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    Chemistry

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    Also known as: 53-86-1, Indometacin, Indocin, Indomethacine, Indometacine, Indocid
    Molecular Formula
    C19H16ClNO4
    Molecular Weight
    357.8  g/mol
    InChI Key
    CGIGDMFJXJATDK-UHFFFAOYSA-N
    FDA UNII
    XXE1CET956
    Indomethacin
    A non-steroidal anti-inflammatory agent (NSAID) that inhibits CYCLOOXYGENASE, which is necessary for the formation of PROSTAGLANDINS and other AUTACOIDS. It also inhibits the motility of POLYMORPHONUCLEAR LEUKOCYTES.
    Indomethacin is a Nonsteroidal Anti-inflammatory Drug. The mechanism of action of indomethacin is as a Cyclooxygenase Inhibitor.
    1 2D Structure

    Indomethacin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[1-(4-chlorobenzoyl)-5-methoxy-2-methylindol-3-yl]acetic acid
    2.1.2 InChI
    InChI=1S/C19H16ClNO4/c1-11-15(10-18(22)23)16-9-14(25-2)7-8-17(16)21(11)19(24)12-3-5-13(20)6-4-12/h3-9H,10H2,1-2H3,(H,22,23)
    2.1.3 InChI Key
    CGIGDMFJXJATDK-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(C2=C(N1C(=O)C3=CC=C(C=C3)Cl)C=CC(=C2)OC)CC(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    XXE1CET956
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Amuno

    2. Indocid

    3. Indocin

    4. Indomet 140

    5. Indometacin

    6. Indomethacin Hydrochloride

    7. Metindol

    8. Osmosin

    2.3.2 Depositor-Supplied Synonyms

    1. 53-86-1

    2. Indometacin

    3. Indocin

    4. Indomethacine

    5. Indometacine

    6. Indocid

    7. Metindol

    8. Reumacide

    9. Indomethazine

    10. Imbrilon

    11. Amuno

    12. Tannex

    13. Indomethacinum

    14. Artracin

    15. Artrinovo

    16. Artrivia

    17. Confortid

    18. Idomethine

    19. Indomecol

    20. Indoptic

    21. Indoptol

    22. Inflazon

    23. Infrocin

    24. Metartril

    25. Methazine

    26. Mikametan

    27. Sadoreum

    28. Dolovin

    29. Inacid

    30. Indacin

    31. Indomed

    32. Indomee

    33. Lausit

    34. Metacen

    35. Mobilan

    36. Indo-rectolmin

    37. Indo-tablinen

    38. Inteban Sp

    39. Durametacin

    40. Indometacyna

    41. Indometicina

    42. Mezolin

    43. Indo-lemmon

    44. Indometacinum

    45. 2-(1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1h-indol-3-yl)acetic Acid

    46. Indometacina

    47. Dolcidium

    48. Elmetacin

    49. Indomethine

    50. Indorektal

    51. Aconip

    52. Catlep

    53. Indoxen

    54. Vonum

    55. Indo-phlogont

    56. Chibro-amuno

    57. Rheumacin La

    58. 1h-indole-3-acetic Acid, 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-

    59. Osmosin

    60. Tivorbex

    61. 1-(p-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic Acid

    62. Ccris 3502

    63. 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methylindol-3-yl]acetic Acid

    64. Hsdb 3101

    65. 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-3-indoleacetic Acid

    66. Nci-c56144

    67. Mfcd00057095

    68. Indometacin [inn]

    69. Chembl6

    70. 1-(p-chlorobenzoyl)-2-methyl-5-methoxyindole-3-acetic Acid

    71. Imn

    72. Indole-3-acetic Acid, 1-(p-chlorobenzoyl)-5-methoxy-2-methyl-

    73. Nsc-757061

    74. 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1h-indole-3-acetic Acid

    75. [1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1h-indol-3-yl]acetic Acid

    76. Indocin Sr

    77. Xxe1cet956

    78. 2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methyl-1h-indol-3-yl}acetic Acid

    79. N-p-chlorbenzoyl-5-methoxy-2-methylindole-3-acetic Acid

    80. Mls000069402

    81. Indomethacin (indocid, Indocin)

    82. (1-p-chlorobenzoyl-5-methoxy-2-methylindol-3-yl)acetic Acid

    83. Chebi:49662

    84. 1-(p-chlorobenzoyl)-2-methoxy-3-methyl-1h-indole-3-acetic Acid

    85. Indomet 140

    86. Alpha-(1-(p-chlorobenzoyl)-2-methyl-5-methoxy-3-indolyl)acetic Acid

    87. {1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methyl-1h-indol-3-yl}acetic Acid

    88. Nsc-77541

    89. Cas-53-86-1

    90. 1-p-cloro-benzoil-5-metoxi-2-metilindol-3-acido Acetico

    91. Ncgc00015562-18

    92. Indmethacine

    93. Indomethancin

    94. 1-(p-chlorobenzoyl)-5-methoxy-2-methyl-3-indolylacetic Acid

    95. Arthrexin

    96. Bonidin

    97. Bonidon

    98. Indameth

    99. Indomod

    100. Miametan

    101. Smr000058195

    102. Indomo

    103. Flexin Continus

    104. Hicin

    105. Kwas 1-(p-chlorobenzoilo)-2-metylo-5-metoksy-3-indolilooctowy

    106. Chrono-indicid

    107. Chrono-indocid

    108. Indometacyna [polish]

    109. Dsstox_cid_740

    110. Bonidon Gel

    111. Indometicina [spanish]

    112. 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1h-indol-3-yl]acetic Acid

    113. Dolcidium Pl

    114. Indo-spray

    115. Indolar Sr

    116. Dsstox_rid_75763

    117. Dsstox_gsid_20740

    118. Indometacine [inn-french]

    119. Indometacinum [inn-latin]

    120. Indometacina [inn-spanish]

    121. 1-(4-chlorobenzoyl)-5-methoxy-2-methylindole-3-acetic Acid

    122. 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-indol-3-yl]acetic Acid

    123. 2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methylindol-3-yl}acetic Acid

    124. Indocin-sr

    125. Indochron E-r

    126. Indocin (tn)

    127. Aconip (tn)

    128. Indomethacin (usp)

    129. Flam

    130. Indocid (pharmaceutical)

    131. Sr-01000000014

    132. Einecs 200-186-5

    133. Indomethacin & Map-30

    134. Indomethacin [usan:usp]

    135. Unii-xxe1cet956

    136. Brn 0497341

    137. Indocollyre

    138. Indonol

    139. Innamit

    140. Inteban

    141. (1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1h-indol-3-yl)acetic Acid

    142. 2-{1-((4-chlorophenyl)carbonyl)-5-methoxy-2-methylindol-3-yl}acetic Acid

    143. 4kyk

    144. Indomethacin,(s)

    145. Prestwick_597

    146. Opera_id_56

    147. Spectrum_000919

    148. Tocris-1708

    149. 1z9h

    150. 1-(p-chlorbenzoyl)-5-methoxy-2-methylindol-3-essigsaeure [german]

    151. 1-p-cloro-benzoil-5-metoxi-2-metilindol-3-acido Acetico [spanish]

    152. Prestwick0_000272

    153. Prestwick1_000272

    154. Prestwick2_000272

    155. Prestwick3_000272

    156. Spectrum2_000970

    157. Spectrum3_000468

    158. Spectrum4_000018

    159. Spectrum5_000868

    160. Indometacin [jan]

    161. Indomethacin [mi]

    162. Lopac-i-7378

    163. Kwas 1-(p-chlorobenzoilo)-2-metylo-5-metoksy-3-indolilooctowy [polish]

    164. Molmap_000032

    165. Upcmld-dp023

    166. Ec 200-186-5

    167. I 7378

    168. Indometacin (jp17/inn)

    169. Indomethacin [hsdb]

    170. Indomethacin [usan]

    171. Schembl9300

    172. Indometacin [mart.]

    173. Indomethacin [vandf]

    174. Lopac0_000692

    175. Oprea1_686105

    176. Bspbio_000144

    177. Bspbio_001149

    178. Bspbio_002176

    179. Indometacin [who-dd]

    180. Indometacin [who-ip]

    181. Indomethacine Impurity Mixture

    182. Kbiogr_000395

    183. Kbiogr_000489

    184. Kbioss_000489

    185. Kbioss_001399

    186. 5-22-05-00239 (beilstein Handbook Reference)

    187. Mls001074194

    188. Mls006011845

    189. Bidd:gt0132

    190. Divk1c_000271

    191. Indomethacin [usp-rs]

    192. Spectrum1500350

    193. Spbio_000979

    194. Spbio_002363

    195. Bpbio1_000160

    196. Gtpl1909

    197. Dtxsid9020740

    198. Indomethacin, >=99% (tlc)

    199. Upcmld-dp023:001

    200. Bdbm17638

    201. Cgigdmfjxjatdk-uhfffaoysa-

    202. Hms500n13

    203. Kbio1_000271

    204. Kbio2_000489

    205. Kbio2_001399

    206. Kbio2_003057

    207. Kbio2_003967

    208. Kbio2_005625

    209. Kbio2_006535

    210. Kbio3_000897

    211. Kbio3_000898

    212. Kbio3_001396

    213. 1-(p-chlorbenzoyl)-5-methoxy-2-methylindol-3-essigsaeure

    214. Indomethacin - Cas 53-86-1

    215. Ninds_000271

    216. Bio2_000405

    217. Bio2_000885

    218. Hms1362i11

    219. Hms1568h06

    220. Hms1792i11

    221. Hms1920f21

    222. Hms1990i11

    223. Hms2089n19

    224. Hms2091n09

    225. Hms2095h06

    226. Hms2231j10

    227. Hms3262k05

    228. Hms3268a14

    229. Hms3374f07

    230. Hms3403i11

    231. Hms3414n13

    232. Hms3430l03

    233. Hms3649k17

    234. Hms3655o04

    235. Hms3678n11

    236. Hms3712h06

    237. Hms3747k21

    238. Hms3884e08

    239. Indometacin [ep Monograph]

    240. Indomethacin [orange Book]

    241. Indomethacin-d4(chlorobenzoyl-d4)

    242. Pharmakon1600-01500350

    243. Zinc601283

    244. Act02579

    245. Bcp18951

    246. Indomethacin, >=99.0% (tlc)

    247. Indomethacin [usp Monograph]

    248. Tox21_113109

    249. Tox21_201791

    250. Tox21_300266

    251. Tox21_500692

    252. Ac-532

    253. Ccg-40186

    254. Indometacinum [who-ip Latin]

    255. Nsc757061

    256. S1723

    257. Stl257874

    258. Akos000592893

    259. Tox21_113109_1

    260. At13679

    261. Db00328

    262. Indometacin 1.0 Mg/ml In Acetonitrile

    263. Ks-5255

    264. Lp00692

    265. Nsc 757061

    266. Sdccgsbi-0050670.p005

    267. Idi1_000271

    268. Idi1_002160

    269. Ncgc00015562-01

    270. Ncgc00015562-02

    271. Ncgc00015562-03

    272. Ncgc00015562-04

    273. Ncgc00015562-05

    274. Ncgc00015562-06

    275. Ncgc00015562-07

    276. Ncgc00015562-08

    277. Ncgc00015562-09

    278. Ncgc00015562-10

    279. Ncgc00015562-11

    280. Ncgc00015562-12

    281. Ncgc00015562-13

    282. Ncgc00015562-14

    283. Ncgc00015562-15

    284. Ncgc00015562-16

    285. Ncgc00015562-17

    286. Ncgc00015562-19

    287. Ncgc00015562-20

    288. Ncgc00015562-21

    289. Ncgc00015562-22

    290. Ncgc00015562-24

    291. Ncgc00015562-25

    292. Ncgc00015562-40

    293. Ncgc00024135-02

    294. Ncgc00024135-04

    295. Ncgc00024135-05

    296. Ncgc00024135-06

    297. Ncgc00024135-07

    298. Ncgc00024135-08

    299. Ncgc00024135-09

    300. Ncgc00024135-10

    301. Ncgc00024135-11

    302. Ncgc00024135-12

    303. Ncgc00024135-13

    304. Ncgc00024135-14

    305. Ncgc00024135-15

    306. Ncgc00254075-01

    307. Ncgc00259340-01

    308. Ncgc00261377-01

    309. Bi166166

    310. Bp-30207

    311. Hy-14397

    312. Nci60_041708

    313. Sbi-0050670.p004

    314. Acemetacin Impurity B [ep Impurity]

    315. Db-052413

    316. Ab00052022

    317. Eu-0100692

    318. Ft-0603227

    319. I0655

    320. Indomethacine 100 Microg/ml In Acetonitrile

    321. Sw196768-5

    322. Indomethacin, Meets Usp Testing Specifications

    323. Bim-0050670.0001

    324. C01926

    325. D00141

    326. S00108

    327. Ab00052022-20

    328. Ab00052022-21

    329. Ab00052022_23

    330. Ab00052022_24

    331. L000959

    332. Q409231

    333. Indomethacin, Antibiotic For Culture Media Use Only

    334. Q-201239

    335. Sr-01000000014-2

    336. Sr-01000000014-4

    337. Sr-01000000014-6

    338. Brd-k57222227-001-06-1

    339. Brd-k57222227-001-18-6

    340. Brd-k57222227-001-27-7

    341. Sr-01000000014-10

    342. Sr-01000000014-16

    343. Z56784896

    344. 1-p-chlorobenzoyl-2-methyl-5-methoxyindol-3-acetic Acid

    345. 1-(p-chlorobenzoyl)-2-methyl-5-methoxy-3-indoleacetic Acid

    346. 1-(p-chlorobenzoyl)-5-methoxy-2-methyl-3-indoleacetic Acid

    347. 1-(p-chlorobenzoyl)-5-methoxy-2-methylindol-3-acetic Acid

    348. 1-(4-chloro-benzoyl)-5-methoxy-2-methyl-3-indolyl-acetic Acid

    349. 1-(4-chlorobenzoyl)-2-methyl-5-methoxyindole-3-acetic Acid

    350. 1-(p-chlorobenzoyl)-2-methyl-5-methoxy-3-indole-acetic Acid

    351. 1-(p-chlorobenzoyl)-2-methyl-5-methoxy-3-indolylacetic Acid

    352. 1-(p-chlorobenzoyl)-5-methoxy-2-methyl-3-indol Acetic Acid

    353. 1-(p-chlorobenzoyl)-5-methoxy-2-methyl-indole-3-acetic Acid

    354. Indomethacin, European Pharmacopoeia (ep) Reference Standard

    355. N-(p-chlorobenzoyl)-2-methyl-5-methoxy-3-indolylacetic Acid

    356. Indomethacin, United States Pharmacopeia (usp) Reference Standard

    357. .alpha.-(1-(p-chlorobenzoyl)-2-methyl-5-methoxy-3-indolyl)acetic Acid

    358. [1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1h-indol-3-yl]acetic Acid #

    359. 1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1h-indole-3-acetic Acid & Map-30

    360. 1h-indole-3-acetic Acid, 1-(4-chlorobenzoyl)-5-methoxy-2-methyl- (9ci)

    361. 2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2 Methylindol-3-yl}acetic Acid

    362. 2-{1-[(4-chlorophenyl)carbonyl]-5-methoxy-2methylindol-3-yl}acetic Acid

    363. Indole-3-acetic Acid, 1-(p-chlorobenzoyl)-5-methoxy-2-methyl- (8ci)

    364. Indomethacin, Pharmaceutical Secondary Standard; Certified Reference Material

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 357.8 g/mol
    Molecular Formula C19H16ClNO4
    XLogP34.3
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count4
    Exact Mass357.0767857 g/mol
    Monoisotopic Mass357.0767857 g/mol
    Topological Polar Surface Area68.5 Ų
    Heavy Atom Count25
    Formal Charge0
    Complexity506
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    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 4  
    Drug NameIndocin
    PubMed HealthIndomethacin (Injection)
    Drug ClassesAnalgesic, Central Nervous System Agent
    Drug LabelSuspension INDOCINRegistered trademark of MERCK & CO., Inc., Whitehouse Station, NJ U.S.A. and licensed to Iroko Pharmaceuticals, LLC, Philadelphia, PA, U.S.A. All rights reserved for oral use contains 25mg of indomethacin per 5mL, alcohol 1%, an...
    Active IngredientIndomethacin sodium; Indomethacin
    Dosage FormSuspension; Injectable
    RouteInjection; Oral
    Strengtheq 1mg base/vial; 25mg/5ml
    Market StatusPrescription
    CompanyRecordati Rare; Iroko Pharms

    2 of 4  
    Drug NameIndomethacin
    PubMed HealthIndomethacin
    Drug ClassesAcetic Acid
    Drug LabelIndomethacin cannot be considered a simple analgesic and should not be used in conditions other than those recommended underINDICATION AND USAGE.Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorob...
    Active IngredientIndomethacin
    Dosage FormCapsule; Suppository; Injectable; Capsule, extended release
    RouteRectal; Injection; Oral
    Strengtheq 1mg base/vial; 25mg; 75mg; 50mg
    Market StatusPrescription
    CompanyMylan Pharms; Amneal Pharms; Avanthi; Hetero Labs Ltd Iii; Sun Pharm Inds; Sandoz; Watson Labs; Glenmark Generics; Ivax Sub Teva Pharms; Paddock; Fresenius Kabi Usa; Zydus Pharms Usa; G And W Labs; Mylan; Heritage Pharms

    3 of 4  
    Drug NameIndocin
    PubMed HealthIndomethacin (Injection)
    Drug ClassesAnalgesic, Central Nervous System Agent
    Drug LabelSuspension INDOCINRegistered trademark of MERCK & CO., Inc., Whitehouse Station, NJ U.S.A. and licensed to Iroko Pharmaceuticals, LLC, Philadelphia, PA, U.S.A. All rights reserved for oral use contains 25mg of indomethacin per 5mL, alcohol 1%, an...
    Active IngredientIndomethacin sodium; Indomethacin
    Dosage FormSuspension; Injectable
    RouteInjection; Oral
    Strengtheq 1mg base/vial; 25mg/5ml
    Market StatusPrescription
    CompanyRecordati Rare; Iroko Pharms

    4 of 4  
    Drug NameIndomethacin
    PubMed HealthIndomethacin
    Drug ClassesAcetic Acid
    Drug LabelIndomethacin cannot be considered a simple analgesic and should not be used in conditions other than those recommended underINDICATION AND USAGE.Indomethacin is a non-steroidal anti-inflammatory indole derivative designated chemically as 1-(4-chlorob...
    Active IngredientIndomethacin
    Dosage FormCapsule; Suppository; Injectable; Capsule, extended release
    RouteRectal; Injection; Oral
    Strengtheq 1mg base/vial; 25mg; 75mg; 50mg
    Market StatusPrescription
    CompanyMylan Pharms; Amneal Pharms; Avanthi; Hetero Labs Ltd Iii; Sun Pharm Inds; Sandoz; Watson Labs; Glenmark Generics; Ivax Sub Teva Pharms; Paddock; Fresenius Kabi Usa; Zydus Pharms Usa; G And W Labs; Mylan; Heritage Pharms

    4.2 Therapeutic Uses

    Anti-Inflammatory Agents, Non-Steroidal; Cardiovascular Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Tocolytic Agents

    National Library of Medicine's Medical Subject Headings. Indomethacin. Online file (MeSH, 2016). Available from, as of January 20, 2016: https://www.nlm.nih.gov/mesh/2016/mesh_browser/MBrowser.html

    /CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Indomethacin is included in the database.

    NIH/NLM; ClinicalTrials.Gov. Available from, as of March 17, 2016: https://clinicaltrials.gov/ct2/results?term=indomethacin&Search=Search

    Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Indomethacin has been found effective in active stages of the following: Moderate to severe rheumatoid arthritis including acute flares of chronic disease. Moderate to severe ankylosing spondylitis. Moderate to severe osteoarthritis. Acute painful shoulder (bursitis and/or tendinitis). Acute gouty arthritis. /Included in US product labeling/

    NIH; DailyMed. Current Medication Information for Indomethacin Capsule (Updated: August 12, 2015). Available from, as of March 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6422d983-a063-41ae-aa96-7ae2284cb123

    Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1,750 g when 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly, or pulmonary plethora on chest x-ray. /Included in US product label/

    NIH; DailyMed. Current Medication Information for Indomethacin Injection, Powder, Lyophilized, for Solution (Updated: April 29, 2014). Available from, as of March 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=30e38747-c553-4e2d-bc23-634e1dd90b8d

    For more Therapeutic Uses (Complete) data for INDOMETHACIN (19 total), please visit the HSDB record page.

    4.3 Drug Warning

    /BOXED WARNING/ Cardiovascular Risk. Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Indomethacin is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

    NIH; DailyMed. Current Medication Information for Indomethacin Capsule (Updated: August 12, 2015). Available from, as of March 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6422d983-a063-41ae-aa96-7ae2284cb123

    /BOXED WARNING/ Gastrointestinal Risk. Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.

    NIH; DailyMed. Current Medication Information for Indomethacin Capsule (Updated: August 12, 2015). Available from, as of March 28, 2016: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6422d983-a063-41ae-aa96-7ae2284cb123

    Indomethacin should be used with extreme caution and under close supervision in patients with a history of GI bleeding or peptic ulcer disease, and such patients should receive an appropriate ulcer preventive regimen. All patients considered at increased risk of potentially serious adverse GI effects (e.g., geriatric patients, those receiving high therapeutic dosages of NSAIAs, those with a history of peptic ulcer disease, those receiving anticoagulants or corticosteroids concomitantly) should be monitored closely for signs of ulcer perforation or GI bleeding. To minimize the potential risk of adverse GI effects, the lowest effective dosage and shortest possible duration of therapy should be employed. For patients who are at high risk, therapy other than an NSAIA should be considered.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2083

    Adverse dermatologic effects of indomethacin occur in less than 1% of patients and include pruritus, urticaria, rash, macular and morbilliform eruptions, erythema nodosum, petechiae or ecchymosis, exfoliative dermatitis, loss of hair, Stevens-Johnson syndrome, erythema multiforme, and toxic epidermal necrolysis.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2082

    For more Drug Warnings (Complete) data for INDOMETHACIN (43 total), please visit the HSDB record page.

    4.4 Drug Indication

    Oral indometacin is indicated for symptomatic management of moderate to severe rheumatoid arthritis including acute flares of chronic disease, moderate to severe ankylosing spondylitis, moderate to severe osteoarthritis, acute painful shoulder (bursitis and/or tendinitis) and acute gouty arthritis. Intravenous indometacin is indicated to induce closure of a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Indometacin is an NSAID with analgesic and antipyretic properties that exerts its pharmacological effects by inhibiting the synthesis of factors involved in pain, fever, and inflammation. Its therapeutic action does not involve pituitary-adrenal stimulation. Indometacin primarily works by suppressing inflammation in rheumatoid arthritis by providing relief of pain as well as reducing fever, swelling, and tenderness. This effectiveness has been demonstrated by a reduction in the extent of joint swelling, the average number of joints displaying symptoms of inflammation, and the severity of morning stiffness. Increased mobility was demonstrated by a decrease in total walking time and by improved functional capability seen as an increase in grip strength. In clinical trials, indometacin was shown to be effective in relieving the pain, reducing the fever, swelling, redness, and tenderness of acute gouty arthritis. Due to its pharmacological actions, the use of indometacin is associated with the risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, as well as gastrointestinal effects such as bleeding, ulceration, and perforation of the stomach or intestines. In a study of healthy individuals, acute oral and intravenous indometacin therapy resulted in a transiently diminished basal and CO2 stimulated cerebral blood flow; this effect disappeared in one study after one week of oral treatment. The clinical significance of this effect has not been established. Compared to other NSAIDs, it is suggested that indometacin is a more potent vasoconstrictor that is more consistent in decreasing cerebral blood flow and inhibiting CO2 reactivity. There have been studies that show indometacin directly inhibiting neuronal activity to some extent in the trigeminocervical complex after either superior salivatory nucleus or dural stimulation.

    5.2 MeSH Pharmacological Classification

    Anti-Inflammatory Agents, Non-Steroidal

    Anti-inflammatory agents that are non-steroidal in nature. In addition to anti-inflammatory actions, they have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. (See all compounds classified as Anti-Inflammatory Agents, Non-Steroidal.)

    Cardiovascular Agents

    Agents that affect the rate or intensity of cardiac contraction, blood vessel diameter, or blood volume. (See all compounds classified as Cardiovascular Agents.)

    Tocolytic Agents

    Drugs that prevent preterm labor and immature birth by suppressing uterine contractions (TOCOLYSIS). Agents used to delay premature uterine activity include magnesium sulfate, beta-mimetics, oxytocin antagonists, calcium channel inhibitors, and adrenergic beta-receptor agonists. The use of intravenous alcohol as a tocolytic is now obsolete. (See all compounds classified as Tocolytic Agents.)

    Cyclooxygenase Inhibitors

    Compounds or agents that combine with cyclooxygenase (PROSTAGLANDIN-ENDOPEROXIDE SYNTHASES) and thereby prevent its substrate-enzyme combination with arachidonic acid and the formation of eicosanoids, prostaglandins, and thromboxanes. (See all compounds classified as Cyclooxygenase Inhibitors.)

    Gout Suppressants

    Agents that increase uric acid excretion by the kidney (URICOSURIC AGENTS), decrease uric acid production (antihyperuricemics), or alleviate the pain and inflammation of acute attacks of gout. (See all compounds classified as Gout Suppressants.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    INDOMETHACIN
    5.3.2 FDA UNII
    XXE1CET956
    5.3.3 Pharmacological Classes
    Cyclooxygenase Inhibitors [MoA]; Nonsteroidal Anti-inflammatory Drug [EPC]; Anti-Inflammatory Agents, Non-Steroidal [CS]
    5.4 ATC Code

    M01AB01

    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

    C - Cardiovascular system

    C01 - Cardiac therapy

    C01E - Other cardiac preparations

    C01EB - Other cardiac preparations

    C01EB03 - Indometacin

    M - Musculo-skeletal system

    M01 - Antiinflammatory and antirheumatic products

    M01A - Antiinflammatory and antirheumatic products, non-steroids

    M01AB - Acetic acid derivatives and related substances

    M01AB01 - Indometacin

    M - Musculo-skeletal system

    M02 - Topical products for joint and muscular pain

    M02A - Topical products for joint and muscular pain

    M02AA - Antiinflammatory preparations, non-steroids for topical use

    M02AA23 - Indometacin

    S - Sensory organs

    S01 - Ophthalmologicals

    S01B - Antiinflammatory agents

    S01BC - Antiinflammatory agents, non-steroids

    S01BC01 - Indometacin

    5.5 Absorption, Distribution and Excretion

    Absorption

    Indometacin displays a linear pharmacokinetics profile where the plasma concentrations and area under the curve (AUC) are dose-proportional, whereas half-life (T1/2) and plasma and renal clearance are dose-dependent. Indometacin is readily and rapidly absorbed from the gastrointestinal tract. The bioavailability is virtually 100% following oral administration and about 90% of the dose is absorbed within 4 hours. The bioavailability is about 80-90% following rectal administration. The peak plasma concentrations following a single oral dose were achieved between 0.9 0.4 and 1.5 0.8 hours in a fasting state. Despite large intersubject variation as well using the same preparation, peak plasma concentrations are dose-proportional and averaged 1.54 0.76 g/mL, 2.65 1.03 g/mL, and 4.92 1.88 g/mL following 25 mg, 50 mg, and 75 mg single doses in fasting subjects, respectively. With a typical therapeutic regimen of 25 or 50 mg t.i.d., the steady-state plasma concentrations of indomethacin are an average 1.4 times those following the first dose.

    Route of Elimination

    Indometacin is eliminated via renal excretion, metabolism, and biliary excretion. It is also subject to enter the enterohepatic circulation through excretion of its glucuronide metabolites into bile followed by resorption of indometacin after hydrolysis. The extent of involvement in the enterohepatic circulation ranges from 27 to 115%. About 60 percent of an oral dosage is recovered in urine as drug and metabolites (26 percent as indomethacin and its glucuronide), and 33 percent in the feces (1.5 percent as indomethacin).

    Volume of Distribution

    The volume of distribution ranged from 0.34 to 1.57 L/kg following oral, intravenous, or rectal administration of single and multiple doses of indometacin in healthy individuals. Indometacin is distributed into the synovial fluid and is extensively bound to tissues. It has been detected in human breast milk and placenta. Although indometacin has been shown to cross the blood-brain barrier (BBB), its extensive plasma protein binding allows only the small fraction of free or unbound indometacin to diffuse across the BBB.

    Clearance

    In a clinical pharmacokinetic study, the plasma clearance of indometacin was reported to range from 1 to 2.5 mL/kg/min following oral administration.

    Patent ductus arteriosus (PDA) is a frequent complication in premature infants. Intravenous indomethacin is the standard mode of medical therapy and has been shown to be efficacious in closing the ductus. In our setup, oral indomethacin is being regularly used for medical treatment of suspected or clinically diagnosed PDA. Non-availability of the parenteral preparation and lack of information regarding the pharmacokinetic disposition of indomethacin in the premature infants in north Indian population led us to conduct this pharmacokinetic study with oral indomethacin. Twenty premature infants with gestational age 30.3 +/- 0.3 wk and birth weight, 1209.8 +/- 39.5 g; admitted to the neonatal unit of the Nehru Hospital, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh were enrolled in the study. Indomethacin was administered in a single oral dose of 0.2 mg/kg and blood samples were collected through an indwelling vascular catheter at 0 and 1, 2, 4, 8 and 12 hr after administration of indomethacin. Plasma indomethacin concentrations were assayed by spectrofluorometric technique. Large interindividual variability was observed for peak plasma concentrations (Cmax; 137.9 +/- 14.0 ng/mL), elimination half-life (t1/2 el; 21.4 +/- 1.7 hr) and area under the plasma concentrations time curve (AUC0-infinity;4172 +/- 303 ng.hr/mL) in these infants. Variables like birth weight, and sex did not have any sigiificant effect on indomethacin pharmacokinetics. However, the plasma t1/2 el of indomethacin was significantly (P < 0.01) larger in older infants (gestational age > 30 wk) in comparison to younger ones (gestational age < or = 30 wk). There was a negative correlation between gestational age and elimination t1/2 (r = -0.77). In conclusion, indomethacin pharmacokinetics showed a wide variability in premature infants. In view of these findings it can be suggested that infants of smaller gestational age are at greater risk of cumulative toxicity if more than one dose of indomethacin is given. With advancing age, metabolism as well as elimination of drug is faster that may require modification in indomethacin dose to achieve therapeutic response. These preliminary results may be of use in designing future pharmacokinetic studies of oral indomethacin in preterm neonates on a larger sample.

    PMID:14604305 Sharma PK et al; Indian J Med Res 117: 164-9 (2003)

    Approximately 33% or more of a 25-mg oral dose of indomethacin is excreted in feces principally as demethylated metabolites in their unconjugated forms; 1.5% of fecal drug excretion occurs as indomethacin. Indomethacin and its conjugates undergo enterohepatic circulation.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2087

    In one study in healthy fasting adults, peak plasma concentrations of indomethacin occurred in 0.5-2 hours and were about 0.8-2.5 ug/mL following a 25-mg oral dose, and 2.5-4 ug/mL following a 50-mg oral dose. When indomethacin was administered orally to healthy fasting individuals in 25-mg doses 3 times daily, mean steady-state plasma drug concentrations ranged from 0.39-0.63 ug/mL.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2087

    In premature neonates, absorption of oral indomethacin appears to be poor and incomplete; bioavailability is reportedly only about 20%. It has been suggested that poor oral absorption of the drug in premature neonates may result from abnormal pH-dependent diffusion and gastric motility and from lower gastric acid secretion. In neonates, gastric emptying time and motility are increased and peristalsis is irregular and unpredictable. In addition, the lack of solubility of the capsule form of indomethacin in aqueous media may present problems in drug delivery and absorption from extemporaneous preparations.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2086

    For more Absorption, Distribution and Excretion (Complete) data for INDOMETHACIN (20 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Indometacin undergoes hepatic metabolism involving glucuronidation, O-desmethylation, and N-deacylation. O-desmethyl-indomethacin, N-deschlorobenzoyl-indomethacin, and O-desmethyl-N-deschlorobenzoyl-indomethacin metabolites and their glucuronides are primarily inactive and have no pharmacological activity. Unconjugated metabolites are also detected in the plasma. Its high bioavailability indicates that indometacin is unlikely to be subject to the first-pass metabolism.

    Indomethacin is metabolized in the liver to its glucuronide conjugate and to desmethyl, desbenzoyl, and desmethyl-desbenzoyl metabolites and their glucuronides. These metabolites do not appear to possess anti-inflammatory activity. A portion of the drug is also N-deacylated by a nonmicrosomal system.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2087

    Indomethacin has known human metabolites that include (2S,3S,4S,5R)-6-[2-[1-(4-chlorobenzoyl)-5-methoxy-2-methylindol-3-yl]acetyl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid and O-Desmethylindomethacin.

    S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560

    5.7 Biological Half-Life

    Indometacin disposition from the plasma is reported to be biphasic, with a half-life of 1 hour during the initial phase and 2.611.2 hours during the second phase. Interindividual and intraindividual variations are possible due to the extensive and sporadic nature of the enterohepatic recycling and biliary discharge of the drug. The mean half-life of oral indomethacin is estimated to be about 4.5 hours. The disposition of intravenous indometacin in preterm neonates was shown to vary across premature infants. In neonates older than 7 days, the mean plasma half-life of intravenous indometacin was approximately 20 hours, ranging from 15 hours in infants weighing more than 1000 g and 21 hours in infants weighing less than 1000 g.

    Plasma concentrations of indomethacin have been studied in 5 healthy volunteers after single and multiple doses (25 mg intravenously [iv], 25, 50, and 100 mg orally, 100 mg rectally, and 25 mg three times daily [tid]. In 8 other normal subjects and in 5 patients a 50-mg oral dose of indomethacin was given and the indomethacin concentration was followed from 8 to 32 hr after dosing. ... The half-life of the beta-phase varied between 2.6 and 11.2 hr.

    PMID:1100305 Alvan G et al; Clin Pharmacol Ther 18 (3): 364-73 (1975)

    In premature neonates, the serum or plasma elimination half-life of indomethacin is inversely related to postnatal age. In a limited number of neonates, the mean plasma half-life of indomethacin has been reported to be about 20-28 hours in those receiving the drug during the first week of life, compared to about 12-19 hours in those receiving the drug after the first week. The elimination half-life in neonates may also be inversely related to body weight. In one study, the plasma indomethacin half-life showed considerable interindividual variation but averaged 21 hours in neonates weighing less than 1 kg and 15 hours in those weighing more than 1 kg. Total body clearance of indomethacin increases with increasing postnatal age. It was suggested that extensive enterohepatic circulation may commonly occur in premature neonates and may contribute to the relatively long half-life of elimination.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2087

    In studies in healthy adults or patients with rheumatoid arthritis, the disappearance of indomethacin from plasma appears to be biphasic with a half-life of approximately 1 hour during the initial phase and 2.6-11.2 hours during the second phase; variations in terminal plasma half-life may be due to individual differences in enterohepatic circulation of the drug. There appears to be no difference between plasma half-life in healthy adults and in rheumatoid arthritis patients.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2087

    In one study in healthy adults and patients with arthritis, the half-life for disappearance of indomethacin from synovial fluid was 9 hours.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2087

    ... Twenty premature infants with gestational age 30.3 +/- 0.3 wk and birth weight, 1209.8 +/- 39.5 g; admitted to the neonatal unit of the Nehru Hospital, Postgraduate Institute of Medical Education and Research (PGIMER), Chandigarh were enrolled in the study. Indomethacin was administered in a single oral dose of 0.2 mg/kg and blood samples were collected through an indwelling vascular catheter at 0 and 1, 2, 4, 8 and 12 hr after administration of indomethacin. Plasma indomethacin concentrations were assayed by spectrofluorometric technique. Large interindividual variability was observed for peak plasma concentrations (Cmax; 137.9 +/- 14.0 ng/mL), elimination half-life (t1/2 el; 21.4 +/- 1.7 hr) and area under the plasma concentrations time curve (AUC0-infinity;4172 +/- 303 ng.hr/mL) in these infants. Variables like birth weight, and sex did not have any sigiificant effect on indomethacin pharmacokinetics. However, the plasma t1/2 el of indomethacin was significantly (P < 0.01) larger in older infants (gestational age > 30 wk) in comparison to younger ones (gestational age

    PMID:14604305 Sharma PK et al; Indian J Med Res 117: 164-9 (2003)

    5.8 Mechanism of Action

    Indometacin is a nonspecific and reversible inhibitor of the cyclo-oxygenase (COX) enzyme or prostaglandin G/H synthase. There are two identified isoforms of COX: COX-1 is universally present in most body tissues and is involved in the synthesis of the prostaglandins and thromboxane A2, while COX-2 is expressed in response to injury or inflammation. Constitutively expressed, the COX-1 enzyme is involved in gastric mucosal protection, platelet, and kidney function by catalyzing the conversion of arachidonic acid to prostaglandin (PG) G2 and PGG2 to PGH2. COX-2 is constitutively expressed and highly inducible by inflammatory stimuli. It is found in the central nervous system, kidneys, uterus, and other organs. COX-2 also catalyzes the conversion of arachidonic acid to PGG2 and PGG2 to PGH2. In the COX-2-mediated pathway, PGH2 is further converted to PGE2 and PGI2 (also known as prostacyclin). PGE2 is involved in mediating inflammation, pain, and fever. Decreasing levels of PGE2 leads to reduced inflammatory reactions. Indometacin is known to inhibit both isoforms of COX, however, with greater selectivity for COX-1, which accounts for its increased adverse gastric effects relative to other NSAIDs. It binds to the enzyme's active site and prevents the interaction between the enzyme and its substrate, arachidonic acid. Indometacin, unlike other NSAIDs, also inhibits phospholipase A2, the enzyme responsible for releasing arachidonic acid from phospholipids. The analgesic, antipyretic and anti-inflammatory effects of indomethacin as well as adverse reactions associated with the drug occur as a result of decreased prostaglandin synthesis. Its antipyretic effects may be due to action on the hypothalamus, resulting in increased peripheral blood flow, vasodilation, and subsequent heat dissipation. The exact mechanism of action of indometacin in inducing closure of a patent ductus arteriosus is not fully understood; however, it is thought to be through inhibition of prostaglandin synthesis. At birth, the ductus arteriosus is normally closed as the tension of the oxygen increases significantly after birth. Patent ductus arteriosus in premature infants is associated with congenital heart malformations where PGE1 mediates an opposite effect to that of oxygen. PGE1 dilates the ductus arteriosus through smooth muscle relaxation and prevents the closure of the ductus arteriosus. By inhibiting the synthesis of prostaglandins, indometacin promotes the closure of ductus arteriosus. Indometacin has been described as possessing anticancer and antiviral properties through activation of protein kinase R (PKR) and downstream phosphorylation of eIF2, inhibiting protein synthesis.

    The anti-inflammatory, analgesic, and antipyretic effects of indomethacin and other nonsteroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2) (e.g., celecoxib), appear to result from inhibition of prostaglandin synthesis. While the precise mechanism of the anti-inflammatory and analgesic effects of NSAIAs continues to be investigated, these effects appear to be mediated principally through inhibition of the COX-2 isoenzyme at sites of inflammation with subsequent reduction in the synthesis of certain prostaglandins from their arachidonic acid precursors. This effect may be related to inhibition of the synthesis of prostaglandins that are believed to play a role in modulating the rate and extent of leukocyte infiltration during inflammation. Indomethacin also inhibits lysosomal enzyme release from polymorphonuclear leukocytes. Although the mechanism has not been determined, this effect appears to depend on the nature of the stimulus and may not be related to inhibition of prostaglandin synthesis. It has also been postulated that indomethacin, as an inhibitor of phosphodiesterase, may increase intracellular concentrations of cyclic adenosine monophosphate (AMP) which may play a role in the inflammatory response. In supratherapeutic concentrations, indomethacin depresses the synthesis of mucopolysaccharides through uncoupling of oxidative phosphorylation. By inhibiting cyclooxygenase, indomethacin and some other NSAIAs may also interfere with prostaglandin-mediated formation of autoantibodies that are involved in the inflammatory process.

    American Society of Health-System Pharmacists 2015; Drug Information 2015. Bethesda, MD. 2015, p. 2085

    This article reviews the pathogenic mechanism of non-steroidal anti-inflammatory drug (NSAID)-induced gastric damage, focusing on the relation between cyclooxygenase (COX) inhibition and various functional events. NSAIDs, such as indomethacin, at a dose that inhibits prostaglandin (PG) production, enhance gastric motility, resulting in an increase in mucosal permeability, neutrophil infiltration and oxyradical production, and eventually producing gastric lesions. These lesions are prevented by pretreatment with PGE2 and antisecretory drugs, and also via an atropine-sensitive mechanism, not related to antisecretory action. Although neither rofecoxib (a selective COX-2 inhibitor) nor SC-560 (a selective COX-1 inhibitor) alone damages the stomach, the combined administration of these drugs provokes gastric lesions. SC-560, but not rofecoxib, decreases prostaglandin E2 (PGE2) production and causes gastric hypermotility and an increase in mucosal permeability. COX-2 mRNA is expressed in the stomach after administration of indomethacin and SC-560 but not rofecoxib. The up-regulation of indomethacin-induced COX-2 expression is prevented by atropine at a dose that inhibits gastric hypermotility. In addition, selective COX-2 inhibitors have deleterious influences on the stomach when COX-2 is overexpressed under various conditions, including adrenalectomy, arthritis, and Helicobacter pylori-infection. In summary, gastric hypermotility plays a primary role in the pathogenesis of NSAID-induced gastric damage, and the response, causally related with PG deficiency due to COX-1 inhibition, occurs prior to other pathogenic events such as increased mucosal permeability; and the ulcerogenic properties of NSAIDs require the inhibition of both COX-1 and COX-2, the inhibition of COX-1 upregulates COX-2 expression in association with gastric hypermotility, and PGs produced by COX-2 counteract the deleterious effect of COX-1 inhibition.

    PMID:22611307 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3351764 Takeuchi K; World J Gastroenterol 18 (18): 2147-60 (2012)

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FABBRICA ITALIANA SINTETICI","supplierCountry":"ITALY","foreign_port":"MILAN","customer":"GLENMARK PHARMACEUTICALS","customerCountry":"INDIA","quantity":"173.50","actualQuantity":"173.5","unit":"KGS","unitRateFc":"180","totalValueFC":"34633.1","currency":"EUR","unitRateINR":"16686","date":"30-Jul-2024","totalValueINR":"2895021","totalValueInUsd":"34633.1","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"4779197","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN","supplierAddress":"VIALE MILANO,2636075 MONTECCHIO MAGGIORE(VI)SDNF ITALY","customerAddress":"B\/2 MAHALAXMI CHAMBERS"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729794600,"product":"INDOMETHACIN USP","address":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H","city":"AHMEDABAD,GUJARAT","supplier":"ADVENTA PHARMA DWC-LLC","supplierCountry":"ITALY","foreign_port":"MILAN - MALPENSA","customer":"ZYDUS LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"15.00","actualQuantity":"15","unit":"KGS","unitRateFc":"50000","totalValueFC":"758242.5","currency":"USD","unitRateINR":"4247500","date":"25-Oct-2024","totalValueINR":"63712500","totalValueInUsd":"758242.5","indian_port":"Bombay Air","hs_no":"29339990","bill_no":"6328492","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"MILAN - MALPENSA","supplierAddress":"1802 TRIDENT BAYSIDE, DUBAI MARINA, DUBAI UAE Dubai, , United Arab Emi rates United Arab Emirates","customerAddress":"ZYDUS TOWER, SARKHEJ-GANDHINAGAR,H"}]
    02-Jan-2021
    25-Oct-2024
    KGS
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

    API Imports and Exports

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

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - SUSPENSION;ORAL - 25MG/5ML

    USFDA APPLICATION NUMBER - 18332

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    DOSAGE - CAPSULE;ORAL - 20MG

    USFDA APPLICATION NUMBER - 204768

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    DOSAGE - CAPSULE;ORAL - 40MG

    USFDA APPLICATION NUMBER - 204768

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