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    Chemistry

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    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
    Hydrocortisone
    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 Weight 362.5 g/mol
    Molecular Formula C21H30O5
    XLogP31.6
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count2
    Exact Mass362.20932405 g/mol
    Monoisotopic Mass362.20932405 g/mol
    Topological Polar Surface Area94.8 Ų
    Heavy Atom Count26
    Formal Charge0
    Complexity684
    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 36  
    Drug NameAcetasol hc
    PubMed HealthAcetic Acid/Hydrocortisone (Into the ear)
    Drug ClassesAnti-Infective/Anti-Inflammatory Combination
    Active IngredientAcetic acid, glacial; hydrocortisone
    Dosage FormSolution/drops
    RouteOtic
    Strength1%; 2%
    Market StatusPrescription
    CompanyActavis Mid Atlantic

    2 of 36  
    Drug NameAla-cort
    PubMed HealthHydrocortisone
    Drug ClassesAnti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
    Active IngredientHydrocortisone
    Dosage FormCream
    RouteTopical
    Strength1%
    Market StatusPrescription
    CompanyCrown Labs

    3 of 36  
    Drug NameAla-scalp
    PubMed HealthHydrocortisone (On the skin)
    Drug ClassesCorticosteroid, Intermediate, Corticosteroid, Weak
    Active IngredientHydrocortisone
    Dosage FormLotion
    RouteTopical
    Strength2%
    Market StatusPrescription
    CompanyCrown Labs

    4 of 36  
    Drug NameAnusol hc
    PubMed HealthHydrocortisone (By mouth)
    Drug ClassesAnti-Inflammatory, Endocrine-Metabolic Agent, Immune Suppressant
    Active IngredientHydrocortisone
    Dosage FormCream
    RouteTopical
    Strength2.5%
    Market StatusPrescription
    CompanySalix Pharms

    5 of 36  
    Drug NameColocort
    PubMed HealthHydrocortisone Enema (Rectal)
    Drug ClassesAnti-Inflammatory, Gastrointestinal Agent
    Drug LabelHydrocortisone 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 IngredientHydrocortisone
    Dosage FormEnema
    RouteRectal
    Strength100mg/60ml
    Market StatusPrescription
    CompanyPaddock

    6 of 36  
    Drug NameCortef
    PubMed HealthHydrocortisone (Rectal)
    Drug ClassesAnti-Inflammatory, Hemorrhoidal Anti-Inflammatory
    Drug LabelCORTEF 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 IngredientHydrocortisone
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    7 of 36  
    Drug NameCortenema
    PubMed HealthNeomycin, Polymyxin B, and Hydrocortisone
    Drug ClassesAdrenal Glucocorticoid, Aminoglycoside/Corticosteroid Combination, Anti-Infective/Anti-Inflammatory Combination, Neomycin
    Drug LabelHydrocortisone 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 IngredientHydrocortisone
    Dosage FormEnema
    RouteRectal
    Strength100mg/60ml
    Market StatusPrescription
    CompanyAni Pharms

    8 of 36  
    Drug NameCortifoam
    PubMed HealthHydrocortisone
    Drug ClassesAnti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
    Active IngredientHydrocortisone acetate
    Dosage FormAerosol, metered
    RouteRectal
    Strength10%
    Market StatusPrescription
    CompanyMeda Pharms

    9 of 36  
    Drug NameCortisporin
    PubMed HealthHydrocortisone
    Drug ClassesAnti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
    Active IngredientHydrocortisone acetate; polymyxin b sulfate; Hydrocortisone; Bacitracin zinc; hydrocortisone; neomycin sulfate
    Dosage FormSolution/drops; Suspension/drops; Ointment; Cream
    RouteTopical; Otic
    Strength400 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 StatusPrescription
    CompanyMonarch Pharms; Citron Pharma

    10 of 36  
    Drug NameHydrocortisone
    Active IngredientHydrocortisone
    Dosage FormOintment; Enema; Tablet; Cream; Lotion
    RouteRectal; Oral; Topical
    Strength1%; 5mg; 10mg; 2.5%; 100mg/60ml; 20mg
    Market StatusPrescription
    CompanyVintage Pharms; Amedra Pharms; Taro; Fougera; Lyne; Fougera Pharms; Teva Pharms; Actavis Mid Atlantic; Vintage; Perrigo New York

    11 of 36  
    Drug NameHydrocortisone and acetic acid
    Drug LabelTopical 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 IngredientAcetic acid, glacial; hydrocortisone
    Dosage FormSolution/drops
    RouteOtic
    Strength1%; 2%
    Market StatusPrescription
    CompanyTaro; Vintage

    12 of 36  
    Drug NameHydrocortisone in absorbase
    Active IngredientHydrocortisone
    Dosage FormOintment
    RouteTopical
    Strength1%
    Market StatusPrescription
    CompanyCarolina Medcl

    13 of 36  
    Drug NameHydro-rx
    PubMed HealthAcetic Acid/Hydrocortisone (Into the ear)
    Drug ClassesAnti-Infective/Anti-Inflammatory Combination
    Drug LabelGlucocorticoids 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 IngredientHydrocortisone
    Dosage FormPowder
    RouteFor rx compounding
    Strength100%
    Market StatusPrescription
    CompanyX Gen Pharms

    14 of 36  
    Drug NameNutracort
    Active IngredientHydrocortisone
    Dosage FormLotion
    RouteTopical
    Strength2.5%
    Market StatusPrescription
    CompanyDow Pharm

    15 of 36  
    Drug NameStie-cort
    Active IngredientHydrocortisone
    Dosage FormLotion
    RouteTopical
    Strength2.5%
    Market StatusPrescription
    CompanyPerrigo

    16 of 36  
    Drug NameSynacort
    Active IngredientHydrocortisone
    Dosage FormCream
    RouteTopical
    Strength1%; 2.5%
    Market StatusPrescription
    CompanyMedicis

    17 of 36  
    Drug NameTexacort
    Active IngredientHydrocortisone
    Dosage FormSolution
    RouteTopical
    Strength2.5%
    Market StatusPrescription
    CompanyMission Pharma

    18 of 36  
    Drug NameVosol hc
    Active IngredientAcetic acid, glacial; hydrocortisone
    Dosage FormSolution/drops
    RouteOtic
    Strength1%; 2%
    Market StatusPrescription
    CompanyHi Tech Pharma

    19 of 36  
    Drug NameAcetasol hc
    PubMed HealthAcetic Acid/Hydrocortisone (Into the ear)
    Drug ClassesAnti-Infective/Anti-Inflammatory Combination
    Active IngredientAcetic acid, glacial; hydrocortisone
    Dosage FormSolution/drops
    RouteOtic
    Strength1%; 2%
    Market StatusPrescription
    CompanyActavis Mid Atlantic

    20 of 36  
    Drug NameAla-cort
    PubMed HealthHydrocortisone
    Drug ClassesAnti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
    Active IngredientHydrocortisone
    Dosage FormCream
    RouteTopical
    Strength1%
    Market StatusPrescription
    CompanyCrown Labs

    21 of 36  
    Drug NameAla-scalp
    PubMed HealthHydrocortisone (On the skin)
    Drug ClassesCorticosteroid, Intermediate, Corticosteroid, Weak
    Active IngredientHydrocortisone
    Dosage FormLotion
    RouteTopical
    Strength2%
    Market StatusPrescription
    CompanyCrown Labs

    22 of 36  
    Drug NameAnusol hc
    PubMed HealthHydrocortisone (By mouth)
    Drug ClassesAnti-Inflammatory, Endocrine-Metabolic Agent, Immune Suppressant
    Active IngredientHydrocortisone
    Dosage FormCream
    RouteTopical
    Strength2.5%
    Market StatusPrescription
    CompanySalix Pharms

    23 of 36  
    Drug NameColocort
    PubMed HealthHydrocortisone Enema (Rectal)
    Drug ClassesAnti-Inflammatory, Gastrointestinal Agent
    Drug LabelHydrocortisone 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 IngredientHydrocortisone
    Dosage FormEnema
    RouteRectal
    Strength100mg/60ml
    Market StatusPrescription
    CompanyPaddock

    24 of 36  
    Drug NameCortef
    PubMed HealthHydrocortisone (Rectal)
    Drug ClassesAnti-Inflammatory, Hemorrhoidal Anti-Inflammatory
    Drug LabelCORTEF 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 IngredientHydrocortisone
    Dosage FormTablet
    RouteOral
    Strength5mg; 10mg; 20mg
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    25 of 36  
    Drug NameCortenema
    PubMed HealthNeomycin, Polymyxin B, and Hydrocortisone
    Drug ClassesAdrenal Glucocorticoid, Aminoglycoside/Corticosteroid Combination, Anti-Infective/Anti-Inflammatory Combination, Neomycin
    Drug LabelHydrocortisone 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 IngredientHydrocortisone
    Dosage FormEnema
    RouteRectal
    Strength100mg/60ml
    Market StatusPrescription
    CompanyAni Pharms

    26 of 36  
    Drug NameCortifoam
    PubMed HealthHydrocortisone
    Drug ClassesAnti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
    Active IngredientHydrocortisone acetate
    Dosage FormAerosol, metered
    RouteRectal
    Strength10%
    Market StatusPrescription
    CompanyMeda Pharms

    27 of 36  
    Drug NameCortisporin
    PubMed HealthHydrocortisone
    Drug ClassesAnti-Inflammatory, Corticosteroid, Intermediate, Corticosteroid, Weak, Endocrine-Metabolic Agent, Gastrointestinal Agent, Hemorrhoidal Anti-Inflammatory, Hydrocortisone, Immune Suppressant
    Active IngredientHydrocortisone acetate; polymyxin b sulfate; Hydrocortisone; Bacitracin zinc; hydrocortisone; neomycin sulfate
    Dosage FormSolution/drops; Suspension/drops; Ointment; Cream
    RouteTopical; Otic
    Strength400 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 StatusPrescription
    CompanyMonarch Pharms; Citron Pharma

    28 of 36  
    Drug NameHydrocortisone
    Active IngredientHydrocortisone
    Dosage FormOintment; Enema; Tablet; Cream; Lotion
    RouteRectal; Oral; Topical
    Strength1%; 5mg; 10mg; 2.5%; 100mg/60ml; 20mg
    Market StatusPrescription
    CompanyVintage Pharms; Amedra Pharms; Taro; Fougera; Lyne; Fougera Pharms; Teva Pharms; Actavis Mid Atlantic; Vintage; Perrigo New York

    29 of 36  
    Drug NameHydrocortisone and acetic acid
    Drug LabelTopical 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 IngredientAcetic acid, glacial; hydrocortisone
    Dosage FormSolution/drops
    RouteOtic
    Strength1%; 2%
    Market StatusPrescription
    CompanyTaro; Vintage

    30 of 36  
    Drug NameHydrocortisone in absorbase
    Active IngredientHydrocortisone
    Dosage FormOintment
    RouteTopical
    Strength1%
    Market StatusPrescription
    CompanyCarolina Medcl

    31 of 36  
    Drug NameHydro-rx
    PubMed HealthAcetic Acid/Hydrocortisone (Into the ear)
    Drug ClassesAnti-Infective/Anti-Inflammatory Combination
    Drug LabelGlucocorticoids 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 IngredientHydrocortisone
    Dosage FormPowder
    RouteFor rx compounding
    Strength100%
    Market StatusPrescription
    CompanyX Gen Pharms

    32 of 36  
    Drug NameNutracort
    Active IngredientHydrocortisone
    Dosage FormLotion
    RouteTopical
    Strength2.5%
    Market StatusPrescription
    CompanyDow Pharm

    33 of 36  
    Drug NameStie-cort
    Active IngredientHydrocortisone
    Dosage FormLotion
    RouteTopical
    Strength2.5%
    Market StatusPrescription
    CompanyPerrigo

    34 of 36  
    Drug NameSynacort
    Active IngredientHydrocortisone
    Dosage FormCream
    RouteTopical
    Strength1%; 2.5%
    Market StatusPrescription
    CompanyMedicis

    35 of 36  
    Drug NameTexacort
    Active IngredientHydrocortisone
    Dosage FormSolution
    RouteTopical
    Strength2.5%
    Market StatusPrescription
    CompanyMission Pharma

    36 of 36  
    Drug NameVosol hc
    Active IngredientAcetic acid, glacial; hydrocortisone
    Dosage FormSolution/drops
    RouteOtic
    Strength1%; 2%
    Market StatusPrescription
    CompanyHi 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

    H02AB09

    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 Cmax of 32.69nmol/L with a mean AUC of 90.63h\*nmol/L A 0.4-0.6mg/kg/day dose reached a mean Cmax 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 Tmax 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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    Hydrocortisone, Non-micronised, micronised

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    R1-CEP 2002-220 - Rev 02
    Valid
    Chemical
    2023-03-23
    335
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    PHARMACIA & UPJOHN COMPANY LLC Kala...

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    Hydrocortisone, Non-micronised, micronised

    Certificate Number : R1-CEP 2002-220 - Rev 02

    Status : Valid

    Issue Date : 2023-03-23

    Type : Chemical

    Substance Number : 335

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    SYMBIOTEC PHARMALAB PRIVATE LIMITED...

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    CEP 2018-054 - Rev 02
    Valid
    Chemical
    2024-04-15
    335
    Symbiotec Pharmalab

    05

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    Hydrocortisone, Micronised

    Certificate Number : CEP 2018-054 - Rev 02

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    Issue Date : 2024-04-15

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    Substance Number : 335

    Symbiotec Pharmalab

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    BAYER AG Leverkusen DE

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    R1-CEP 2000-099 - Rev 02
    Valid
    Chemical
    2017-03-01
    335
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    BAYER AG Leverkusen DE

    Germany
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    BAYER AG Leverkusen DE

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    Hydrocortisone, Micro 20

    Certificate Number : R1-CEP 2000-099 - Rev 02

    Status : Valid

    Issue Date : 2017-03-01

    Type : Chemical

    Substance Number : 335

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    HENAN LIHUA PHARMACEUTICAL CO., LTD...

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    Hydrocortisone

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    R0-CEP 2022-264 - Rev 00
    Valid
    Chemical
    2023-08-22
    335
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    07

    HENAN LIHUA PHARMACEUTICAL CO., LTD...

    China
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    HENAN LIHUA PHARMACEUTICAL CO., LTD...

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    Hydrocortisone

    Certificate Number : R0-CEP 2022-264 - Rev 00

    Status : Valid

    Issue Date : 2023-08-22

    Type : Chemical

    Substance Number : 335

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    Pharmacia & Upjohn Company Kalamazo...

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    Hydrocortisone

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    R0-CEP 2000-354 - Rev 00
    Withdrawn by Holder
    TSE
    2001-10-24
    2006-10-24
    335
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    Pharmacia & Upjohn Company Kalamazo...

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    Hydrocortisone

    Certificate Number : R0-CEP 2000-354 - Rev 00

    Status : Withdrawn by Holder

    Issue Date : 2001-10-24

    Type : TSE

    Substance Number : 335

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    SHANDONG XINHUA PHARMACEUTICAL CO.,...

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    Hydrocortisone

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    R0-CEP 2019-176 - Rev 00
    Valid
    Chemical
    2021-10-06
    335
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    09

    SHANDONG XINHUA PHARMACEUTICAL CO.,...

    China
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    SHANDONG XINHUA PHARMACEUTICAL CO.,...

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    Hydrocortisone

    Certificate Number : R0-CEP 2019-176 - Rev 00

    Status : Valid

    Issue Date : 2021-10-06

    Type : Chemical

    Substance Number : 335

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    TIANJIN JINJIN PHARMACEUTICAL CO., ...

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    Hydrocortisone, Process B, micronised, non-micronised

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    R0-CEP 2021-048 - Rev 01
    Valid
    Chemical
    2022-05-05
    335
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    10

    TIANJIN JINJIN PHARMACEUTICAL CO., ...

    China
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    01

    EUROAPI FRANCE

    France
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Hydrocortisone sodium phosphate

    Registration Number : 220MF10093

    Registrant's Address : 15 rue Traversie(')re 75012 Paris France

    Initial Date of Registration : 2008-03-28

    Latest Date of Registration : 2022-06-22

    EUROAPI Compnay Banner

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    02

    EUROAPI FRANCE

    France
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Hydrocortisone

    Registration Number : 218MF10377

    Registrant's Address : 15 rue Traversie(')re 75012 Paris France

    Initial Date of Registration : 2006-03-20

    Latest Date of Registration : 2019-11-27

    EUROAPI Compnay Banner

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    03

    EUROAPI FRANCE

    France
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Hydrocortisone

    Registration Number : 228MF10090

    Registrant's Address : 15 rue Traversie(')re 75012 Paris France

    Initial Date of Registration : 2016-04-15

    Latest Date of Registration : 2021-03-05

    EUROAPI Compnay Banner

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    04

    Pfizer Inc.

    U.S.A
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    Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

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    Hydrocortisone

    Registration Number : 222MF10138

    Registrant's Address : 235 East 42nd Street, New York, NY 10017

    Initial Date of Registration : 2010-04-14

    Latest Date of Registration : 2023-03-23

    Pfizer centreOne

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    05

    Curia Spain S. A. U.

    U.S.A
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    Curia Spain S. A. U.

    U.S.A
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    Hydrocortisone Sodium Phosphate

    Registration Number : 217MF10680

    Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

    Initial Date of Registration : 2005-10-07

    Latest Date of Registration : 2015-09-03

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    06

    Henan Lihua Pharmaceutical Co. , Lt...

    China
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    Henan Lihua Pharmaceutical Co. , Lt...

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    Hydrocortisone

    Registration Number : 226MF10036

    Registrant's Address : Middle of Huanghe Street, Anyang Hi-Tech Industry Development Zone, Henan, China

    Initial Date of Registration : 2014-02-05

    Latest Date of Registration : 2017-08-08

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    EU WC

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    Symbiotec Pharmalab

    India
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    Hydrocortisone Hydrogen Succinate EP

    Date of Issue : 2022-09-30

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161

    Address of the Firm : 385/2, Pigdamber, Rau, Indore-453 331, MP, India

    Symbiotec Pharmalab

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    02

    Symbiotec Pharmalab

    India
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    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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    Hydrocortisone Hemisuccinate BP/USP

    Date of Issue : 2022-07-05

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161A2

    Address of the Firm : 385/2, Pigdamber, Rau, Indore-453 331, MP, India

    Symbiotec Pharmalab

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    03

    Symbiotec Pharmalab

    India
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    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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    Hydrocortisone BP/EP/USP

    Date of Issue : 2022-07-05

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0161A2

    Address of the Firm : 385/2, Pigdamber, Rau, Indore-453 331, MP, India

    Symbiotec Pharmalab

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    04

    Symbiotec Pharmalab

    India
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    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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    Hydrocortisone USP/EP/BP

    Date of Issue : 2022-08-31

    Valid Till : 2025-07-02

    Written Confirmation Number : WC-0162

    Address of the Firm : Plot No. 5, 6, 7 & 8 Special Economic Zone, Phase II, Pithampur, Dist: Dhar, MP-...

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    05

    Maharshi Pharma Chem

    India
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    Maharshi Pharma Chem

    India
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    Hydrocortisone Acetate USP/BP

    Date of Issue : 2021-08-13

    Valid Till : 2023-09-24

    Written Confirmation Number : WC-0485A3

    Address of the Firm : Block No 203, Vaso-Alindra Road, PO Alindra-387510, Tal-Matar Dist. Kheda, Gujar...

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    KDMF

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    EUROAPI

    France
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    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    hydrocortisone

    Registrant Name : Novartis Korea Ltd.

    Registration Date : 2023-07-25

    Registration Number : 20230725-209-J-1524

    Manufacturer Name : EUROAPI France

    Manufacturer Address : 4 Lieu Dit La Paterie, Vertolaye, 63480, France

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    02

    Henan Lihua Pharmaceutical

    China
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    Henan Lihua Pharmaceutical

    China
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    hydrocortisone

    Registrant Name : Toru Corporation

    Registration Date : 2021-09-14

    Registration Number : 20210711-209-J-980(2)

    Manufacturer Name : Henan Lihua Pharmaceutical C...

    Manufacturer Address : Middle of Huanghe Street, Anyang Hi-Tech Industry Development Zone, China

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    03

    Henan Lihua Pharmaceutical

    China
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    Henan Lihua Pharmaceutical

    China
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    hydrocortisone

    Registrant Name : Daeshin Pharmaceutical Co., Ltd.

    Registration Date : 2021-08-12

    Registration Number : 20210711-209-J-980(1)

    Manufacturer Name : Henan Lihua Pharmaceutical C...

    Manufacturer Address : Middle of Huanghe Street, Anyang Hi-Tech Industry Development Zone, China

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    04

    Henan Lihua Pharmaceutical

    China
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    Henan Lihua Pharmaceutical

    China
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    hydrocortisone

    Registrant Name : Donggu Biopharmaceutical Co., Ltd.

    Registration Date : 2021-11-15

    Registration Number : 20210711-209-J-980(3)

    Manufacturer Name : Henan Lihua Pharmaceutical C...

    Manufacturer Address : Middle of Huanghe Street, Anyang Hi-Tech Industry Development Zone, China

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    Henan Lihua Pharmaceutical

    China
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    China
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    hydrocortisone

    Registrant Name : Hiple Co., Ltd.

    Registration Date : 2022-02-24

    Registration Number : 20210711-209-J-980(4)

    Manufacturer Name : Henan Lihua Pharmaceutical C...

    Manufacturer Address : Middle of Huanghe Street, Anyang Hi-Tech Industry Development Zone, China

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    06

    Henan Lihua Pharmaceutical

    China
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    China
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    hydrocortisone

    Registrant Name : Insung Trading Co., Ltd.

    Registration Date : 2021-07-11

    Registration Number : 20210711-209-J-980

    Manufacturer Name : Henan Lihua Pharmaceutical C...

    Manufacturer Address : Middle of Huanghe Street, Anyang Hi-Tech Industry Development Zone, China

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    07

    Pfizer Inc

    U.S.A
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    Pfizer Inc

    U.S.A
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    hydrocortisone

    Registrant Name : Bansen Co., Ltd.

    Registration Date : 2022-03-10

    Registration Number : 20220310-209-J-1237

    Manufacturer Name : Pharmacia & Upjohn Company L...

    Manufacturer Address : 7000 Portage Road, Kalamazoo, Michigan 49001 USA

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    08

    Shandong Xinhua Pharmaceutical

    China
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    Shandong Xinhua Pharmaceutical

    China
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    hydrocortisone

    Registrant Name : Ace Biopharm Co., Ltd.

    Registration Date : 2020-12-17

    Registration Number : 20201217-209-J-539

    Manufacturer Name : Shandong Xinhua Pharmaceutic...

    Manufacturer Address : Hutian Chemical Industrial Zone, Zibo, Shandong, PR China

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    09

    Tianjin Jinjin Pharmaceutical Co Lt...

    China
    BioFlorida Conference
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    Tianjin Jinjin Pharmaceutical Co Lt...

    China
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    hydrocortisone

    Registrant Name : Sanil Pharma Co., Ltd.

    Registration Date : 2021-07-05

    Registration Number : 20210705-209-J-740

    Manufacturer Name : Tianjin Jinjin Pharmaceutica...

    Manufacturer Address : Industrial Zone of Zhangjiawo Town, Xiqing District Tianjin, China@Industrial Zone of...

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    10

    Zhejiang Xianju Pharmaceutical Co. ...

    China
    BioFlorida Conference
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    Zhejiang Xianju Pharmaceutical Co. ...

    China
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    hydrocortisone

    Registrant Name : Kukjeon Pharmaceutical Co., Ltd.

    Registration Date : 2018-02-05

    Registration Number : 20180205-209-J-16

    Manufacturer Name : Zhejiang Xianju Pharmaceutic...

    Manufacturer Address : No.3 Donghai 4th Avenue, Zhejiang Toumen Port Economic Development Zone, Linhai, Zhej...

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    NDC API

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    01

    EUROAPI France

    France
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    DDL Conference
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    HYDROCORTISONE

    NDC Package Code : 82298-101

    Start Marketing Date : 2011-02-07

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    EUROAPI Compnay Banner

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    02

    Symbiotec Pharmalab Private Limited

    India
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    CPhI India 2024
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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    HYDROCORTISONE

    NDC Package Code : 22552-0037

    Start Marketing Date : 2013-06-04

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT

    Symbiotec Pharmalab

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    03

    Sanofi chimie

    France
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    BioFlorida Conference
    Not Confirmed
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

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    HYDROCORTISONE

    NDC Package Code : 50396-7004

    Start Marketing Date : 2011-02-07

    End Marketing Date : 2026-07-26

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    Sanofi Company Banner

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    04

    Valdepharm

    Luxembourg
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    BOS Manchester
    Attending
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    Virtual BoothFareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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    HYDROCORTISONE HEMISUCCINATE

    NDC Package Code : 24823-907

    Start Marketing Date : 2010-08-30

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

    Fareva Company Banner

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    05

    Fagron Inc

    Netherlands
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    Fagron Inc

    Netherlands
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    HYDROCORTISONE

    NDC Package Code : 51552-0020

    Start Marketing Date : 2004-09-01

    End Marketing Date : 2025-06-13

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT FOR HUMAN P...

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    06

    Henan Lihua Pharmaceutical Co Ltd

    China
    BioFlorida Conference
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    Henan Lihua Pharmaceutical Co Ltd

    China
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    BioFlorida Conference
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    • fda
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    Virtual Booth 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.
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    HYDROCORTISONE

    NDC Package Code : 64958-0062

    Start Marketing Date : 2003-01-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    07

    Jiangsu Lianhuan Pharmaceutical Co....

    China
    BioFlorida Conference
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    Jiangsu Lianhuan Pharmaceutical Co....

    China
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    BioFlorida Conference
    Not Confirmed
    • fda
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    HYDROCORTISONE

    NDC Package Code : 81918-001

    Start Marketing Date : 2023-03-17

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    08

    Kalchem International inc

    U.S.A
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    Kalchem International inc

    U.S.A
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    BioFlorida Conference
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    Virtual Booth 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.
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    HYDROCORTISONE

    NDC Package Code : 60592-310

    Start Marketing Date : 2019-12-01

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1g/g)

    Marketing Category : BULK INGREDIENT FOR HUMAN P...

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    09

    McKinley Resources Inc.

    U.S.A
    BioFlorida Conference
    Not Confirmed
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    McKinley Resources Inc.

    U.S.A
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    BioFlorida Conference
    Not Confirmed
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    HYDROCORTISONE

    NDC Package Code : 86014-200

    Start Marketing Date : 2019-06-07

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    10

    Pharmacia and Upjohn Company LLC

    U.S.A
    BioFlorida Conference
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    Pharmacia and Upjohn Company LLC

    U.S.A
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    BioFlorida Conference
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    Virtual Booth 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.
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    HYDROCORTISONE HEMISUCCINATE

    NDC Package Code : 0009-5086

    Start Marketing Date : 2014-07-03

    End Marketing Date : 2024-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Listed Suppliers

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    01

    EUROAPI

    France
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    DDL Conference
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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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.
    EUROAPI Compnay Banner

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    02

    Pfizer CentreOne

    U.S.A
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    BioFlorida Conference
    Not Confirmed
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    Virtual BoothPfizer CentreOne is a global CDMO and a leading supplier of Specialty APIs.

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    Hydrocortisone

    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.
    ...

    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
    Pfizer centreOne

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    03

    Symbiotec Pharmalab

    India
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    CPhI India 2024
    Exhibiting
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

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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.
    Symbiotec Pharmalab

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    04

    Axplora

    Germany
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    BOS Manchester
    Attending
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    Virtual BoothAxplora- The partner of choice for complex APIs.

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    Hydrocortisone Hemisuccinate Hydrate

    About the Company : 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-qual...

    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.
    Axplora CB

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    05

    Rochem International Inc

    U.S.A
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    Suppliers Night Expo
    Attending
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    Virtual BoothRochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

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    Hydrocortisone

    About the Company : 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-quali...

    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.
    Rochem

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    06

    Gonane Pharma

    India
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    CPhI India 2024
    Booth #2.A34
    • fda
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    Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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    Hydrocortisone Aceponate

    About the Company : Gonane Pharma, is a contract pharmaceutical company located in Gujarat, India, specializing in the manufacturing and marketing of Corticosteroids, Hormones, Antivirals, and Oncolog...

    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.
    Gonane Pharma

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    07

    Pharm-RX Chemical

    U.S.A
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    BioFlorida Conference
    Not Confirmed
    • fda
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    Virtual BoothPharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.

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    Hydrocortisone

    About the Company : 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, nutritio...

    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.
    Pharm RX

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    08

    HRV Global Life Sciences

    India
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    CPhI India 2024
    Booth #2.D38
    • fda
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    Virtual BoothHRV Global Life Sciences - Market Expansion Leader in Pharmaceuticals.

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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.
    HRV Global Life Sciences

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    09

    Bioquim

    Spain
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    Not Confirmed
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    Virtual BoothBioquim: 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.
    Bioquim

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    10

    Curia

    U.S.A
    BioFlorida Conference
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    Curia

    U.S.A
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    Virtual Booth 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.
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    Hydrocortisone Sodium Phosphate

    About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...

    Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. From early discovery and development through manufacturing and commercialization, our suite of custom solutions allows us to tailor every engagement to your precise needs, whether that’s an independent project or an opportunity that cuts across the drug continuum.
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    API Reference Price

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LIMITED","customerCountry":"INDIA","quantity":"600.00","actualQuantity":"600","unit":"KGS","unitRateFc":"290","totalValueFC":"175807.2","currency":"USD","unitRateINR":"24084.5","date":"29-Jun-2023","totalValueINR":"14450699.91","totalValueInUsd":"175807.2","indian_port":"BOMBAY AIR","hs_no":"29372100","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"3RD FLOOR, 304, TOWN CENTRE ANDHERI KURLA ROAD, MAROL, ANDHERI"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691346600,"product":"HYDROCORTISONE IP2018\/USP20200501","address":"108, MARINE CHEMBERS, 43, NEW ,MARINE LINES, BEHIND SNDT COLLEGE, ,","city":"Mumbai","supplier":"HENAN LIHUA PHARMACEUTICALS CO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"B M CHEMIE","customerCountry":"INDIA","quantity":"50.00","actualQuantity":"50","unit":"KGS","unitRateFc":"345","totalValueFC":"17374.2","currency":"USD","unitRateINR":"28496.5","date":"07-Aug-2023","totalValueINR":"1439215.8","totalValueInUsd":"17374.2","indian_port":"SAHAR AIR","hs_no":"29372100","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"108, MARINE CHEMBERS, 43, NEW ,MARINE LINES, BEHIND SNDT COLLEGE, ,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701714600,"product":"HYDROCORTISONE (NOT FOR MEDICINAL USE)","address":"BLOCK NO.203,VASO-ALI NDRA ROAD,","city":"DIST.KHEDA GUJARAT","supplier":"KHONSU INTERNATIONAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"MAHARSHI PHARMA CHEM ","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"255","totalValueFC":"25762.5","currency":"USD","unitRateINR":"21445.5","date":"05-Dec-2023","totalValueINR":"2144550","totalValueInUsd":"25762.5","indian_port":"Ahmedabad Air","hs_no":"29372100","bill_no":"9072239","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Non Pharma","supplierPort":"BEIJING","supplierAddress":"HENGSHENG BUILDING, NO. 6 LIUJIANGROAD, HEXI DIST. TIANJIN 300061CHINA CN","customerAddress":"BLOCK NO.203,VASO-ALI NDRA ROAD,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705948200,"product":"HYDROCORTISONE IP\/EP\/USP","address":"385\/2, GRAM PIGDEMBER,","city":"INDORE, M.P.","supplier":"TIANJIN JINJIN PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"SYMBIOTEC PHARMALAB","customerCountry":"INDIA","quantity":"6.10","actualQuantity":"6.1","unit":"KGS","unitRateFc":"320","totalValueFC":"1975.2","currency":"USD","unitRateINR":"26912","date":"23-Jan-2024","totalValueINR":"164163.2","totalValueInUsd":"1975.2","indian_port":"Bombay Air","hs_no":"29372100","bill_no":"9783272","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"8 OF JINGFU ROAD, INDUSTRIAL ZONE OF ZHANGJIAWAO TOWN, XIQING DISTRICT, TIANJIN , CHINA , , China","customerAddress":"385\/2, GRAM PIGDEMBER,"}]
    01-Feb-2021
    29-Oct-2024
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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

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    DOSAGE - CREAM;TOPICAL - 5%;1%

    USFDA APPLICATION NUMBER - 22436

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    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

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    DOSAGE - CREAM;TOPICAL - 1%

    USFDA APPLICATION NUMBER - 80693

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    DOSAGE - TABLET;ORAL - 10MG

    USFDA APPLICATION NUMBER - 8697

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    DOSAGE - TABLET;ORAL - 20MG

    USFDA APPLICATION NUMBER - 8697

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    DOSAGE - TABLET;ORAL - 5MG

    USFDA APPLICATION NUMBER - 8697

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    FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

    FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

    This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).  Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period.  Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.  
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    https://www.pharmacompass.com/radio-compass-blog/fda-s-june-2024-list-of-off-patent-off-exclusivity-drugs-sees-rise-in-cancer-hiv-treatments

    #PharmaFlow by PHARMACOMPASS
    11 Jul 2024
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    NEWS #PharmaBuzz

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    Eton Pharma's ET-400 NDA Accepted By FDA
    Eton Pharma's ET-400 NDA Accepted By FDA

    15 Jul 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/07/15/2913383/0/en/Eton-Pharmaceuticals-Announces-FDA-Acceptance-of-New-Drug-Application-for-ET-400-Hydrocortisone-Oral-Solution.html

    GLOBENEWSWIRE
    15 Jul 2024
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    Neurocrine To Present Phase 3 Data On CAH, Primary Adrenal Insufficiency
    Neurocrine To Present Phase 3 Data On CAH, Primary Adrenal Insufficiency

    28 May 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-new-phase-3-cahtalyst-data-in-adult-and-pediatric-patients-with-cah-and-study-data-for-modified-release-hydrocortisone-in-primary-adrenal-insufficiency-and-cah-at-endo-2024-302155663.html

    PR NEWSWIRE
    28 May 2024
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    Neurocrine Presents CAHtalyst, Hydrocortisone Data At ECE 2024
    Neurocrine Presents CAHtalyst, Hydrocortisone Data At ECE 2024

    14 May 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/neurocrine-biosciences-presented-baseline-data-from-the-cahtalyst-program-in-cah-and-study-data-for-modified-release-hydrocortisone-in-primary-adrenal-insufficiency-and-cah-at-ece-2024-302144009.html

    PR NEWSWIRE
    14 May 2024
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    Neurocrine CAHtalyst, Hydrocortisone Data At ECE 2024
    Neurocrine CAHtalyst, Hydrocortisone Data At ECE 2024

    07 May 2024

    // PR NEWSWIRE

    https://www.prnewswire.com/news-releases/neurocrine-biosciences-to-present-phase-3-baseline-characteristics-data-from-the-cahtalyst-program-of-crinecerfont-in-cah-and-data-for-modified-release-hydrocortisone-in-primary-adrenal-insufficiency-and-cah-studies-at-ece-2024-302137447.html

    PR NEWSWIRE
    07 May 2024
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    Eton NDA Submission to FDA for ET-400 Hydrocortisone Solution
    Eton NDA Submission to FDA for ET-400 Hydrocortisone Solution

    30 Apr 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com/news-release/2024/04/30/2872041/0/en/Eton-Pharmaceuticals-Announces-Submission-to-FDA-of-New-Drug-Application-for-ET-400-Hydrocortisone-Oral-Solution.html

    GLOBENEWSWIRE
    30 Apr 2024
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    Eton Awarded U.S. Patent for Proprietary Hydrocortisone Formulation
    Eton Awarded U.S. Patent for Proprietary Hydrocortisone Formulation

    21 Feb 2024

    // GLOBENEWSWIRE

    https://www.globenewswire.com//news-release/2024/02/21/2832591/0/en/Eton-Pharmaceuticals-Awarded-U-S-Patent-for-Proprietary-Hydrocortisone-Oral-Liquid-Formulation.html

    GLOBENEWSWIRE
    21 Feb 2024
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