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    Chemistry

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    Also known as: 1197-18-8, Trans-4-(aminomethyl)cyclohexanecarboxylic acid, Cyklokapron, 4-(aminomethyl)cyclohexanecarboxylic acid, Trans amcha, Tranexamsaeure
    Molecular Formula
    C8H15NO2
    Molecular Weight
    157.21  g/mol
    InChI Key
    GYDJEQRTZSCIOI-UHFFFAOYSA-N
    FDA UNII
    37YD696II6
    Tranexamic Acid
    Antifibrinolytic hemostatic used in severe hemorrhage.
    Tranexamic acid is an Antifibrinolytic Agent. The physiologic effect of tranexamic acid is by means of Decreased Fibrinolysis.
    1 2D Structure

    Tranexamic Acid

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-(aminomethyl)cyclohexane-1-carboxylic acid
    2.1.2 InChI
    InChI=1S/C8H15NO2/c9-5-6-1-3-7(4-2-6)8(10)11/h6-7H,1-5,9H2,(H,10,11)
    2.1.3 InChI Key
    GYDJEQRTZSCIOI-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CC(CCC1CN)C(=O)O
    2.2 Other Identifiers
    2.2.1 UNII
    37YD696II6
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Amca

    2. Amcha

    3. Amchafibrin

    4. Anvitoff

    5. Cyklokapron

    6. Exacyl

    7. Kabi 2161

    8. Spotof

    9. T-amcha

    10. Trans-4-(aminomethyl)cyclohexanecarboxylic Acid

    11. Transamin

    12. Ugurol

    2.3.2 Depositor-Supplied Synonyms

    1. 1197-18-8

    2. Trans-4-(aminomethyl)cyclohexanecarboxylic Acid

    3. Cyklokapron

    4. 4-(aminomethyl)cyclohexanecarboxylic Acid

    5. Trans Amcha

    6. Tranexamsaeure

    7. Transamin

    8. 701-54-2

    9. Tranhexamic Acid

    10. Cyclocapron

    11. Amstat

    12. Trans-amcha

    13. 1197-17-7

    14. Rikavarin

    15. Tamcha

    16. Amikapron

    17. Anvitoff

    18. Ugurol

    19. Amcha

    20. Frenolyse

    21. Trasamlon

    22. Carxamin

    23. Emorhalt

    24. Tranexan

    25. Mastop

    26. Rikavarin-s

    27. Amca

    28. Cis-4-(aminomethyl)cyclohexanecarboxylic Acid

    29. Exacyl

    30. Tranexmic Acid

    31. Hexapromin

    32. Transamlon

    33. Hexatron

    34. Spiramin

    35. Tranex

    36. Cis-amcha

    37. Cis-tranexamic Acid

    38. Trans-4-aminomethylcyclohexane-1-carboxylic Acid

    39. 4-(aminomethyl)cyclohexane-1-carboxylic Acid

    40. Trans-tranexamic Acid

    41. Acidum Tranexamicum

    42. Cyclohexanecarboxylic Acid, 4-(aminomethyl)-, Trans-

    43. Lysteda

    44. Acido Tranexamico

    45. Cl 65336

    46. Acide Tranexamique

    47. Femstrual

    48. Bay 3517

    49. Cyclo-f

    50. Rp 18,429

    51. Cyclohexanecarboxylic Acid, 4-(aminomethyl)-

    52. 4-(aminomethyl)-cyclohexanecarboxylic Acid

    53. Cyclohexanecarboxylic Acid, 4-(aminomethyl)-, Cis-

    54. Cyclokapron

    55. Espercil

    56. Haematrix

    57. (1r,4r)-4-(aminomethyl)cyclohexane-1-carboxylic Acid

    58. Cis-4-aminomethylcyclohexane-1-carboxylic Acid

    59. Trans-p-(aminomethyl)cyclohexanecarboxylic Acid

    60. Cl-65336

    61. Dv 79

    62. Dv79

    63. Trans-4-(aminomethyl)-1-cyclohexanecarboxylic Acid

    64. Lb1148

    65. Mfcd00001466

    66. Cis-4-(aminomethyl)cyclohexane-1-carboxylic Acid

    67. Nsc-291305

    68. Trans-1-(aminomethyl)cyclohexane-4-carboxylic Acid

    69. Trans-4-(aminomethyl)cyclohexane-1-carboxylic Acid

    70. Tranexamic Acid (transamin)

    71. Retavase

    72. Chebi:48669

    73. 37yd696ii6

    74. 6t84r30kc1

    75. Nsc291305

    76. Trans-4-(aminomethyl)cyclohexanecarboxylic Acid Ester

    77. 4-aminomethylcyclohexanecarboxylic Acid

    78. Ncgc00016569-01

    79. Rp-18429

    80. Cas-1197-18-8

    81. 4-(aminomethyl)cyclohexanecarboxylic Acid (trans-)

    82. Amh

    83. Tranexamic Acid Cis-form

    84. Acide Tranexamique [inn-french]

    85. Acido Tranexamico [inn-spanish]

    86. Acidum Tranexamicum [inn-latin]

    87. Dv-79

    88. Cyklokapron (tn)

    89. Rikavarin (tn)

    90. Transamin (tn)

    91. Haku

    92. Sr-05000001794

    93. Einecs 214-818-2

    94. Trans-1-aminomethylcyclohexane-4-carboxylic Acid

    95. Nsc 291305

    96. Brn 2207452

    97. Tranexamate

    98. Tranexamic-acid

    99. Unii-37yd696ii6

    100. Unii-6t84r30kc1

    101. 1ceb

    102. Prestwick_476

    103. Albb-006013

    104. Tranexamic Acid,(s)

    105. Spectrum_001391

    106. Tranexamic Acid [usan:usp:inn:ban:jan]

    107. Prestwick0_000171

    108. Prestwick1_000171

    109. Prestwick2_000171

    110. Prestwick3_000171

    111. Spectrum2_000655

    112. Spectrum3_001189

    113. Spectrum4_000046

    114. Spectrum5_001258

    115. Chembl877

    116. Trans-4-(aminomethyl)cyclohexane-carboxylic Acid

    117. Dsstox_cid_25350

    118. Dsstox_rid_80817

    119. Dsstox_gsid_45350

    120. Oprea1_786414

    121. Schembl16974

    122. Bspbio_000061

    123. Bspbio_002837

    124. Kbiogr_000511

    125. Kbioss_001871

    126. Tranexamic Acid [mi]

    127. 3-14-00-00868 (beilstein Handbook Reference)

    128. Cis-4-(aminomethyl)cyclohexanecarboxylicacid

    129. Divk1c_000655

    130. Schembl186034

    131. Schembl349408

    132. Spectrum1502026

    133. Tranexamic Acid [inn]

    134. Tranexamic Acid [jan]

    135. Tranexamic Acid, Cis-

    136. Spbio_000689

    137. Spbio_001982

    138. Tranexamic Acid [inci]

    139. Tranexamic Acid [usan]

    140. Bpbio1_000069

    141. Chembl292500

    142. Gtpl6573

    143. Schembl6885575

    144. Schembl9885628

    145. Tranexamic Acid [vandf]

    146. Dtxsid3045350

    147. Tranexamic Acid [mart.]

    148. Chebi:94518

    149. Hms502a17

    150. Kbio1_000655

    151. Kbio2_001871

    152. Kbio2_004439

    153. Kbio2_007007

    154. Kbio3_002337

    155. Dtxsid50904827

    156. Tranexamic Acid [usp-rs]

    157. Tranexamic Acid [who-dd]

    158. Wln: L6tj Avq D1z -t

    159. Ninds_000655

    160. Hms1568d03

    161. Hms1921f08

    162. Hms2092p03

    163. Hms2095d03

    164. Hms3712d03

    165. Hms3744g07

    166. Pharmakon1600-01502026

    167. Bcp13133

    168. Bcp18146

    169. Hy-b0149

    170. Tranexamic Acid (jp17/usp/inn)

    171. Zinc1542907

    172. Tox21_110500

    173. Bbl004469

    174. Bdbm50428067

    175. Ccg-39692

    176. Mfcd00064951

    177. Mfcd19706018

    178. Nsc758176

    179. S1875

    180. Stk503668

    181. Tranexamic Acid [orange Book]

    182. Tranexamic Acid(random Configuration)

    183. Akos005171632

    184. Akos015854573

    185. Akos024257901

    186. Tranexamic Acid [ep Monograph]

    187. Tranexamic Acid [usp Impurity]

    188. Tranexamic Acid Cis-form [mi]

    189. Zinc100007011

    190. Zinc100071256

    191. Ab86495

    192. Ac-4687

    193. Am84352

    194. Bs-3867

    195. Cs-1965

    196. Db00302

    197. Nsc-758176

    198. Tranexamic Acid [usp Monograph]

    199. 4-(aminomethyl)cyclohexanecarboxylicacid

    200. 4-aminomethyl-cyclohexanecarboxylic Acid

    201. Idi1_000655

    202. Ncgc00016569-02

    203. Ncgc00016569-03

    204. Ncgc00016569-04

    205. Ncgc00016569-05

    206. Ncgc00016569-06

    207. Ncgc00016569-08

    208. Ncgc00016569-09

    209. Ncgc00094944-01

    210. Ncgc00094944-02

    211. P-(aminomethyl)cyclohexanecarboxylic Acid

    212. As-80121

    213. Bp-12345

    214. Sy011438

    215. Tranexamic Acid Related Compound B

    216. Ts-02090

    217. Sbi-0051705.p002

    218. Trans 4aminomethylcyclohexanecarboxylic Acid

    219. Db-074265

    220. Tranexamic Acid 100 Microg/ml In Methanol

    221. Trans-4-aminomethylcyclohexylcarboxylic Acid

    222. Trans-p-aminomethylcyclohexanecarboxylic Acid

    223. A0236

    224. Ab00052260

    225. Bb 0260034

    226. Cs-0013687

    227. Cs-0055045

    228. Ft-0654339

    229. Ft-0675360

    230. Ft-0700806

    231. Trans 4-aminomethylcyclohexanecarboxylic Acid

    232. Trans-4-aminomethylcyclohexanecarboxylic Acid

    233. En300-91506

    234. Trans-4(aminomethyl)cyclohexanecarboxylic Acid

    235. Trans-4-(aminomethyl)cyclohexylcarboxylic Acid

    236. Trans-4-aminomethyl Cyclohexanecarboxylic Acid

    237. Trans-4-aminomethyl-cyclohexanecarboxylic Acid

    238. Trans-4-aminomethylcyclohexane Carboxylic Acid

    239. D01136

    240. P15619

    241. P20836

    242. T71247

    243. Trans-4-aminomethyl Cyclohexane Carboxylic Acid

    244. Trans4-aminomethylcyclohexane-1-carboxylic Acid

    245. Ab00052260-04

    246. Ab00052260_05

    247. Ab00052260_06

    248. Tranexamic Acid Impurity B [ep Impurity]

    249. Trans-4 -(aminomethyl)cyclohexanecarboxylic Acid

    250. Trans-4-(aminomethyl)-cyclohexanecarboxylic Acid

    251. Trans-4-(aminomethyl)cyclohexane Carboxylic Acid

    252. Trans-4-aminomethyl-1-cyclohexanecarboxylic Acid

    253. (1r,4r)-4-(aminomethyl)cyclohexanecarboxylic Acid

    254. (trans)-4-(aminomethyl)cyclohexanecarboxylic Acid

    255. 197t188

    256. 4-trans-(aminomethyl)cyclohexanecarboxylic Acid #

    257. Q418666

    258. Trans-?4-?(aminomethyl)?cyclohexanecarboxylic Acid

    259. Trans-4- (aminomethyl) Cyclohexanecarboxylic Acid

    260. Trans-4-(aminomethyl)- Cyclohexane Carboxylic Acid

    261. Trans-4-(aminomethyl)-cyclohexane Carboxylic Acid

    262. Trans-4-aminomethyl-1-cyclohexane Carboxylic Acid

    263. 4alpha-aminomethyl-1alpha-cyclohexanecarboxylic Acid

    264. Q-201848

    265. Sr-05000001794-1

    266. Sr-05000001794-2

    267. Sr-05000001794-3

    268. Tranexamic Acid 100 Microg/ml In Acetonitrile:water

    269. Brd-k15014948-001-01-2

    270. Q27256710

    271. Trans-4-(aminomethyl)cyclohexanecarboxylic Acid, 97%

    272. 4-(aminomethyl)cyclohexanecarboxylic Acid;tranexamic Acid

    273. F8886-7867

    274. Tranexamic Acid Related Compound B [usp Impurity]

    275. Z1741970429

    276. Rel-(1r,4r)-4-(aminomethyl)cyclohexane-1-carboxylic Acid

    277. Tranexamic Acid, European Pharmacopoeia (ep) Reference Standard

    278. 4-(aminomethyl)cyclohexanecarboxylic Acid (cis- And Trans- Mixture)

    279. Tranexamic Acid, United States Pharmacopeia (usp) Reference Standard

    280. 4-(aminomethyl)cyclohexanecarboxylic Acid (cis- And Trans- Mixture);

    281. Tranexamic Acid, Pharmaceutical Secondary Standard; Certified Reference Material

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 157.21 g/mol
    Molecular Formula C8H15NO2
    XLogP3-2
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count2
    Exact Mass157.110278721 g/mol
    Monoisotopic Mass157.110278721 g/mol
    Topological Polar Surface Area63.3 Ų
    Heavy Atom Count11
    Formal Charge0
    Complexity139
    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 6  
    Drug NameCyklokapron
    PubMed HealthTranexamic Acid
    Drug ClassesHemostatic
    Drug LabelEach mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL....
    Active IngredientTranexamic acid
    Dosage FormInjectable
    RouteInjection
    Strength100mg/ml
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    2 of 6  
    Drug NameLysteda
    PubMed HealthTranexamic Acid
    Drug ClassesHemostatic
    Drug LabelLYSTEDA is an antifibrinolytic drug. The chemical name is trans-4-aminomethyl-cyclohexanecarboxylic acid. The structural formula is:Tranexamic acid is a white crystalline...
    Active IngredientTranexamic acid
    Dosage FormTablet
    RouteOral
    Strength650mg
    Market StatusPrescription
    CompanyFerring Pharms As

    3 of 6  
    Drug NameTranexamic acid
    PubMed HealthTranexamic Acid
    Drug ClassesHemostatic
    Drug LabelTranexamic Acid Tablets is an antifibrinolytic drug. The chemical name is trans-4-aminomethyl-cyclohexanecarboxylic acid. The structural formula is:Tranexamic acid is a white crystalline powder. It is freely soluble in water and in glacial acetic aci...
    Active IngredientTranexamic acid
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength650mg; 650 mg; 100mg/ml
    Market StatusPrescription
    CompanyActavis Labs Fl; Apotex; Acic Fine Chems; Emcure Pharms; Fresenius Kabi Usa; Versapharm; Mylan Institutional; X-gen Pharms; Luitpold

    4 of 6  
    Drug NameCyklokapron
    PubMed HealthTranexamic Acid
    Drug ClassesHemostatic
    Drug LabelEach mL of the sterile solution for intravenous injection contains 100 mg tranexamic acid and Water for Injection to 1 mL....
    Active IngredientTranexamic acid
    Dosage FormInjectable
    RouteInjection
    Strength100mg/ml
    Market StatusPrescription
    CompanyPharmacia And Upjohn

    5 of 6  
    Drug NameLysteda
    PubMed HealthTranexamic Acid
    Drug ClassesHemostatic
    Drug LabelLYSTEDA is an antifibrinolytic drug. The chemical name is trans-4-aminomethyl-cyclohexanecarboxylic acid. The structural formula is:Tranexamic acid is a white crystalline...
    Active IngredientTranexamic acid
    Dosage FormTablet
    RouteOral
    Strength650mg
    Market StatusPrescription
    CompanyFerring Pharms As

    6 of 6  
    Drug NameTranexamic acid
    PubMed HealthTranexamic Acid
    Drug ClassesHemostatic
    Drug LabelTranexamic Acid Tablets is an antifibrinolytic drug. The chemical name is trans-4-aminomethyl-cyclohexanecarboxylic acid. The structural formula is:Tranexamic acid is a white crystalline powder. It is freely soluble in water and in glacial acetic aci...
    Active IngredientTranexamic acid
    Dosage FormTablet; Injectable
    RouteInjection; Oral
    Strength650mg; 650 mg; 100mg/ml
    Market StatusPrescription
    CompanyActavis Labs Fl; Apotex; Acic Fine Chems; Emcure Pharms; Fresenius Kabi Usa; Versapharm; Mylan Institutional; X-gen Pharms; Luitpold

    4.2 Drug Indication

    Taken orally, tranexamic acid is indicated for the treatment of hereditary angioedema, cyclic heavy menstrual bleeding in premenopausal females, and other instances of significant bleeding in the context of hyperfibrinolysis. Given intravenously, tranexamic acid is indicated for short-term use (2-8 days) in patients with hemophilia to prevent or reduce bleeding following tooth extraction.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Tranexamic acid is an antifibrinolytic that competitively inhibits the activation of plasminogen to plasmin. At much higher concentrations it behaves as a noncompetitive inhibitor of plasmin similar to [aminocaproic acid], a similar antifibrinolytic which is 10-fold less potent. Tranexamic acid binds more strongly than aminocaproic acid to both the strong and weak receptor sites of the plasminogen molecule in a ratio corresponding to the difference in potency between the compounds. In patients with hereditary angioedema, inhibition of the formation and activity of plasmin by tranexamic acid may prevent attacks of angioedema by decreasing plasmin-induced activation of the first complement protein (C1). Off-target antagonism of GABA(A) receptors may be associated with the development of convulsions and hyperexcitability following tranexamic acid administration - the risk appears higher with improper administration or administration during cardiovascular surgery. Consider EEG monitoring of patients with a history of seizure.

    5.2 MeSH Pharmacological Classification

    Antifibrinolytic Agents

    Agents that prevent fibrinolysis or lysis of a blood clot or thrombus. Several endogenous antiplasmins are known. The drugs are used to control massive hemorrhage and in other coagulation disorders. (See all compounds classified as Antifibrinolytic Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    TRANEXAMIC ACID
    5.3.2 FDA UNII
    6T84R30KC1
    5.3.3 Pharmacological Classes
    Decreased Fibrinolysis [PE]; Antifibrinolytic Agent [EPC]
    5.4 ATC Code

    B02AA02

    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

    B - Blood and blood forming organs

    B02 - Antihemorrhagics

    B02A - Antifibrinolytics

    B02AA - Amino acids

    B02AA02 - Tranexamic acid

    5.5 Absorption, Distribution and Excretion

    Absorption

    The bioavailability of tranexamic acid after oral administration in humans is approximately 30 to 50% of the ingested dose and is not affected by food intake. The Cmax and Tmax following multiple oral doses (1300 mg three times daily x 5 days) were 16.41 mcg/mL and 2.5 h, respectively.

    Route of Elimination

    Urinary excretion is the primary means of tranexamic acid elimination, with >95% of an administered dose excreted in the urine as unchanged parent drug. The rate of excretion is dependent on the route of administration - approximately 90% of an intravenously administered dose is excreted within 24 hours whereas only 39% of an orally administered dose is excreted within the same time frame.

    Volume of Distribution

    The initial volume of distribution of tranexamic acid is 0.18 L/kg and its steady-state volume of distribution is 0.39 L/kg. Tranexamic acid distributes into cerebrospinal fluid and the aqueous humor of the eye at concentrations approximately 1/10th of typical plasma concentrations. Tranexamic acid is also able to cross the placenta, found in cord blood at concentrations equivalent to maternal plasma concentrations.

    Clearance

    The plasma clearance of tranexamic acid is 110-116 mL/min.

    5.6 Metabolism/Metabolites

    Tranexamic acid metabolism is poorly characterized but does not appear to be a significant means of drug elimination. According to prescribing information, approximately 1% and 0.5% of an orally administered dose are excreted as a dicarboxylic acid and acetylated metabolite, respectively.

    5.7 Biological Half-Life

    Following intravenous administration, the apparent elimination half-life is approximately 2 hours and the mean terminal half-life is approximately 11 hours.

    5.8 Mechanism of Action

    Tranexamic acid competitively and reversibly inhibits the activation of plasminogen via binding at several distinct sites, including four or five low-affinity sites and one high-affinity site, the latter of which is involved in its binding to fibrin. The binding of plasminogen to fibrin induces fibrinolysis - by occupying the necessary binding sites tranexamic acid prevents this dissolution of fibrin, thereby stabilizing the clot and preventing hemorrhage.

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    Metrochem API Private Limited

    India

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    Virtual BoothIKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.

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    India

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    Virtual BoothMalladi is a leader in Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl // USFDA, EDQM, ANSM, KFDA, and TGA inspected.

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    Certificate Number : CEP 2022-243 - Rev 00

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    Ami Lifesciences Private Limited

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    Certificate Number : R0-CEP 2019-250 - Rev 02

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    Registrant Name : Aging Life Science Co., Ltd.

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    Registration Number : 20241023-210-J-1706

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    HRV Global Life Sciences

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    Shilpa Medicare

    India

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    Shilpa Medicare

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    DMF Review : Reviewed

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    DMF Number : 33086

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    Certificate Number : CEP 2018-048 - Rev 02

    Issue Date : 2024-10-21

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    Substance Number : 875

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    Registrant Name : Palm East Co., Ltd.

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    Ami Lifesciences Private Limited

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    Tranexamic acid

    Registrant Name : Aging Life Science Co., Ltd.

    Registration Date : 2024-10-23

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    Manufacturer Name : Ami Lifesciences Private Lim...

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    Shilpa Medicare

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    Tranexamic acid

    Registrant Name : Sangjin Corporation

    Registration Date : 2021-03-25

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    Tranexamic acid

    Registrant Name : Palm East Co., Ltd.

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OF","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRAS AIR","supplierAddress":"PLOT NO.10, SHOP NO.80,RAJENDRA GUNJ ,, RAICHUR , KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"TRANEXAMIC ACID","year":"2021","qtr":"Q1","strtotime":1615401000,"product":"TRANEXAMIC ACID","address":"PLOT NO.10, SHOP NO.80,RAJENDRA GUNJ ,","city":"RAICHUR , KARNATAKA","supplier":"SHILPA MEDICARE","supplierCountry":"INDIA","foreign_port":"MONTREAL-DORAVAL APT","customer":"GALENOVA INC","customerCountry":"CANADA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"168.4","totalValueFC":"4166.7","currency":"USD","unitRateINR":12133.6,"date":"11-Mar-2021","totalValueINR":"303340","totalValueInUsd":"4166.7","indian_port":"HYDERABAD AIR","hs_no":"29224990","bill_no":"9272131","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"PLOT NO.10, SHOP NO.80,RAJENDRA GUNJ ,, RAICHUR , KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"TRANEXAMIC ACID","year":"2021","qtr":"Q1","strtotime":1615746600,"product":"TRANEXAMIC ACID","address":"NO.9, G.S.T. 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THOMAS MOUNT, CHENNAI, TAMIL NADU","customerAddress":""},{"dataSource":"API Export","activeIngredients":"TRANEXAMIC ACID","year":"2021","qtr":"Q1","strtotime":1616524200,"product":"TRANEXAMIC ACID","address":"PLOT NO.10, SHOP NO.80,RAJENDRA GUNJ ,","city":"RAICHUR , KARNATAKA","supplier":"SHILPA MEDICARE","supplierCountry":"INDIA","foreign_port":"SEOUL - INCHEON INT\\'","customer":"DAI HAN PHARM ","customerCountry":"KOREA, REPUBLIC OF","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"116.6","totalValueFC":"115376.2","currency":"USD","unitRateINR":8399.5499999999993,"date":"24-Mar-2021","totalValueINR":"8399550","totalValueInUsd":"115376.2","indian_port":"HYDERABAD AIR","hs_no":"29224990","bill_no":"9617772","productDescription":"API","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"PLOT NO.10, SHOP NO.80,RAJENDRA GUNJ ,, RAICHUR , KARNATAKA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"TRANEXAMIC ACID","year":"2021","qtr":"Q1","strtotime":1616956200,"product":"TRANEXAMIC ACID","address":"PLOT NO.10, SHOP NO.80,RAJENDRA GUNJ ,","city":"RAICHUR , KARNATAKA","supplier":"SHILPA MEDICARE","supplierCountry":"INDIA","foreign_port":"CINCINNATI OH","customer":"TO ORDER","customerCountry":"UNITED STATES","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"140.6","totalValueFC":"20873.8","currency":"USD","unitRateINR":10130.959999999999,"date":"29-Mar-2021","totalValueINR":"1519644","totalValueInUsd":"20873.8","indian_port":"HYDERABAD AIR","hs_no":"29224990","bill_no":"9731362","productDescription":"API","marketType":"REGULATED MARKET","country":"UNITED STATES","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD AIR","supplierAddress":"PLOT NO.10, SHOP NO.80,RAJENDRA GUNJ ,, RAICHUR , KARNATAKA","customerAddress":""},{"dataSource":"API 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    01-Jan-2021
    29-Nov-2024
    KGS
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    Average Price (USD/KGS)

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    Total Quantity (KGS)

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

    API Imports and Exports

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    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - INJECTABLE;INJECTION - 100MG/ML

    USFDA APPLICATION NUMBER - 19281

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    DOSAGE - TABLET;ORAL - 650MG

    USFDA APPLICATION NUMBER - 22430

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    ABOUT THIS PAGE

    Tranexamic Acid Manufacturers

    A Tranexamic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tranexamic Acid, including repackagers and relabelers. The FDA regulates Tranexamic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tranexamic Acid API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Tranexamic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Tranexamic Acid Suppliers

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

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

    Tranexamic Acid USDMF

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

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

    click here to find a list of Tranexamic Acid suppliers with USDMF on PharmaCompass.

    Tranexamic Acid JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Tranexamic Acid Drug Master File in Japan (Tranexamic Acid JDMF) empowers Tranexamic Acid API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Tranexamic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Tranexamic Acid JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Tranexamic Acid suppliers with JDMF on PharmaCompass.

    Tranexamic Acid KDMF

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

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

    After submitting a Tranexamic Acid KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Tranexamic Acid API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Tranexamic Acid suppliers with KDMF on PharmaCompass.

    Tranexamic Acid CEP

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

    A Tranexamic Acid CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tranexamic Acid CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of Tranexamic Acid suppliers with CEP (COS) on PharmaCompass.

    Tranexamic Acid WC

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

    click here to find a list of Tranexamic Acid suppliers with Written Confirmation (WC) on PharmaCompass.

    Tranexamic Acid NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Tranexamic Acid as an active pharmaceutical ingredient (API).

    Finished drug products

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

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Tranexamic Acid as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Tranexamic Acid and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tranexamic Acid NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Tranexamic Acid suppliers with NDC on PharmaCompass.

    Tranexamic Acid GMP

    Tranexamic Acid Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Tranexamic Acid GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Tranexamic Acid GMP manufacturer or Tranexamic Acid GMP API supplier for your needs.

    Tranexamic Acid CoA

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

    Tranexamic Acid CoA mostly includes findings from lab analyses of a specific batch. For each Tranexamic Acid CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Tranexamic Acid may be tested according to a variety of international standards, such as European Pharmacopoeia (Tranexamic Acid EP), Tranexamic Acid JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tranexamic Acid USP).

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