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    Also known as: 134678-17-4, Epivir, Zeffix, Heptovir, Epivir-hbv, 136891-12-8
    Molecular Formula
    C8H11N3O3S
    Molecular Weight
    229.26  g/mol
    InChI Key
    JTEGQNOMFQHVDC-NKWVEPMBSA-N
    FDA UNII
    2T8Q726O95
    Lamivudine
    A reverse transcriptase inhibitor and ZALCITABINE analog in which a sulfur atom replaces the 3' carbon of the pentose ring. It is used to treat HIV disease.
    Lamivudine is a Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor and Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor. The mechanism of action of lamivudine is as a Nucleoside Reverse Transcriptase Inhibitor.
    1 2D Structure

    Lamivudine

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-amino-1-[(2R,5S)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2-one
    2.1.2 InChI
    InChI=1S/C8H11N3O3S/c9-5-1-2-11(8(13)10-5)6-4-15-7(3-12)14-6/h1-2,6-7,12H,3-4H2,(H2,9,10,13)/t6-,7+/m0/s1
    2.1.3 InChI Key
    JTEGQNOMFQHVDC-NKWVEPMBSA-N
    2.1.4 Canonical SMILES
    C1C(OC(S1)CO)N2C=CC(=NC2=O)N
    2.1.5 Isomeric SMILES
    C1[C@H](O[C@H](S1)CO)N2C=CC(=NC2=O)N
    2.2 Other Identifiers
    2.2.1 UNII
    2T8Q726O95
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2',3' Dideoxy 3' Thiacytidine

    2. 2',3'-dideoxy-3'-thiacytidine

    3. 2(1h)-pyrimidinone, 4-amino-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, (2r-cis)-

    4. 3tc Lamivudine

    5. Bch 189

    6. Bch-189

    7. Bch189

    8. Epivir

    9. Gr 109714x

    10. Gr-109714x

    11. Gr109714x

    12. Lamivudine, (+)-cis-

    13. Lamivudine, (+-)-trans-

    14. Lamivudine, (2s-cis)-isomer

    15. Lamivudine, 3tc

    2.3.2 Depositor-Supplied Synonyms

    1. 134678-17-4

    2. Epivir

    3. Zeffix

    4. Heptovir

    5. Epivir-hbv

    6. 136891-12-8

    7. 3tc

    8. Bch-189

    9. Heptodin

    10. 4-amino-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1h)-one

    11. (-)-2'-deoxy-3'-thiacytidine

    12. Virolam

    13. Gr-109714x

    14. 3'-thia-2',3'-dideoxycytidine

    15. Gr109714x

    16. (-)-bch-189

    17. Beta-l-2',3'-dideoxy-3'-thiacytidine

    18. Beta-l-3'-thia-2',3'-dideoxycytidine

    19. 2',3'-dideoxy-3'-thiacytidine

    20. Gr 109714x

    21. Lamivudine Teva

    22. 4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2-one

    23. (-)ngpb-21

    24. Bch 189, (-)-

    25. (-)-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)cytosine

    26. 4-amino-1-(cis-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1h)-one

    27. 4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-1,2-dihydropyrimidin-2-one

    28. Hepitec

    29. 4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]pyrimidin-2(1h)-one

    30. 4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1h)-pyrimidinone

    31. Chebi:63577

    32. (-)-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine

    33. 4-amino-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-2(1h)-pyrimidinone

    34. 2(1h)-pyrimidinone, 4-amino-1-(2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-, (2r-cis)-

    35. 2t8q726o95

    36. Nsc-760061

    37. Heptivir

    38. Lamivir

    39. Zefix

    40. Bch 189

    41. Lamivudine [usan:ban:inn]

    42. (-)-(2'r,5's)-1-[2'-hydroxymethyl-5'-(1,3-oxathiolanyl)]cytosine

    43. 2(1h)-pyrimidinone, 4-amino-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)-

    44. 2(1h)-pyrimidinone, 4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-

    45. Epivir(tm)

    46. Hha & Lamivudine

    47. Lamivudine & Gna

    48. Smr000466319

    49. Epivir (tn)

    50. (-)-bch 189

    51. Dthc

    52. Chembl141

    53. Hsdb 7155

    54. Drg-0126

    55. 3tc And Nv-01

    56. (-)-sddc

    57. Lamivudeine

    58. Lamivudinum

    59. Lamivudine (jan/usp/inn)

    60. 3tc & Gna

    61. 3tc & Sst

    62. Hha & 3tc

    63. (+/-)-sddc

    64. Ccris 9274

    65. Nsc620753

    66. Unii-2t8q726o95

    67. Bch-790

    68. Lamivudine [usan:usp:inn:ban]

    69. Rac-cis-lamivudine

    70. Ncgc00159341-04

    71. Lamivudine- Bio-x

    72. Gg-714

    73. Mfcd00869739

    74. Lamivudine (epivir)

    75. Cpd000466319

    76. Lamivudine [mi]

    77. (+/-)-3tc

    78. (+/-)-bch-189

    79. Lamivudine [inn]

    80. Lamivudine [jan]

    81. Lamivudine [hsdb]

    82. Lamivudine [usan]

    83. Lamivudine [vandf]

    84. Lamivudine [mart.]

    85. Lamivudine [usp-rs]

    86. Lamivudine [who-dd]

    87. Lamivudine [who-ip]

    88. Mls000759424

    89. Mls001424097

    90. Mls006011910

    91. Bidd:gt0033

    92. Lamivudine [ema Epar]

    93. Schembl109675

    94. Amy384

    95. Dtxsid7023194

    96. Lamivudine [ep Impurity]

    97. Lamivudine [orange Book]

    98. Zinc12346

    99. Lamivudine [ep Monograph]

    100. Kivexa Component Lamivudine

    101. Hms2051d21

    102. Hms3259f08

    103. Hms3713c16

    104. Lamivudine [usp Monograph]

    105. Epzicom Component Lamivudine

    106. Lamivudinum [who-ip Latin]

    107. Temixys Component Lamivudine

    108. Triumeq Component Lamivudine

    109. Combivir Component Lamivudine

    110. Hy-b0250

    111. Lamivudine Teva Pharma B.v.

    112. Trizivir Component Lamivudine

    113. Bbl033871

    114. Bdbm50366817

    115. Delstrigo Component Lamivudine

    116. Mfcd00870542

    117. S1706

    118. Stk801940

    119. Lamivudine & Tnf-alpha & Ifn-gamma

    120. Telura Component Of Lamivudine

    121. Akos005622556

    122. Akos015854841

    123. Lamivudine Component Of Epzicom

    124. Lamivudine Component Of Temixys

    125. Lamivudine Component Of Triumeq

    126. Lamivudine, >=98% (hplc), Powder

    127. (-)-bch189

    128. Ac-1416

    129. Ccg-100984

    130. Db00709

    131. Ks-1073

    132. Lamivudine Component Of Combivir

    133. Lamivudine Component Of Dutrebis

    134. Lamivudine Component Of Trizivir

    135. Nc00234

    136. Nc00705

    137. Nsc 760061

    138. Lamivudine Component Of Delstrigo

    139. Ncgc00159341-05

    140. Ncgc00159341-18

    141. Ncgc00159341-20

    142. Bl164607

    143. Emtricitabine Impurity C [who-ip]

    144. L0217

    145. Rac-cis-lamivudine ((2rs,5sr)-lamivudine)

    146. Sw197614-3

    147. C07065

    148. D00353

    149. P17147

    150. Ab00639995-06

    151. Ab00639995-08

    152. Ab00639995_09

    153. Lamivudeine 100 Microg/ml In Acetonitrile:water

    154. 678l174

    155. Q422631

    156. Sr-01000759420

    157. J-700183

    158. Q-201275

    159. Sr-01000759420-5

    160. Lamivudine/zidovudine Teva Component Lamivudine

    161. Lamivudine Component Of Lamivudine/zidovudine Teva

    162. Lamivudine, British Pharmacopoeia (bp) Reference Standard

    163. Lamivudine, European Pharmacopoeia (ep) Reference Standard

    164. (2r,5s)-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine

    165. .beta.-l-(-)-2',3'-dideoxy-3'-thiacytidine & Sho-saiko-to

    166. Lamivudine, United States Pharmacopeia (usp) Reference Standard

    167. (+/-) (cis)-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]cytosine

    168. (-)-l-2',3'-dideoxy-3'-thiacytidine; Lamivudine; Epivir

    169. Lamivudine, 1.0 Mg/ml In Methanol, Certified Reference Material

    170. Lamivudine, Pharmaceutical Secondary Standard; Certified Reference Material

    171. (+/-)-(cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1h)-pyrimidin-2-one

    172. 2(1h)-pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (+/-) (cis)

    173. 4-amino-1-[(2r,5s)-2-(hydroxymethyl)-[1,3]-oxathiolan-5-yl]-(1h)-pyrimidin-2-one

    174. 4-amino-1-[(2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-(1h)-pyrimidin-2-one

    175. Cis(+/-)-4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl]-2(1h)-pyrimidinone

    176. Lamivudine For System Suitability 1, European Pharmacopoeia (ep) Reference Standard

    177. Lamivudine For System Suitability 2, European Pharmacopoeia (ep) Reference Standard

    178. 1117764-41-6

    179. 2(1h)-pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (-)(2r,5s) & Galanthus Nivalis Agglutinin (gna)

    180. 2(1h)-pyrimidinone, 4-amino-1-[2-(hydroxymethyl)-1,3-oxathiolan-5-yl], (-)(2r,5s) & Hippeastrum Hybrid Agglutinin( Hha)

    181. 4-amino-1-((2r,5s)-2-(hydroxymethyl)-1,3-oxathiolan-5-yl)pyrimidin-2(1h)-one [who-ip]

    2.4 Create Date
    2005-08-01
    3 Chemical and Physical Properties
    Molecular Weight 229.26 g/mol
    Molecular Formula C8H11N3O3S
    XLogP3-0.9
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count4
    Rotatable Bond Count2
    Exact Mass229.05211239 g/mol
    Monoisotopic Mass229.05211239 g/mol
    Topological Polar Surface Area113 Ų
    Heavy Atom Count15
    Formal Charge0
    Complexity331
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    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 NameEpivir
    Drug LabelEPIVIR-HBV is a brand name for lamivudine, a synthetic nucleoside analogue with activity against hepatitis B virus (HBV) and HIV. Lamivudine was initially developed for the treatment of HIV infection as EPIVIR. Please see the complete prescribing inf...
    Active IngredientLamivudine
    Dosage FormTablet; Solution
    RouteOral
    Strength300mg; 150mg; 10mg/ml
    Market StatusPrescription
    CompanyViiv Hlthcare

    2 of 6  
    Drug NameEpivir-hbv
    PubMed HealthLamivudine (By mouth)
    Drug ClassesAntiretroviral Agent, Antiviral
    Drug LabelEPIVIR-HBV is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidi...
    Active IngredientLamivudine
    Dosage FormTablet; Solution
    RouteOral
    Strength5mg/ml; 100mg
    Market StatusPrescription
    CompanyGlaxosmithkline

    3 of 6  
    Drug NameLamivudine
    PubMed HealthLamivudine (By mouth)
    Drug ClassesAntiretroviral Agent, Antiviral
    Drug LabelEPIVIR-HBV is a brand name for lamivudine, a synthetic nucleoside analogue with activity against hepatitis B virus (HBV) and HIV. Lamivudine was initially developed for the treatment of HIV infection as EPIVIR. Please see the complete prescribing inf...
    Active IngredientLamivudine
    Dosage FormTablet; Solution
    Routeoral; Oral
    Strength150mg; 10mg/ml; 300mg; 100mg
    Market StatusTentative Approval; Prescription
    CompanyRanbaxy; Hetero Labs Ltd V; Macleods Pharma; Apotex; Aurobindo; Hetero Labs Ltd Iii; Alkem Labs; Aurobindo Pharma; Invagen Pharms; Cipla; Matrix Labs; Teva Pharms; Strides Arcolab; Micro Labs

    4 of 6  
    Drug NameEpivir
    Drug LabelEPIVIR-HBV is a brand name for lamivudine, a synthetic nucleoside analogue with activity against hepatitis B virus (HBV) and HIV. Lamivudine was initially developed for the treatment of HIV infection as EPIVIR. Please see the complete prescribing inf...
    Active IngredientLamivudine
    Dosage FormTablet; Solution
    RouteOral
    Strength300mg; 150mg; 10mg/ml
    Market StatusPrescription
    CompanyViiv Hlthcare

    5 of 6  
    Drug NameEpivir-hbv
    PubMed HealthLamivudine (By mouth)
    Drug ClassesAntiretroviral Agent, Antiviral
    Drug LabelEPIVIR-HBV is a synthetic nucleoside analogue with activity against HBV. The chemical name of lamivudine is (2R,cis)-4-amino-1-(2-hydroxymethyl-1,3-oxathiolan-5-yl)-(1H)-pyrimidin-2-one. Lamivudine is the (-)enantiomer of a dideoxy analogue of cytidi...
    Active IngredientLamivudine
    Dosage FormTablet; Solution
    RouteOral
    Strength5mg/ml; 100mg
    Market StatusPrescription
    CompanyGlaxosmithkline

    6 of 6  
    Drug NameLamivudine
    PubMed HealthLamivudine (By mouth)
    Drug ClassesAntiretroviral Agent, Antiviral
    Drug LabelEPIVIR-HBV is a brand name for lamivudine, a synthetic nucleoside analogue with activity against hepatitis B virus (HBV) and HIV. Lamivudine was initially developed for the treatment of HIV infection as EPIVIR. Please see the complete prescribing inf...
    Active IngredientLamivudine
    Dosage FormTablet; Solution
    Routeoral; Oral
    Strength150mg; 10mg/ml; 300mg; 100mg
    Market StatusTentative Approval; Prescription
    CompanyRanbaxy; Hetero Labs Ltd V; Macleods Pharma; Apotex; Aurobindo; Hetero Labs Ltd Iii; Alkem Labs; Aurobindo Pharma; Invagen Pharms; Cipla; Matrix Labs; Teva Pharms; Strides Arcolab; Micro Labs

    4.2 Therapeutic Uses

    Lamivudine is indicated in the treatment of chronic hepatitis B associated with evidence of hepatitis B viral replication and active liver inflammation. This use is based on 1-year histologic and serologic responses in patients with compensated chronic hepatitis B. /Included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1646

    Lamivudine is indicated, in combination with zidovudine or other antiretroviral agents, in the treatment of HIV infection or AIDS when therapy is warranted based on clinical and/or immunological evidence of disease progression. /Included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1646

    Lamivudine may be used prophylactically in health care workers at risk of acquiring HIV infection after occupational exposure to the virus. It is being used in combination with zidovudine and, in some cases, a protease inhibitor. /NOT included in US product labeling/

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1646

    The safety, pharmacokinetics, and antiretroviral activity of lamivudine alone and in combination with zidovudine was studied in pregnant women infected with human immunodeficiency virus type 1 (HIV-1) and their neonates. Women received the drugs orally from week 38 of pregnancy to 1 week after delivery. Neonate therapy began 12 h after delivery and continued for 1 week. Both treatment regimens were well-tolerated in women and newborns. Lamivudine and zidovudine pharmacokinetics in pregnant women were similar to those in nonpregnant adults. Lamivudine and zidovudine freely crossed the placenta and were secreted in breast milk. Neonatal lamivudine clearance was about half that in pediatric patients; zidovudine clearance was consistent with previous reports. HIV-1 RNA could be quantified in 17 of the 20 women. At the onset of labor/delivery, mean virus load had decreased by approximately 1.5 log10 copies/mL in both treatment cohorts. Although not definitive for HIV-1 infection status, all neonates had HIV-1 RNA levels below the limit of quantification at birth and at ages 1 and 2 weeks.

    PMID:9780252 Moodley J et al; J Infect Dis 178 (5): 1327-33 (1998)

    4.3 Drug Warning

    Safety and efficacy of lamivudine in the treatment of chronic hepatitis B have not been established in patients with decompensated liver disease or organ transplants; pediatric patients; or patients dually infected with hepatitis B and hepatitis C, hepatitis delta, or HIV; or for a treatment period greater than 1 year.

    MICROMEDEX Thomson Health Care. USPDI - Drug Information for the Health Care Professional. 23rd ed. Volume 1. MICROMEDEX Thomson Health Care, Greenwood Village, CO. 2003. Content Reviewed and Approved by the U.S. Pharmacopeial Convention, Inc., p. 1646

    Although lamivudine generally is well tolerated, serious adverse effects such as peripheral neuropathy, pancreatitis, and lactic acidosis and severe hepatomegaly with steatosis have been reported. Adverse GI effects are the most common adverse effects in patients receiving lamivudine alone or in conjunction with zidovudine. Information on adverse effects of lamivudine has been obtained from clinical studies in HIV-infected adults who received the drug in conjunction with other antiretroviral agents ... . In addition, information on adverse effects of lamivudine in patients with compensated chronic hepatitis B virus (HBV) infection has been obtained from 3 placebo-controlled studies where the drug was used alone for up to 68 weeks.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 668

    Peripheral neuropathy, the major dose-limiting toxicity associated with zalcitabine therapy, has been reported in adults receiving lamivudine, but has rarely resulted in interruption or discontinuance of therapy. In clinical studies... in HIV-infected adults receiving lamivudine in conjunction with zidovudine, neuropathy was reported in 12% of the patients. Paresthesia, weakness, and peripheral neuropathy have been reported in patients receiving lamivudine during postmarketing surveillance. ... In clinical studies in adults who received lamivudine for the treatment of chronic /hepatitis B virus/ (HBV) infection, malaise, fatigue, and headache were reported in 24, 24, and 21% of patients, respectively.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 668

    In HIV-infected adults receiving lamivudine in conjunction with zidovudine, headache, malaise, fatigue, insomnia and other sleep disorders, dizziness, and depressive disorders were reported in 35, 27, 27, 11, 10, and 9%, respectively.

    McEvoy, G.K. (ed.). American Hospital Formulary Service - Drug Information 2003. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2003 (Plus Supplements)., p. 668

    For more Drug Warnings (Complete) data for LAMIVUDINE (20 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the treatment of HIV infection and chronic hepatitis B (HBV).

    FDA Label

    Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.

    Lamivudine Teva Pharma B. V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.

    Zeffix is indicated for the treatment of chronic hepatitis B in adults with:

    - compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;

    - decompensated liver disease in combination with a second agent without cross-resistance to lamivudine.

    Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with:

    - compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5. 1).

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Lamivudine is a nucleoside reverse transcriptase inhibitor (NRTI) with activity against Human Immunodeficiency Virus Type 1 (HIV-1) and hepatitis B (HBV) to disrupt viral DNA synthesis. When phosphorylated, lamivudine can form active metabolites that compete for incorporation into viral DNA. Via DNA incorporation, lamivudine metabolites competitively inhibit the activity of the HIV reverse transcriptase enzyme and act as a chain terminator of DNA synthesis. Due to the lack of a 3'-OH group, incorporated nucleoside analogues prevent the formation of a 5' to 3' phosphodiester linkage that is essential for DNA chain elongation.

    5.2 MeSH Pharmacological Classification

    Anti-HIV Agents

    Agents used to treat AIDS and/or stop the spread of the HIV infection. These do not include drugs used to treat symptoms or opportunistic infections associated with AIDS. (See all compounds classified as Anti-HIV Agents.)

    Reverse Transcriptase Inhibitors

    Inhibitors of reverse transcriptase (RNA-DIRECTED DNA POLYMERASE), an enzyme that synthesizes DNA on an RNA template. (See all compounds classified as Reverse Transcriptase Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    LAMIVUDINE
    5.3.2 FDA UNII
    2T8Q726O95
    5.3.3 Pharmacological Classes
    Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]; Nucleoside Analog [EXT]; Nucleoside Reverse Transcriptase Inhibitors [MoA]; Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
    5.4 ATC Code

    J05AF05

    J05AF05

    J05AF05

    J05AF05

    J - Antiinfectives for systemic use

    J05 - Antivirals for systemic use

    J05A - Direct acting antivirals

    J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors

    J05AF05 - Lamivudine

    5.5 Absorption, Distribution and Excretion

    Absorption

    Lamivudine was rapidly absorbed after oral administration in HIV-infected patients. Absolute bioavailability in 12 adult patients was 86% 16% (mean SD) for the 150-mg tablet and 87% 13% for the oral solution. The peak serum lamivudine concentration (Cmax) was 1.5 0.5 mcg/mL when an oral dose of 2 mg/kg twice a day was given to HIV-1 patients. When given with food, absorption is slower, compared to the fasted state.

    Route of Elimination

    The majority of lamivudine is eliminated unchanged in urine by active organic cationic secretion. 5.2% 1.4% (mean SD) of the dose was excreted as the trans-sulfoxide metabolite in the urine. Lamivudine is excreted in human breast milk and into the milk of lactating rats.

    Volume of Distribution

    Apparent volume of distribution, IV administration = 1.3 0.4 L/kg. Volume of distribution was independent of dose and did not correlate with body weight.

    Clearance

    Renal clearance = 199.7 56.9 mL/min [300 mg oral dose, healthy subjects]

    Renal clearance = 280.4 75.2 mL/min [single IV dose, HIV-1-infected patients]

    Total clearance = 398.5 69.1 mL/min [HIV-1-infected patients]

    Lamivudine crosses the placenta and has been detected in the fetal circulation.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1359

    Lamivudine has high oral bioavailability with or without food and reaches peak plasma levels within approximately 1 hour.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1359

    5.6 Metabolism/Metabolites

    Metabolism of lamivudine is a minor route of elimination. In man, the only known metabolite of lamivudine is the trans-sulfoxide metabolite. This biotransformation is catalyzed by sulfotransferases.

    5.7 Biological Half-Life

    5 to 7 hours (healthy or HBV-infected patients)

    5.8 Mechanism of Action

    Lamivudine is a synthetic nucleoside analogue and is phosphorylated intracellularly to its active 5'-triphosphate metabolite, lamivudine triphosphate (L-TP). This nucleoside analogue is incorporated into viral DNA by HIV reverse transcriptase and HBV polymerase, resulting in DNA chain termination.

    Lamivudine enters cells by passive diffusion and is phosphorylated to its active metabolite, lamivudine triphosphate. Lamivudine triphosphate competes with deoxycytidine triphosphate for binding to reverse transcriptase, and incorporation into DNA results in chain termination. Lamivudine has very low affinity for human alpha and omega DNA polymerases, moderate affinity for beta DNA polymerase, and higher affinity for gamma DNA polymerase.

    Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1358

    API SUPPLIERS

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    LGM Pharma

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    LONZEAL PHARMACEUTICALS CO LTD

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    SIBRA PHARMACEUTICALS LTD

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    SIBRA PHARMACEUTICALS LTD

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    Anhui Biochem Pharmaceutical

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    INTERMEDIATE SUPPLIERS

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    Riddhi Pharma

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    MONO BROMO ACETIC ACID

    CAS Number : 79-08-3

    End Use API : Lamivudine

    About The Company : Riddhi Pharma was set up in 1997 as a Manufacturer of API’s Intermediates and Fine Chemicals, especially in the field of Friedel Crafts Reaction / Bromination...

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    Shandong Boyuan Pharmaceutical

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    (R)-(-)-2,2-Dimethyl-1,3-dioxolane-4-methanol

    CAS Number : 14347-78-5

    End Use API : Lamivudine

    About The Company : We are one of the well-known manufacturers of key APIs & intermediates in China, with 20 years of experience & presence in 20+ countries. At Boyuan, we are comm...

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    Zhejiang NHU Co

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    L-Menthol

    CAS Number : 2216-51-5

    End Use API : Lamivudine

    About The Company : Zhejiang NHU Co., Ltd. was founded in 1999 and listed in 2004 (stock code 002001). Since its establishment, the company has always adhered to the concept of inn...

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    DOSAGE - TABLET;ORAL - EQ 600MG BASE;EQ 50MG ...DOSAGE - TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

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    DOSAGE - TABLET;ORAL - EQ 600MG BASE;300MG **...DOSAGE - TABLET;ORAL - EQ 600MG BASE;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

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    ABOUT THIS PAGE

    Looking for 134678-17-4 / Lamivudine API manufacturers, exporters & distributors?

    Lamivudine manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Lamivudine 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 Lamivudine manufacturer or Lamivudine supplier for your needs.

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

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

    API | Excipient name

    Lamivudine

    Synonyms

    134678-17-4, Epivir, Zeffix, Heptovir, Epivir-hbv, 136891-12-8

    Cas Number

    134678-17-4

    Unique Ingredient Identifier (UNII)

    2T8Q726O95

    About Lamivudine

    A reverse transcriptase inhibitor and ZALCITABINE analog in which a sulfur atom replaces the 3' carbon of the pentose ring. It is used to treat HIV disease.

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets Manufacturers

    A Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets, including repackagers and relabelers. The FDA regulates Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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 Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets Suppliers

    A Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets supplier is an individual or a company that provides Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets active pharmaceutical ingredient (API) or Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets finished formulations upon request. The Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets suppliers may include Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets API manufacturers, exporters, distributors and traders.

    click here to find a list of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets USDMF

    A Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets DMF (Drug Master File) is a document detailing the whole manufacturing process of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets active pharmaceutical ingredient (API) in detail. Different forms of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets DMFs exist exist since differing nations have different regulations, such as Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets DMF submitted to regulatory agencies in the US is known as a USDMF. Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets USDMF includes data on Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets suppliers with USDMF on PharmaCompass.

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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 Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets Drug Master File in Japan (Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets JDMF) empowers Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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 Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets JDMF during the approval evaluation for pharmaceutical products. At the time of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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 Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets suppliers with JDMF on PharmaCompass.

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets KDMF

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

    Pharmaceutical companies submit a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets Drug Master File in Korea (Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets. The MFDS reviews the Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets KDMF as part of the drug registration process and uses the information provided in the Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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 Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets suppliers with KDMF on PharmaCompass.

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CEP

    A Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CEP of the European Pharmacopoeia monograph is often referred to as a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets Certificate of Suitability (COS). The purpose of a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets to their clients by showing that a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CEP has been issued for it. The manufacturer submits a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CEP holder for the record. Additionally, the data presented in the Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets DMF.

    A Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

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    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets WC

    A Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets written confirmation (Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets WC) is an official document issued by a regulatory agency to a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets manufacturer, verifying that the manufacturing facility of a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets APIs or Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets finished pharmaceutical products to another nation, regulatory agencies frequently require a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets WC (written confirmation) as part of the regulatory process.

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    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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 Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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 Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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 Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets suppliers with NDC on PharmaCompass.

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets GMP

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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 Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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 Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets GMP manufacturer or Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets GMP API supplier for your needs.

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CoA

    A Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CoA (Certificate of Analysis) is a formal document that attests to Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets's compliance with Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets specifications and serves as a tool for batch-level quality control.

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets CoA mostly includes findings from lab analyses of a specific batch. For each Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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.

    Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets may be tested according to a variety of international standards, such as European Pharmacopoeia (Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets EP), Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lamivudine/Zidovudine 150 mg/300 mg Tablets Co-packaged with Nevirapine 200 mg Tablets 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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