Excretion

Absorption

Oral hydrocortisone at a dose of 0.2-0.3mg/kg/day reached a mean C_max of 32.69nmol/L with a mean AUC of 90.63h\*nmol/L A 0.4-0.6mg/kg/day dose reached a mean C_max of 70.81nmol/L with a mean AUC of 199.11h\*nmol/L. However, the pharmacokinetics of hydrocortisone can vary by 10 times from patient to patient. Topical hydrocortisone cream is 4-19% bioavailable[8546995] with a T_max of 24h. Hydrocortisone retention enemas are have a bioavailability of 0.810 for slow absorbers and 0.502 in rapid absorbers. Slow absorbers take up hydrocortisone at a rate of 0.3610.255/h while fast absorbers take up hydrocortisone at a rate of 1.050.255/h. A 20mg IV dose of hydrocortisone has an AUC of 1163277ng\*h/mL.

Route of Elimination

Corticosteroids are eliminated predominantly in the urine. However, data regarding the exact proportion is not readily available.

Volume of Distribution

Total hydrocortisone has a volume of distribution of 39.82L, while the free fraction has a volume of distribution of 474.38L.

Clearance

Total hydrocortisone by the oral route has a mean clearance of 12.85L/h, while the free fraction has a mean clearance of 235.78L/h. A 20mg IV dose of hydrocortisone has a clearance of 18.24.2L/h.

Following percutaneous penetration of a topical corticosteroid, the drug that is systemically absorbed probably follows the metabolic pathways of systemically administered corticosteroids. Corticosteroids usually are metabolized in the liver and excreted by the kidneys. Some topical corticosteroids and their metabolites are excreted in bile. /Topical corticosteroids/

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 3525

Topical application of corticosteroids to the mucosa of the genitourinary or lower intestinal tract may result in substantial systemic absorption of the drugs. In healthy individuals, as much as 30-90% of rectally administered hydrocortisone as a retention enema may be absorbed. Greater amounts of hydrocortisone may be absorbed rectally if the intestinal mucosa is inflamed.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 3525

Following topical application of a corticosteroid to most areas of normal skin, only minimal amounts of the drug reach the dermis and subsequently the systemic circulation; however, absorption is markedly increased when the skin has lost its keratin layer and can be increased by inflammation and/or diseases of the epidermal barrier (e.g., psoriasis, eczema). The drugs are absorbed to a greater degree from the scrotum, axilla, eyelid, face, and scalp than from the forearm, knee, elbow, palm, and sole. Even after washing the area being treated, prolonged absorption of the corticosteroid occurs, possibly because the drug is retained in the stratum corneum. /Topical corticosteroids/

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 3525

Percutaneous penetration of corticosteroids varies among individual patients and can be increased by the use of occlusive dressings, by increasing the concentration of the corticosteroid, and by using different vehicles. The use of an occlusive dressing with hydrocortisone for 96 hours substantially enhances percutaneous penetration of the drug; however, such use for up to 24 hours does not appear to alter penetration of topically applied hydrocortisone.

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 3525

For more Absorption, Distribution and Excretion (Complete) data for HYDROCORTISONE (15 total), please visit the HSDB record page.

5.6 Metabolism/Metabolites

Hydrocortisone is metabolised to 6-beta hydrocortisol via CYP3A, 5-beta tetrahydrocortisol via 3-oxo-5-beta-steroid 4-dehydrogenase, 5-alpha tetrahydrocortisol via 3-oxo-5-alpha-steroid 4-dehydrogenase 2, cortisone via Corticosteroid 11-beta-dehydrogenase isozyme 1 and Corticosteroid 11-beta-dehydrogenase isozyme 2, and glucuronide products. Cortisone is further metabolized to tetrahydrocortisone and dihydrocortisol.

A study was made of the absorption of exogenous hydrocortisone and formation of its metabolites in isolated liver of intact and exposed rats in conditions of recirculating perfusion. It was shown that the absorption of the hormone by the liver of irradiated rats was greatly lowered but the content of most metabolites found in the perfused medium of irradiated liver increased as compared to the control. It is suggested that irradiation inhibits subsequent transformations of the hydrocortisone metabolism products.

PMID:4001319 Litskevich LA, Dokshina GA; Radiobiologiia 25 (2): 200-3 (1985)

Subcellular distribution of (3)H-hydrocortisone and its metabolites in the liver and kidney of intact and alloxan diabetic rats was investigated. Ten minutes after the administration of this hormone several metabolites (mostly tetrahydrocortisol) and the native hormone were found in liver cytosol, microsomes, mitochondria and nuclei, the relative content of individual compounds in various subcellular fractions being different. In liver mitochondria, microsomes and nuclei of alloxan diabetic rats the concentration of tetrahydrocortisol was decreased, while that of native hormone was increased as compared to normal animals. It was suggested that such changes found in diabetic animals may be one of the causes of increased sensitivity of transcription and translation processes to glucocorticoids. In kidney cytosol and microsomes of intact rats cortisone and tetrahydrocortisol were found. In diabetic animals, however, the concentration of tetrahydrocortisol increased, while that of cortisone was undetectable.

PMID:3259502 Minchenko AG, Tronjko ND; Endocrinol Exp 22 (1): 19-28 (1988)

5.7 Biological Half-Life

Total hydrocortisone via the oral route has a half life of 2.15h while the free fraction has a half life of 1.39h. A 20mg IV dose of hydrocortisone has a terminal half life of 1.90.4h.

... After IV administration, hydrocortisone was eliminated with a total body clearance of 18 L/hr and a half-life of 1.7 hr.

PMID:2050835 Derendorf H et al; J Clin Pharmacol 31 (5): 473-6 (1991)

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.

Following topical application, corticosteroids produce anti-inflammatory, antipruritic, and vasoconstrictor actions. The activity of the drugs is thought to result at least in part from binding with a steroid receptor. Corticosteroids decrease inflammation by stabilizing leukocyte lysosomal membranes, preventing release of destructive acid hydrolases from leukocytes; inhibiting macrophage accumulation in inflamed areas; reducing leukocyte adhesion to capillary endothelium; reducing capillary wall permeability and edema formation; decreasing complement components; antagonizing histamine activity and release of kinin from substrates; reducing fibroblast proliferation, collagen deposition, and subsequent scar tissue formation; and possibly by other mechanisms as yet unknown. Corticosteroids, especially the fluorinated corticosteroids, have antimitotic activity on cutaneous fibroblasts and the epidermis. /Corticosteroids/

McEvoy, G.K. (ed.). American Hospital Formulary Service. AHFS Drug Information. American Society of Health-System Pharmacists, Bethesda, MD. 2007., p. 3525

Reactive oxygen species (ROS) generation by polymorphonuclear leukocytes (PMNL) and mononuclear cells (MNC) is inhibited following the intravenous administration of hydrocortisone. This is associated with a parallel decrease in intranuclear NFkappaB, known to modulate inflammatory responses including ROS generation. Plasma levels of interleukin-10 (IL-10), an anti-inflammatory and immunosuppressive cytokine produced by TH2 cells, are also increased after hydrocortisone administration. In this study, we have investigated the effect of hydrocortisone on p47(phox) subunit, a key component of nicotinamide adenine dinucleotide phosphate (NADPH) oxidase, in MNC and the pharmacodynamics of this effect with ROS generation and plasma IL-10 levels /were investigated/. p47(phox) subunit protein levels in MNC showed a progressive decrease after hydrocortisone administration. It reached a nadir at 4 hours and increased thereafter to a baseline level at 24 hours. ROS generation also decreased, reached a nadir between 2 and 4 hours, and returned to a baseline level at 24 hours. IL-10 concentrations increased, peaked at 4 hours, and reverted to the baseline levels at 24 hours. In conclusion, p47(phox) subunit suppression may contribute to the inhibition of ROS generation in MNC after hydrocortisone administration. This suppression occurs in parallel with the suppression of NFkappaB and an increase in IL-10 plasma levels. Therefore, it would appear that the decrease in intranuclear NFkappaB and an increase in IL-10 may cause the inhibitory modulation on p47(phox) subunit and ROS generation by MNC following hydrocortisone and other glucocorticoids.

PMID:11319715 Dandona P et al; Metabolism 50 (5): 548-52 (2001)

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EUROAPI

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Euroapi France

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Hydrocortisone

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Pharmacia And Upjohn Co Llc Wholly O...

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04

Symbiotec Pharmalab Private Ltd

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Hydrocortisone Hemisuccinate Usp

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Farmabios Spa

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Hydrocortisone Hemisuccinate

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Hydrocortisone Sodium Phosphate

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Hydrocortisone sodium phosphate

Registration Number : 220MF10093

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EUROAPI FRANCE

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Pfizer Inc.

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Curia Spain S. A. U.

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Henan Lihua Pharmaceutical Co. , Lt...

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Hydrocortisone Hydrogen Succinate EP

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Hydrocortisone USP/EP/BP

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Maharshi Pharma Chem

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EUROAPI

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hydrocortisone

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HYDROCORTISONE

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02

Symbiotec Pharmalab Private Limited

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Sanofi chimie

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Hovione Farmaciencia Sa

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EUROAPI

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Hydrocortisone

About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...

EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Thanks to its excellent R&D skills and six manufacturing facilities across Europe, EUROAPI guarantees API manufacturing of the highest quality to its clients in over 80 countries. Its strong innovation and R&D skills helps it to speed the development of more complex molecule segments through CDMO operations. It also offers experience in supply, regulation and quality. EUROAPI employs 3,350 people and is listed on Euronext.

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Pfizer CentreOne

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About the Company : Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates.
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Pfizer CentreOne® is an altogether different global contract development and manufacturing organization (CDMO), and a leading supplier of specialty APIs and intermediates. Backed by Pfizer resources, we’ve been delivering technical expertise, regulatory support and long-term supply for over 40 years. With 35+ sites across six continents, our expansive network allows us to securely and efficiently guide complex compounds from development through commercial manufacture. For more information, visit http://www.pfizercentreone.com

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Symbiotec Pharmalab

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Hydrocortisone

About the Company : Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable...

Symbiotec, a leading API manufacturing company based in Indore, Central India, specializes in Cortico-Steroids and Steroid-Hormone APIs. Since 1995, their focus on R&D, sustainable operations, and innovation has driven their commitment to improving global healthcare access. With a state-of-the-art manufacturing facility inaugurated in 2004, Symbiotec has become a trusted provider in the industry. Their certifications including WHO-GMP, ISO, US FDA, and EU GMP showcase their dedication to quality and excellence. Over two decades, they've maintained their position through adaptability, efficiency, and competitive pricing.

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Axplora

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Hydrocortisone Hemisuccinate Hydrate

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Axplora, created from the merger of Farmabios, Novasep & PharmaZell, is a leading API manufacturing partner to the world’s leading pharma & biotech companies, delivering top-quality APIs on time & at scale, to the highest industry standards. It is dedicated to helping pharma companies make critical medicines safely to benefit patients. Leveraging our combined expertise & manufacturing capabilities across 9 industrial sites in the EU & India & an R&D facility in the USA, it offers CDMO services for small molecule APIs & biopharmaceuticals to innovators as well as APIs that address lifestyle-induced respiratory, inflammatory & liver diseases.

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Rochem International Inc

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Established in 1994, Rochem is a distributor of pharmaceutical, food, nutritional and animal health ingredients to some of the largest companies in the world. It sources high-quality ingredients manufactured in China. Headquartered in the Hauppauge, New York, Rochem has 16 offices spread across the globe to cater to the needs of its customers. Rochem’s operations are fully cGMP compliant and has been audited by the USFDA as well as several multinational organizations. It also trains and audits its partners to ensure all of their technologies and systems are FDA-compliant.

06

Gonane Pharma

India

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Hydrocortisone Aceponate

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Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncology products. The company's core strength lies in its dedicated team, and its promoters bring over 25 years of experience in manufacturing, promoting products, and managing audits for regulated markets such as the EU, Mexico, China, Korea, and Russia. GONANE PHARMA is actively engaged in discussions with Japanese customers and anticipates further expansion into additional markets.

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Pharm-RX Chemical

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Hydrocortisone

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Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritional supplement, and food industries. The company maintains an exceptionally selective approach to its suppliers, personally visiting manufacturers overseas to ensure the highest standards. The sustained growth of Pharm-Rx can be attributed to its steadfast commitment to three core values: quality ingredients, competitive pricing, and unparalleled customer service.

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HRV Global Life Sciences

India

CPHI Middle east

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Hydrocortisone

About the Company : HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It...

HRV Global is a leading global manufacturer, seller & exporter of a wide range of APIs, advanced intermediates, pellets, food grade chemicals, food additives & food ingredients. It offers services such as sourcing, manufacturing & supply, helping partners enter new markets worldwide. Its strong partnerships with major players in the pharma and food additive industries help HRV Global effectively promote projects and products. HRV Global represents over 30 large Indian drugmakers, primarily targeting Europe, the US & the Middle East markets. Headquartered in India, HRV Global has offices in the US, Switzerland, Dubai, Lithuania & Turkey.

09

Bioquim

Spain

Medlab Asia & Asia Health

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Bioquim: An European GMP-certified company manufacturing bulk APIs, specializing in sterile lyophilization and chemical synthesis.

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Hydrocortisone Sodium Phosphate

About the Company : Bioquim is a European company specializing in bulk oral & sterile APIs for the pharmaceutical industry. With over 40 years of experience, we offer high-quality corticosteroids, pep...

Bioquim is a European company specializing in bulk oral & sterile APIs for the pharmaceutical industry. With over 40 years of experience, we offer high-quality corticosteroids, peptides, amino acids, penicillin derivatives, non-penicillin antibiotics, and HPAPIs for human & veterinary markets. We adhere to stringent GMP and operate state-of-the-art facilities with advanced technology. Bioquim also provides Custom Synthesis & Contract Manufacturing services, delivering tailored solutions backed by our expertise in chemical synthesis & lyophilization of sterile APIs. Trust Bioquim for your API needs & experience our commitment to quality.

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Jin Dun Medical

China

Medlab Asia & Asia Health

Not Confirmed

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Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725042600,"product":"PHARMACEUTICALS APIS: HYDROCORTISONE SODIUM SUCCINATE FOR INJECTION USP FOR MANUFACTURERS USE (HYDROCORTISONE","address":"385\/2, GRAM PIGDEMBER,NEAR HOTEL MASHAL, RAU","city":"INDORE, M.P.","supplier":"SYMBIOTEC PHARMALAB","supplierCountry":"INDIA","foreign_port":"BUENOS AIRES","customer":"TO THE ORDER","customerCountry":"ARGENTINA","quantity":"30.00","actualQuantity":"30","unit":"KGS","unitRateFc":"360","totalValueFC":"10240.1","currency":"USD","unitRateINR":28630.719999999998,"date":"31-Aug-2024","totalValueINR":"858921.6","totalValueInUsd":"10240.1","indian_port":"Bombay Air","hs_no":"29372900","bill_no":"3625236","productDescription":"API","marketType":"LESS REGULATED MARKET","country":"ARGENTINA","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"385\/2, GRAM PIGDEMBER,NEAR HOTEL MASHAL, RAU, INDORE, M.P.","customerAddress":""},{"dataSource":"API 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Export","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1727289000,"product":"RAW MATERIAL - HYDROCORTISONE ACETATE USP (UNIT 1 KG) (QTY 10 KGS)","address":"321,3RD FLOOR,HARI OM PLAZA,","city":"MUMBAI, MAHARASHTRA","supplier":"STANMARC ENTERPRISE","supplierCountry":"INDIA","foreign_port":"MATADI","customer":"TO,","customerCountry":"CONGO D REPULIC","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"449","totalValueFC":"4441.7","currency":"USD","unitRateINR":37222.091,"date":"26-Sep-2024","totalValueINR":"372220.91","totalValueInUsd":"4441.7","indian_port":"JNPT","hs_no":"29372100","bill_no":"4362658","productDescription":"API","marketType":"REGULATED MARKET","country":"CONGO D REPULIC","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"321,3RD FLOOR,HARI OM PLAZA,, MUMBAI, MAHARASHTRA","customerAddress":""},{"dataSource":"API 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PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"B.M.CHEMIE","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"325","totalValueFC":"16454.3","currency":"USD","unitRateINR":"24407.5","date":"18-Aug-2021","totalValueINR":"1220375","totalValueInUsd":"16454.3","indian_port":"BOMBAY AIR","hs_no":"29372100","bill_no":"5098397","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"108, MARINE CHEMBERS, 43, NEW MARINE LINES, BEHIND SNDT COLLEGE,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q3","strtotime":1632508200,"product":"HYDROCORTISONE SODIUM PHOSPHATE","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"CRYSTAL PHARMA S.A.U","supplierCountry":"SPAIN","foreign_port":"#N\/A","customer":"CIPLA","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"5000","totalValueFC":"5057.3","currency":"USD","unitRateINR":"372000","date":"25-Sep-2021","totalValueINR":"372000","totalValueInUsd":"5057.3","indian_port":"BOMBAY AIR","hs_no":"29372100","bill_no":"5587067","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2021","qtr":"Q4","strtotime":1638383400,"product":"HYDROCORTISONE IP \/EP\/USP","address":"304, Town Centre, Andheri Kurla Road, Andheri East","city":"MUMBAI","supplier":"TIANJIN JINJIN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"MAC-CHEM PRODUCTS (INDIA) PVT.LTD","customerCountry":"INDIA","quantity":"800.00","actualQuantity":"800","unit":"KGS","unitRateFc":"310","totalValueFC":"246927.6","currency":"USD","unitRateINR":"23281","date":"02-Dec-2021","totalValueINR":"18624800","totalValueInUsd":"246927.6","indian_port":"BOMBAY AIR","hs_no":"29372100","bill_no":"6498911","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"","customerAddress":"304, Town Centre, Andheri Kurla Road, Andheri East"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1641148200,"product":"HYDROCORTISONE SODIUM PHOSPHATE","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"#N\/A","customer":"CIPLA","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"5000","totalValueFC":"5178.3","currency":"USD","unitRateINR":"385750","date":"03-Jan-2022","totalValueINR":"385750","totalValueInUsd":"5178.3","indian_port":"BOMBAY AIR","hs_no":"29372100","bill_no":"6935943","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"#N\/A","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1645986600,"product":"HYDROCORTISONE ACETATE IP","address":"1209,1210,1211,CABIN A,12TH FLOOR, ,UNIVERSAL MAJESTIC,","city":"P L LOKHANDE MARG CHEMBUR,MAHARASHT","supplier":"TIANJIN TIANYAO PHARMACEUTICALS CO., LTD.","supplierCountry":"CHINA","foreign_port":"NA","customer":"AQUATIC REMEDIES PVT LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"425","totalValueFC":"21559.9","currency":"USD","unitRateINR":"32321.3","date":"28-Feb-2022","totalValueINR":"1616062.5","totalValueInUsd":"21559.9","indian_port":"BOMBAY AIR","hs_no":"29379090","bill_no":"7672176","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"1209,1210,1211,CABIN A,12TH FLOOR, ,UNIVERSAL MAJESTIC,"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q1","strtotime":1646159400,"product":"HYDROCORTISONE SODIUM PHOSPHATE","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"5000","totalValueFC":"24944.4","currency":"USD","unitRateINR":"380250","date":"02-Mar-2022","totalValueINR":"1901250","totalValueInUsd":"24944.4","indian_port":"BOMBAY AIR","hs_no":"29372100","bill_no":"7702494","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1665685800,"product":"HYDROCORTISONE ACETATE IP2018\/EP10","address":"4TH FLR., SAMRUDDHI VENTURE PARK,M IDC CENTRAL ROAD, MAROL","city":"ANDHERI EAST MUMBAI MAHARASHTRA,MAH","supplier":"HENAN LIHUA PHARMACEUTICAL","supplierCountry":"CHINA","foreign_port":"NA","customer":"GALENTIC PHARMA PVT LTD","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"375","totalValueFC":"18787.8","currency":"USD","unitRateINR":"30918.8","date":"14-Oct-2022","totalValueINR":"1545937.5","totalValueInUsd":"18787.8","indian_port":"BOMBAY AIR","hs_no":"29372100","bill_no":"2874971","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"4TH FLR., SAMRUDDHI VENTURE PARK,M IDC CENTRAL ROAD, MAROL"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1677609000,"product":"HYDROCORTISONE SODIUM PHOSPHATE, BP12 AS PER INV.","address":"NO 2 BP ESTATE NATIONAL HIGHWAY,NO 8 CHHANI","city":"VADODARA,GUJARAT","supplier":"CURIA","supplierCountry":"SPAIN","foreign_port":"NA","customer":"GOWRIE RESEARCH PRIVATE ","customerCountry":"INDIA","quantity":"0.20","actualQuantity":"0.2","unit":"KGS","unitRateFc":"12000","totalValueFC":"2663","currency":"EUR","unitRateINR":"1095183.8","date":"01-Mar-2023","totalValueINR":"219036.75","totalValueInUsd":"2663","indian_port":"AHMEDABAD AIR","hs_no":"29372100","bill_no":"4858133","productDescription":"API","marketType":"REGULATED MARKET","country":"SPAIN","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"NO 2 BP ESTATE NATIONAL HIGHWAY,NO 8 CHHANI"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713724200,"product":"HYDROCORTISONE BASE","address":"PLOT NO.2516 2518,","city":"DIST: VALSAD\/GUJARAT","supplier":"QIYING INDUSTRIAL CO. LTD.","supplierCountry":"CHINA","foreign_port":"TIANJIN","customer":"ARIHANTANAM LIFECARE PRIVATE LIMITED","customerCountry":"INDIA","quantity":"300.00","actualQuantity":"300","unit":"KGS","unitRateFc":"225","totalValueFC":"68221.6","currency":"USD","unitRateINR":"18990","date":"22-Apr-2024","totalValueINR":"5697000","totalValueInUsd":"68221.6","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"3140574","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"TIANJIN","supplierAddress":"TRUST COMPANY COMPLEXAJEL TAKE ROADAJELT TAKE ISLAND MAJURO CHINA","customerAddress":"PLOT NO.2516 2518,"}]

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country	Total Quantity (KGS)	Average Price (USD/KGS)	Number of Transactions

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Drugs in Development

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

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FDA Orange Book

01

STRIDES PHARMA

India

AES 2024

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code :

HYDROCORTISONE

Brand Name : HYDROCORTISONE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2007-07-16

Application Number : 40761

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

02

STRIDES PHARMA

India

AES 2024

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code :

HYDROCORTISONE

Brand Name : HYDROCORTISONE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2007-07-16

Application Number : 40761

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

03

STRIDES PHARMA

India

AES 2024

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code :

HYDROCORTISONE

Brand Name : HYDROCORTISONE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2007-07-16

Application Number : 40761

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

04

STRIDES PHARMA

India

AES 2024

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

HYDROCORTISONE

Brand Name : HYDROCORTISONE

Dosage Form : TABLET;ORAL

Dosage Strength : 5MG

Approval Date : 2017-04-27

Application Number : 207029

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

05

STRIDES PHARMA

India

AES 2024

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

HYDROCORTISONE

Brand Name : HYDROCORTISONE

Dosage Form : TABLET;ORAL

Dosage Strength : 10MG

Approval Date : 2017-04-27

Application Number : 207029

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

06

STRIDES PHARMA

India

AES 2024

Not Confirmed

Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

Contact Supplier

India

Virtual Booth

Digital Content

RLD : No

TE Code : AB

HYDROCORTISONE

Brand Name : HYDROCORTISONE

Dosage Form : TABLET;ORAL

Dosage Strength : 20MG

Approval Date : 2017-04-27

Application Number : 207029

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

07

DERMIK LABS

France

AES 2024

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

RLD : Yes

TE Code :

HYDROCORTISONE

Brand Name : HYTONE

Dosage Form : OINTMENT;TOPICAL

Dosage Strength : 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 80474

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

08

DERMIK LABS

France

AES 2024

Not Confirmed

Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Contact Supplier

France

Virtual Booth

Digital Content

RLD : Yes

TE Code :

HYDROCORTISONE

Brand Name : HYTONE

Dosage Form : OINTMENT;TOPICAL

Dosage Strength : 2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1982-01-01

Application Number : 80474

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

09

ALLERGAN HERBERT

U.S.A

AES 2024

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Contact Supplier

U.S.A

Virtual Booth

Digital Content

RLD : No

TE Code :

HYDROCORTISONE

Brand Name : AEROSEB-HC

Dosage Form : AEROSOL;TOPICAL

Dosage Strength : 0.5%

Approval Date : 1982-01-01

Application Number : 85805

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

10

ALLERGAN HERBERT

U.S.A

AES 2024

Not Confirmed

Contact Supplier

U.S.A

Virtual Booth

Digital Content

RLD : Yes

TE Code :

HYDROCORTISONE

Brand Name : PENECORT

Dosage Form : SOLUTION;TOPICAL

Dosage Strength : 1%

Approval Date : 1984-06-06

Application Number : 88214

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Virtual Booth

Digital Content

Website

Corporate PDF

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Europe

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Canada

01

AURO PHARMA INC

Canada

Pharma, Lab & Chemical Expo

Not Confirmed

02

AURO PHARMA INC

Pharma, Lab & Chemical Expo

Not Confirmed

06

ODAN LABORATORIES LTD

Canada

Country

Pharma, Lab & Chemical Expo

Not Confirmed

10

VIRBAC AH, INC.

Country

Pharma, Lab & Chemical Expo

Not Confirmed

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Australia

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - SUSPENSION/DROPS;OTIC - EQ 0.2% BASE...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 0.2% BASE;1%

USFDA APPLICATION NUMBER - 20805

DOSAGE - CREAM;TOPICAL - 5%;1%

USFDA APPLICATION NUMBER - 22436

DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;E...DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 50168

DOSAGE - CREAM;TOPICAL - 1%

USFDA APPLICATION NUMBER - 80693

DOSAGE - TABLET;ORAL - 10MG

USFDA APPLICATION NUMBER - 8697

DOSAGE - TABLET;ORAL - 20MG

USFDA APPLICATION NUMBER - 8697

DOSAGE - TABLET;ORAL - 5MG

USFDA APPLICATION NUMBER - 8697

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