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    Chemistry

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    Also known as: 19387-91-8, Tindamax, Trimonase, Fasigyn, Tricolam, Fasigin
    Molecular Formula
    C8H13N3O4S
    Molecular Weight
    247.27  g/mol
    InChI Key
    HJLSLZFTEKNLFI-UHFFFAOYSA-N
    FDA UNII
    033KF7V46H
    Tinidazole
    A nitroimidazole alkylating agent that is used as an antitrichomonal agent against TRICHOMONAS VAGINALIS; ENTAMOEBA HISTOLYTICA; and GIARDIA LAMBLIA infections. It also acts as an antibacterial agent for the treatment of BACTERIAL VAGINOSIS and anaerobic bacterial infections.
    Tinidazole is a Nitroimidazole Antimicrobial.
    1 2D Structure

    Tinidazole

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    1-(2-ethylsulfonylethyl)-2-methyl-5-nitroimidazole
    2.1.2 InChI
    InChI=1S/C8H13N3O4S/c1-3-16(14,15)5-4-10-7(2)9-6-8(10)11(12)13/h6H,3-5H2,1-2H3
    2.1.3 InChI Key
    HJLSLZFTEKNLFI-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CCS(=O)(=O)CCN1C(=NC=C1[N+](=O)[O-])C
    2.2 Other Identifiers
    2.2.1 UNII
    033KF7V46H
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Bioshik

    2. Cp 12,574

    3. Cp 12574

    4. Cp-12,574

    5. Cp-12574

    6. Cp12,574

    7. Cp12574

    8. Fasigin

    9. Fasigyn

    10. Fasigyne

    11. Fasygin

    12. Simplotan

    13. Tricolam

    2.3.2 Depositor-Supplied Synonyms

    1. 19387-91-8

    2. Tindamax

    3. Trimonase

    4. Fasigyn

    5. Tricolam

    6. Fasigin

    7. 1-(2-(ethylsulfonyl)ethyl)-2-methyl-5-nitro-1h-imidazole

    8. Simplotan

    9. 1-(2-ethylsulfonylethyl)-2-methyl-5-nitroimidazole

    10. 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitro-1h-imidazole

    11. Timidazole

    12. Haisigyn

    13. Cp-12574

    14. 1h-imidazole, 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitro-

    15. Cp-12,574

    16. 1-(2-(ethylsulfonyl)ethyl)-2-methyl-5-nitroimidazole

    17. 1-[2-(ethanesulfonyl)ethyl]-2-methyl-5-nitro-1h-imidazole

    18. Tinidazol

    19. Chebi:63627

    20. 1h-imidazole, 1-(2-(ethylsulfonyl)ethyl)-2-methyl-5-nitro-

    21. Nsc-758189

    22. Mls000069717

    23. 148159-84-6

    24. Bioshik

    25. 033kf7v46h

    26. 1-(2-ethylsulfonylethyl)-2-methyl-5-nitro-imidazole

    27. Ncgc00016741-01

    28. Tinidazolum

    29. Smr000058194

    30. Sorquetan

    31. Pletil

    32. Tinidazole 100 Microg/ml In Acetonitrile

    33. Cas-19387-91-8

    34. Dsstox_cid_3676

    35. Dsstox_rid_77141

    36. Dsstox_gsid_23676

    37. 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole

    38. Glongyn

    39. Amtiba

    40. Cp 12574

    41. Tinidazol [inn-spanish]

    42. Tinidazolum [inn-latin]

    43. 1h-imidazole, 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitro-, Radical Ion(1-)

    44. Ccris 7621

    45. Hsdb 7362

    46. Sr-01000000210

    47. Einecs 243-014-4

    48. Brn 0618182

    49. Symplotan

    50. Ethyl (2-(2-methyl-5-nitro-1-imidazolyl)ethyl)sulfone

    51. Unii-033kf7v46h

    52. Fasigyntrade Mark

    53. Tindamaxtrade Mark

    54. Tinidazole,(s)

    55. Simplotantrade Mark

    56. Haisigyn (tn)

    57. Tindamax (tn)

    58. Prestwick_136

    59. Cp12574

    60. Tinidazole [usan:usp:inn:ban:jan]

    61. Spectrum_001266

    62. Opera_id_779

    63. Specplus_000708

    64. Tinidazole [mi]

    65. Tinidazole [inn]

    66. Tinidazole [jan]

    67. Prestwick0_000766

    68. Prestwick1_000766

    69. Prestwick2_000766

    70. Prestwick3_000766

    71. Spectrum2_000648

    72. Spectrum3_001512

    73. Spectrum4_000230

    74. Spectrum5_001715

    75. Tinidazole [hsdb]

    76. Tinidazole [usan]

    77. Tinidazole [vandf]

    78. Tinidazole [mart.]

    79. Chembl1220

    80. Tinidazole [usp-rs]

    81. Tinidazole [who-dd]

    82. Oprea1_342844

    83. Schembl21141

    84. Bspbio_000812

    85. Bspbio_003183

    86. Kbiogr_000899

    87. Kbioss_001746

    88. Methyl-5-nitro-1h-imidazole

    89. 5-23-05-00067 (beilstein Handbook Reference)

    90. Mls001146883

    91. Mls001424192

    92. Divk1c_006804

    93. Spectrum1502127

    94. Spbio_000655

    95. Spbio_002751

    96. Bpbio1_000894

    97. Tinidazole (jp17/usp/inn)

    98. 1-(ethylsulfonyl)-2-(2-methyl-5-nitroimidazolyl)ethane

    99. Dtxsid4023676

    100. Tinidazole [orange Book]

    101. Kbio1_001748

    102. Kbio2_001746

    103. Kbio2_004314

    104. Kbio2_006882

    105. Kbio3_002683

    106. Imidazole, 1-(2-(ethylsulfonyl)ethyl)-2-methyl-5-nitro-

    107. Tinidazole [ep Monograph]

    108. 1-(2-(ethylsulfonyl)ethyl)-2-

    109. Hms1570i14

    110. Hms1921l06

    111. Hms2052c09

    112. Hms2090b14

    113. Hms2092d14

    114. Hms2097i14

    115. Hms2231e23

    116. Hms3374p07

    117. Hms3394c09

    118. Hms3652a08

    119. Hms3714i14

    120. Pharmakon1600-01502127

    121. Tinidazole [usp Monograph]

    122. Zinc113446

    123. Bcp20694

    124. Hy-b0177

    125. Tox21 110586

    126. Tox21_110586

    127. Bbl010767

    128. Bdbm50248360

    129. Ccg-39907

    130. Mfcd00057217

    131. Nsc758189

    132. S4068

    133. Stk801761

    134. Akos000747070

    135. Tinidazole 100 Microg/ml In Methanol

    136. Tox21_110586_1

    137. Ac-1618

    138. Cs-2055

    139. Db00911

    140. Ks-5180

    141. Mcule 2580495783

    142. Nc00346

    143. Nsc 758189

    144. Ncgc00016741-02

    145. Ncgc00016741-03

    146. Ncgc00016741-04

    147. Ncgc00016741-05

    148. Ncgc00016741-06

    149. Ncgc00016741-07

    150. Ncgc00016741-09

    151. Ncgc00022212-03

    152. Ncgc00022212-04

    153. Ncgc00022212-05

    154. Sbi-0052674.p002

    155. Ab00053176

    156. Ft-0675241

    157. Sw196447-4

    158. T3058

    159. Vu0239922-6

    160. D01426

    161. Tinidazole, Vetranal(tm), Analytical Standard

    162. Ab00053176-16

    163. Ab00053176_17

    164. Ab00053176_18

    165. A813669

    166. Q1321320

    167. Sr-01000000210-3

    168. Sr-01000000210-5

    169. Sr-01000000210-6

    170. 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazol

    171. Brd-k89125793-001-05-4

    172. Z56763819

    173. 1-(2'-(ethylsulfonyl)-ethyl]-2-methyl-5-nitroimidazole

    174. Tinidazole, European Pharmacopoeia (ep) Reference Standard

    175. Tinidazole, United States Pharmacopeia (usp) Reference Standard

    176. Imidazole, 1-(2-(ethylsulfonyl)ethyl)-2-methyl-4-nitro-

    177. Timtec-bb Sbb006917 Tinidazole 1-(2-(ethylsulfonyl)ethyl)-2-methyl-5-nitro-1h-imidazol

    2.4 Create Date
    2005-03-25
    3 Chemical and Physical Properties
    Molecular Weight 247.27 g/mol
    Molecular Formula C8H13N3O4S
    XLogP3-0.4
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count4
    Exact Mass247.06267708 g/mol
    Monoisotopic Mass247.06267708 g/mol
    Topological Polar Surface Area106 Ų
    Heavy Atom Count16
    Formal Charge0
    Complexity345
    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 NameTindamax
    PubMed HealthTinidazole (By mouth)
    Drug ClassesAmebicide, Extraintestinal, Amebicide, Intestinal, Antibiotic, Antiprotozoal
    Drug LabelTinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure:Tindamax pink oral tablets contain...
    Active IngredientTinidazole
    Dosage FormTablet
    Routeoral; Oral
    Strength250mg; 500mg
    Market StatusPrescription
    CompanyMission Pharma

    2 of 4  
    Drug NameTinidazole
    PubMed HealthTinidazole (By mouth)
    Drug ClassesAmebicide, Extraintestinal, Amebicide, Intestinal, Antibiotic, Antiprotozoal
    Drug LabelTinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure:Tinidazole tablets contain 250 mg o...
    Active IngredientTinidazole
    Dosage FormTablet
    RouteOral
    Strength250mg; 500mg
    Market StatusPrescription
    CompanyUnique Pharm Labs; Novel Labs; Roxane

    3 of 4  
    Drug NameTindamax
    PubMed HealthTinidazole (By mouth)
    Drug ClassesAmebicide, Extraintestinal, Amebicide, Intestinal, Antibiotic, Antiprotozoal
    Drug LabelTinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure:Tindamax pink oral tablets contain...
    Active IngredientTinidazole
    Dosage FormTablet
    Routeoral; Oral
    Strength250mg; 500mg
    Market StatusPrescription
    CompanyMission Pharma

    4 of 4  
    Drug NameTinidazole
    PubMed HealthTinidazole (By mouth)
    Drug ClassesAmebicide, Extraintestinal, Amebicide, Intestinal, Antibiotic, Antiprotozoal
    Drug LabelTinidazole is a synthetic antiprotozoal and antibacterial agent. It is 1-[2-(ethylsulfonyl)ethyl]-2-methyl-5-nitroimidazole, a second-generation 2-methyl-5-nitroimidazole, which has the following chemical structure:Tinidazole tablets contain 250 mg o...
    Active IngredientTinidazole
    Dosage FormTablet
    RouteOral
    Strength250mg; 500mg
    Market StatusPrescription
    CompanyUnique Pharm Labs; Novel Labs; Roxane

    4.2 Therapeutic Uses

    Antitrichomonal Agents

    National Library of Medicine, SIS; ChemIDplus Record for Tinidazole (19387-91-8), MESH heading. Available from, as of March 15, 2006: https://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp

    MEDICATION: Antiprotozoal (Trichomonas, Giardia); antiamebic; antibacterial

    O'Neil, M.J. (ed.). The Merck Index - An Encyclopedia of Chemicals, Drugs, and Biologicals. 13th Edition, Whitehouse Station, NJ: Merck and Co., Inc., 2001., p. 1685

    Oral tinidazole is indicated in the treatment of amebic liver abscess caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. /Included in US product labeling/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2831

    Oral tinidazole is indicated in the treatment of intestinal amebiasis caused by Entamoeba histolytica in both adults and pediatric patients older than three years of age. /Included in US product labeling/

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2831

    For more Therapeutic Uses (Complete) data for TINIDAZOLE (6 total), please visit the HSDB record page.

    4.3 Drug Warning

    Tinidazole is distributed into breast milk at concentrations similar to those in serum. Because tinidazole can be detected in breast milk for up to 72 hours after administration, interruption of breast-feeding during tinidazole therapy and for three days following the last dose is recommended.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2832

    FDA Pregnancy Risk Category: C /RISK CANNOT BE RULED OUT. Adequate, well controlled human studies are lacking, and animal studies have shown risk to the fetus or are lacking as well. There is a chance of fetal harm if the drug is given during pregnancy; but the potential benefits may outweigh the potential risk./

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2832

    Tinidazole crosses the placenta, and enters the fetal circulation. Therefore, it should not be administered to pregnant women during the first trimester.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2832

    Adverse effects occurring in 1% or more of patients receiving tinidazole include GI effects (metallic/bitter taste, nausea, anorexia, dyspepsia/cramps/epigastric discomfort, vomiting, constipation) and nervous system effects (weakness/fatigue/malaise, dizziness, headache).

    McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 875

    For more Drug Warnings (Complete) data for TINIDAZOLE (11 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the treatment of trichomoniasis caused by T. vaginalis in both female and male patients. Also for the treatment of giardiasis caused by G. duodenalis in both adults and pediatric patients older than three years of age and for the treatment of intestinal amebiasis and amebic liver abscess caused by E. histolytica in both adults and pediatric patients older than three years of age.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Tinidazole is a synthetic antiprotozoal agent. Tinidazole demonstrates activity both in vitro and in clinical infections against the following protozoa: Trichomonas vaginalis, Giardia duodenalis (also termed G. lamblia), and Entamoeba histolytica. Tinidazole does not appear to have activity against most strains of vaginal lactobacilli.

    5.2 MeSH Pharmacological Classification

    Antitrichomonal Agents

    Agents used to treat trichomonas infections. (See all compounds classified as Antitrichomonal Agents.)

    Alkylating Agents

    Highly reactive chemicals that introduce alkyl radicals into biologically active molecules and thereby prevent their proper functioning. Many are used as antineoplastic agents, but most are very toxic, with carcinogenic, mutagenic, teratogenic, and immunosuppressant actions. They have also been used as components in poison gases. (See all compounds classified as Alkylating Agents.)

    Anti-Bacterial Agents

    Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    TINIDAZOLE
    5.3.2 FDA UNII
    033KF7V46H
    5.3.3 Pharmacological Classes
    Nitroimidazoles [CS]; Nitroimidazole Antimicrobial [EPC]
    5.4 ATC Code

    J01XD02

    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

    J - Antiinfectives for systemic use

    J01 - Antibacterials for systemic use

    J01X - Other antibacterials

    J01XD - Imidazole derivatives

    J01XD02 - Tinidazole

    P - Antiparasitic products, insecticides and repellents

    P01 - Antiprotozoals

    P01A - Agents against amoebiasis and other protozoal diseases

    P01AB - Nitroimidazole derivatives

    P01AB02 - Tinidazole

    5.5 Absorption, Distribution and Excretion

    Absorption

    Rapidly and completely absorbed under fasting conditions. Administration with food results in a delay in Tmax of approximately 2 hours and a decline in Cmax of approximately 10% and an AUC of 901.6 ± 126.5 mcg hr/mL.

    Route of Elimination

    Tinidazole crosses the placental barrier and is secreted in breast milk. Tinidazole is excreted by the liver and the kidneys. Tinidazole is excreted in the urine mainly as unchanged drug (approximately 20-25% of the administered dose). Approximately 12% of the drug is excreted in the feces.

    Volume of Distribution

    50 L

    Tinidazole is distributed into virtually all tissues and body fluids. Tinidazole also crosses the blood-brain barrier, placental barrier and is distributed into breast milk. Volume of distribution (VolD): about 50 L.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2831

    Under fasted conditions tinidazole is rapidly and completely absorbed. Administration with food resulted in a delay in Tmax of approximately 2 hours and a decline in Cmax of approximately 10% and an AUC of 901.6 + or - 126.5 ug hr/mL.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2831

    Time to peak concentration: 1.6 (+ or - 0.7 hours)

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2831

    Elimination: Renal: 20 to 25% as unchanged drug. Fecal: 12%. In hemodialysis: 43% eliminated during 6 hour hemodialysis session.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2831

    For more Absorption, Distribution and Excretion (Complete) data for TINIDAZOLE (6 total), please visit the HSDB record page.

    5.6 Metabolism/Metabolites

    Hepatic, mainly via CYP3A4. Tinidazole, like metronidazole, is significantly metabolized in humans prior to excretion. Tinidazole is partly metabolized by oxidation, hydroxylation and conjugation. Tinidazole is the major drug-related constituent in plasma after human treatment, along with a small amount of the 2-hydroxymethyl metabolite.

    Tinidazole, like metronidazole, is significantly metabolized in humans prior to excretion. Tinidazole is partly metabolized by oxidation, hydroxylation and conjugation. Tinidazole is the major drug-related constituent in plasma after human treatment, along with a small amount of the 2-hydroxymethyl metabolite. Tinidazole is biotransformed mainly by CYP3A4. In an in vitro metabolic drug interaction study, tinidazole concentrations of up to 75 ug/mL did not inhibit the enzyme activities of CYP1A2, CYP2B6, CYP2C9, CYP2D6, CYP2E1 and CYP3A4.

    Physicians Desk Reference 60th ed, Thomson PDR, Montvale, NJ 2006., p. 2670

    5.7 Biological Half-Life

    The elimination half-life is 13.21.4 hours and the plasma half-life is 12 to 14 hours.

    Elimination: 13.2 (+ or - 1.4) hours. Plasma: approximately 12 to 14 hours.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2831

    5.8 Mechanism of Action

    Tinidazole is a prodrug and antiprotozoal agent. The nitro group of tinidazole is reduced in Trichomonas by a ferredoxin-mediated electron transport system. The free nitro radical generated as a result of this reduction is believed to be responsible for the antiprotozoal activity. It is suggested that the toxic free radicals covalently bind to DNA, causing DNA damage and leading to cell death. The mechanism by which tinidazole exhibits activity against Giardia and Entamoeba species is not known, though it is probably similar.

    The nitro group of tinidazole is reduced by cell extracts of Trichomonas. As a result of this reduction a free nitro radical is generated which may be responsible for the antiprotozoal activity. The mechanism by which tinidazole exhibits activity against Giardia and Entamoeba species is not known.

    Thomson/Micromedex. Drug Information for the Health Care Professional. Volume 1, Greenwood Village, CO. 2006., p. 2831

    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - 250MG

    USFDA APPLICATION NUMBER - 21618

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    DOSAGE - TABLET;ORAL - 500MG

    USFDA APPLICATION NUMBER - 21618

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    ABOUT THIS PAGE

    Looking for 19387-91-8 / Tinidazole API manufacturers, exporters & distributors?

    Tinidazole manufacturers, exporters & distributors 1

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

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

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

    API | Excipient name

    Tinidazole

    Synonyms

    19387-91-8, Tindamax, Trimonase, Fasigyn, Tricolam, Fasigin

    Cas Number

    19387-91-8

    Unique Ingredient Identifier (UNII)

    033KF7V46H

    About Tinidazole

    A nitroimidazole alkylating agent that is used as an antitrichomonal agent against TRICHOMONAS VAGINALIS; ENTAMOEBA HISTOLYTICA; and GIARDIA LAMBLIA infections. It also acts as an antibacterial agent for the treatment of BACTERIAL VAGINOSIS and anaerobic bacterial infections.

    DSSTox_CID_3676 Manufacturers

    A DSSTox_CID_3676 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of DSSTox_CID_3676, including repackagers and relabelers. The FDA regulates DSSTox_CID_3676 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. DSSTox_CID_3676 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 DSSTox_CID_3676 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    DSSTox_CID_3676 Suppliers

    A DSSTox_CID_3676 supplier is an individual or a company that provides DSSTox_CID_3676 active pharmaceutical ingredient (API) or DSSTox_CID_3676 finished formulations upon request. The DSSTox_CID_3676 suppliers may include DSSTox_CID_3676 API manufacturers, exporters, distributors and traders.

    click here to find a list of DSSTox_CID_3676 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    DSSTox_CID_3676 USDMF

    A DSSTox_CID_3676 DMF (Drug Master File) is a document detailing the whole manufacturing process of DSSTox_CID_3676 active pharmaceutical ingredient (API) in detail. Different forms of DSSTox_CID_3676 DMFs exist exist since differing nations have different regulations, such as DSSTox_CID_3676 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A DSSTox_CID_3676 DMF submitted to regulatory agencies in the US is known as a USDMF. DSSTox_CID_3676 USDMF includes data on DSSTox_CID_3676's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The DSSTox_CID_3676 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of DSSTox_CID_3676 suppliers with USDMF on PharmaCompass.

    DSSTox_CID_3676 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 DSSTox_CID_3676 Drug Master File in Japan (DSSTox_CID_3676 JDMF) empowers DSSTox_CID_3676 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 DSSTox_CID_3676 JDMF during the approval evaluation for pharmaceutical products. At the time of DSSTox_CID_3676 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 DSSTox_CID_3676 suppliers with JDMF on PharmaCompass.

    DSSTox_CID_3676 CEP

    A DSSTox_CID_3676 CEP of the European Pharmacopoeia monograph is often referred to as a DSSTox_CID_3676 Certificate of Suitability (COS). The purpose of a DSSTox_CID_3676 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of DSSTox_CID_3676 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of DSSTox_CID_3676 to their clients by showing that a DSSTox_CID_3676 CEP has been issued for it. The manufacturer submits a DSSTox_CID_3676 CEP (COS) as part of the market authorization procedure, and it takes on the role of a DSSTox_CID_3676 CEP holder for the record. Additionally, the data presented in the DSSTox_CID_3676 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the DSSTox_CID_3676 DMF.

    A DSSTox_CID_3676 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. DSSTox_CID_3676 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 DSSTox_CID_3676 suppliers with CEP (COS) on PharmaCompass.

    DSSTox_CID_3676 WC

    A DSSTox_CID_3676 written confirmation (DSSTox_CID_3676 WC) is an official document issued by a regulatory agency to a DSSTox_CID_3676 manufacturer, verifying that the manufacturing facility of a DSSTox_CID_3676 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting DSSTox_CID_3676 APIs or DSSTox_CID_3676 finished pharmaceutical products to another nation, regulatory agencies frequently require a DSSTox_CID_3676 WC (written confirmation) as part of the regulatory process.

    click here to find a list of DSSTox_CID_3676 suppliers with Written Confirmation (WC) on PharmaCompass.

    DSSTox_CID_3676 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 DSSTox_CID_3676 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for DSSTox_CID_3676 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 DSSTox_CID_3676 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 DSSTox_CID_3676 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a DSSTox_CID_3676 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of DSSTox_CID_3676 suppliers with NDC on PharmaCompass.

    DSSTox_CID_3676 GMP

    DSSTox_CID_3676 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 DSSTox_CID_3676 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 DSSTox_CID_3676 GMP manufacturer or DSSTox_CID_3676 GMP API supplier for your needs.

    DSSTox_CID_3676 CoA

    A DSSTox_CID_3676 CoA (Certificate of Analysis) is a formal document that attests to DSSTox_CID_3676's compliance with DSSTox_CID_3676 specifications and serves as a tool for batch-level quality control.

    DSSTox_CID_3676 CoA mostly includes findings from lab analyses of a specific batch. For each DSSTox_CID_3676 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.

    DSSTox_CID_3676 may be tested according to a variety of international standards, such as European Pharmacopoeia (DSSTox_CID_3676 EP), DSSTox_CID_3676 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (DSSTox_CID_3676 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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