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    Also known as: 1051375-16-6, Gsk1349572, S/gsk1349572, Tivicay, Gsk-1349572, Gsk 1349572
    Molecular Formula
    C20H19F2N3O5
    Molecular Weight
    419.4  g/mol
    InChI Key
    RHWKPHLQXYSBKR-BMIGLBTASA-N
    FDA UNII
    DKO1W9H7M1
    Dolutegravir Sodium
    Dolutegravir is an orally bioavailable integrase strand-transfer inhibitor (INSTI), with activity against human immunodeficiency virus type 1 (HIV-1) infection. Upon oral administration, dolutegravir binds to the active site of integrase, an HIV enzyme that catalyzes the transfer of viral genetic material into human chromosomes. This prevents integrase from binding to retroviral deoxyribonucleic acid (DNA), and blocks the strand transfer step, which is essential for the HIV replication cycle. This prevents HIV-1 replication.
    Dolutegravir is a Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor. The mechanism of action of dolutegravir is as a HIV Integrase Inhibitor, and Multidrug and Toxin Extrusion Transporter 1 Inhibitor, and Organic Cation Transporter 2 Inhibitor.
    1 2D Structure

    Dolutegravir Sodium

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3S,7R)-N-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.03,8]tetradeca-10,13-diene-13-carboxamide
    2.1.2 InChI
    InChI=1S/C20H19F2N3O5/c1-10-4-5-30-15-9-24-8-13(17(26)18(27)16(24)20(29)25(10)15)19(28)23-7-11-2-3-12(21)6-14(11)22/h2-3,6,8,10,15,27H,4-5,7,9H2,1H3,(H,23,28)/t10-,15+/m1/s1
    2.1.3 InChI Key
    RHWKPHLQXYSBKR-BMIGLBTASA-N
    2.1.4 Canonical SMILES
    CC1CCOC2N1C(=O)C3=C(C(=O)C(=CN3C2)C(=O)NCC4=C(C=C(C=C4)F)F)O
    2.1.5 Isomeric SMILES
    C[C@@H]1CCO[C@@H]2N1C(=O)C3=C(C(=O)C(=CN3C2)C(=O)NCC4=C(C=C(C=C4)F)F)O
    2.2 Other Identifiers
    2.2.1 UNII
    DKO1W9H7M1
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (4r,12as)-n-((2,4-difluorophenyl)methyl)-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido(1',2':4,5)pyrazino(2,1-b)(1,3)oxazine-9-carboxamide

    2. (4r,9as)-5-hydroxy-4-methyl-6,10-dioxo-3,4,6,9,9a,10-hexahydro-2h-1-oxa-4a,8a-diaza-anthracene-7-carboxylic Acid- 2,4 Difluorobenzylamide

    3. (4s,12ar)-n-((2,4-difluorophenyl)methyl)-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido(1',2':4,5)pyrazino(2,1-b)(1,3)oxazine-9-carboxamide

    4. (4s,12as)-n-((2,4-difluorophenyl)methyl)-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido(1',2':4,5)pyrazino(2,1-b)(1,3)oxazine-9-carboxamide

    5. Dolutegravir S,r Isomer

    6. Dolutegravir S,s-isomer

    7. Dolutegravir Sodium

    8. Dolutegravir Sodium Monohydrate

    9. Gsk 1349572a

    10. Gsk-1349572

    11. Gsk-1349572a

    12. Gsk1349572a

    13. S-gsk1349572

    14. Tivicay

    15. Tivicay Pd

    2.3.2 Depositor-Supplied Synonyms

    1. 1051375-16-6

    2. Gsk1349572

    3. S/gsk1349572

    4. Tivicay

    5. Gsk-1349572

    6. Gsk 1349572

    7. Dolutegravir (gsk1349572)

    8. S-349572

    9. (4r,12as)-n-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2h-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide

    10. Dolutegravir Dtg

    11. Dolutegravir [usan]

    12. Chebi:76010

    13. (4r,12as)-n-[(2,4-difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido[1',2':4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide

    14. Dko1w9h7m1

    15. Dolutegravir (usan)

    16. 1051375-16-6 (free)

    17. Tivicay (tn)

    18. (3s,7r)-n-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.0^{3,8}]tetradeca-10,13-diene-13-carboxamide

    19. (3s,7r)-n-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.03,8]tetradeca-10,13-diene-13-carboxamide

    20. S-gsk1349572

    21. Dolutegravir [usan:inn]

    22. Unii-dko1w9h7m1

    23. Soltegravir

    24. Hsdb 8152

    25. 3s3m

    26. 3s3n

    27. 3s3o

    28. (4r,12as)-n-[(2,4-difluorophenyl)methyl]-7-hydroxy-4-methyl-6,8-dioxo-3,4,12,12a-tetrahydro-2h-pyrido[[?]:[?]]pyrazino[[?]][1,3]oxazine-9-carboxamide

    29. Dolutegravir [mi]

    30. Dolutegravir [inn]

    31. Dolutegravir [vandf]

    32. Schembl82071

    33. Mls006011137

    34. Dolutegravir [who-dd]

    35. Gtpl7365

    36. Chembl1229211

    37. Dtxsid90909356

    38. Ex-a1695

    39. Bdbm50062551

    40. Mfcd20488027

    41. S2667

    42. Zinc58581064

    43. Akos025396657

    44. S/gsk-1349572

    45. Bcp9000620

    46. Ccg-268876

    47. Cs-0454

    48. Db08930

    49. Ncgc00346629-01

    50. Ncgc00346629-02

    51. 2h-pyrido(1',2':4,5)pyrazino(2,1-b)(1,3)oxazine-9-carboxamide, N-((2,4-difluorophenyl)methyl)-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-, (4r,12as)-

    52. Ac-28371

    53. As-75277

    54. Hy-13238

    55. Smr004702915

    56. S/gsk1349572,gsk1349572

    57. D10066

    58. A854801

    59. Q937224

    60. J-501471

    61. (3s,7r)-n-[(2,4-difluorophenyl)methyl]-11-hydroxy-7-methyl-9,12-dioxo-4-oxa-1,8-diazatricyclo[8.4.0.0(3),?]tetradeca-10,13-diene-13-carboxamide

    62. (4r,12.alpha.s)-n-((2,4-difluorophenyl)methyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12.alpha.-hexahydro-2h-pyrido(1',2':4,5)pyrazino(2,1-.beta.)(1,3)oxazine-9-carboxamide

    63. (4r,12as)-n-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2h-[1,3]oxazino[3,2-a]pyrido[1,2-d]pyrazine-9-carboxamide

    64. (4r,12as)-n-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2h-[1,3]oxazino[3,2-d]pyrido[1,2-a]pyrazine-9-carboxamide

    65. (4r,12as)-n-(2,4-difluorobenzyl)-7-hydroxy-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2h-pyrido[1,2:4,5]pyrazino[2,1-b][1,3]oxazine-9-carboxamide

    66. (4r,12as)-n-[(2,4-difluorophenyl)methyl]-3,4,6,8,12,12a-hexahydro-7-hydroxy-4-methyl-6,8-dioxo-2h-pyrido[1',2':4,5]pyrazino[2,1-b][1 ,3]oxazine-9-carboxamide

    67. (4r,12as)-n-[(2,4-difluorophenyl)methyl]-7-hydroxy-4-methyl-6,8-dioxo-3,4,12,12a-tetrahydro-2h-pyrido[5,6]pyrazino[2,6-b][1,3]oxazine-9-carboxamide

    2.4 Create Date
    2011-12-26
    3 Chemical and Physical Properties
    Molecular Weight 419.4 g/mol
    Molecular Formula C20H19F2N3O5
    XLogP32.4
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count3
    Exact Mass419.12927704 g/mol
    Monoisotopic Mass419.12927704 g/mol
    Topological Polar Surface Area99.2 Ų
    Heavy Atom Count30
    Formal Charge0
    Complexity829
    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 Therapeutic Uses

    HIV Integrase Inhibitors

    National Library of Medicine's Medical Subject Headings. Dolutegravir. Online file (MeSH, 2014). Available from, as of November 19, 2013: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html

    The recommended dose of TIVICAY in pediatric patients aged 12 years and older and weighing at least 40 kg is 50 mg administered orally once daily. If efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin are coadministered, the recommended dose of TIVICAY is 50 mg twice daily. Safety and efficacy of TIVICAY have not been established in pediatric patients younger than 12 years or weighing less than 40 kg, or in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir).

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    TIVICAY (dolutegravir) is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and children aged 12 years and older and weighing at least 40 kg. The following should be considered prior to initiating treatment with TIVICAY: Poor virologic response was observed in subjects treated with TIVICAY 50 mg twice daily with an integrase strand transfer inhibitor (INSTI)-resistance Q148 substitution plus 2 or more additional INSTI-resistance substitutions, including L74I/M, E138A/D/K/T, G140A/S, Y143H/R, E157Q, G163E/K/Q/R/S, or G193E/R.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Renal clearance of unchanged drug is a minor pathway of elimination for dolutegravir. In a trial comparing 8 subjects with severe renal impairment (CrCl <30 mL/min) with 8 matched healthy controls, AUC, Cmax, and C24 of dolutegravir were decreased by 40%, 23%, and 43%, respectively, compared with those in matched healthy subjects. The cause of this decrease is unknown. Population pharmacokinetic analysis using data from SAILING and VIKING-3 trials indicated that mild and moderate renal impairment had no clinically relevant effect on the exposure of dolutegravir. No dosage adjustment is necessary for treatment-naive or treatment-experienced and INSTI-naive patients with mild, moderate, or severe renal impairment or for INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance) with mild or moderate renal impairment. Caution is warranted for INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance [see Microbiology (12.4)]) with severe renal impairment, as the decrease in dolutegravir concentrations may result in loss of therapeutic effect and development of resistance to TIVICAY or other coadministered antiretroviral agents. Dolutegravir has not been studied in patients requiring dialysis.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Dolutegravir is primarily metabolized and eliminated by the liver. In a trial comparing 8 subjects with moderate hepatic impairment (Child-Pugh Score B) with 8 matched healthy controls, exposure of dolutegravir from a single 50-mg dose was similar between the 2 groups. No dosage adjustment is necessary for patients with mild to moderate hepatic impairment (Child-Pugh Score A or B). The effect of severe hepatic impairment (Child-Pugh Score C) on the pharmacokinetics of dolutegravir has not been studied. Therefore, TIVICAY is not recommended for use in patients with severe hepatic impairment.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    4.2 Drug Warning

    The Centers for Disease Control and Prevention recommend that HIV-1-infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Studies in lactating rats and their offspring indicate that dolutegravir was present in rat milk. It is not known whether dolutegravir is excreted in human milk. Because of both the potential for HIV transmission and the potential for adverse reactions in nursing infants, mothers should be instructed not to breastfeed if they are receiving TIVICAY.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, and dolutegravir was shown to cross the placenta in animal studies, this drug should be used during pregnancy only if clearly needed.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Dolutegravir (TIVICAY) should not be used with etravirine without coadministration of atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including TIVICAY. During the initial phase of combination antiretroviral treatment, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia (PCP), or tuberculosis), which may necessitate further evaluation and treatment. Autoimmune disorders (such as Graves' disease, polymyositis, and Guillain-Barre syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable and can occur many months after initiation of treatment.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    For more Drug Warnings (Complete) data for Dolutegravir (8 total), please visit the HSDB record page.

    4.3 Drug Indication

    Dolutegravir is indicated in combination with other antiretroviral agents for the treatment of patients with HIV-1 infection that comply with the characteristics of being adults or children aged 12 years and older and present at least a weight of 40 kg. The FDA combination therapy approval of dolutegravir and rilpivirine is indicated for adults with HIV-1 infections whose virus is currently suppressed (< 50 copies/ml) on a stable regimen for at least six months, without history of treatment failure and no known substitutions associated to resistance to any of the two components of the therapy.

    FDA Label

    Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg.

    Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    HIV-1 infected subjects on dolutegravir monotherapy demonstrated rapid and dose-dependent reduction of antiviral activity with declines of HIV-1 RNA copies per ml. The antiviral response was maintained for 3 to 4 days after the last dose. The sustained response obtained in clinical trials indicates that dolutegravir has a tight binding and longer dissociative half-life providing it a high barrier to resistance. The combination therapy (ripivirine and dolutegravir) presented the same viral suppression found in previous three-drug therapies without integrase strand transfer inhibitor mutations or rilpivirine resistance.

    5.2 MeSH Pharmacological Classification

    HIV Integrase Inhibitors

    Inhibitors of HIV INTEGRASE, an enzyme required for integration of viral DNA into cellular DNA. (See all compounds classified as HIV Integrase Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    DOLUTEGRAVIR
    5.3.2 FDA UNII
    DKO1W9H7M1
    5.3.3 Pharmacological Classes
    Mechanisms of Action [MoA] - Organic Cation Transporter 2 Inhibitors
    5.4 ATC Code

    J05AX12

    J - Antiinfectives for systemic use

    J05 - Antivirals for systemic use

    J05A - Direct acting antivirals

    J05AJ - Integrase inhibitors

    J05AJ03 - Dolutegravir

    5.5 Absorption, Distribution and Excretion

    Absorption

    When 50 mg of dolutegravir once daily was orally administered to HIV-1 infected adults, the AUC, Cmax, and Cmin is 53.6 mcg h/mL, 3.67 mcg/mL, and 1.11 mcg/mL, respectively. The peak plasma concentration was observed 2 to 3 hours post-dose. Steady state is achieved within approximately 5 days with average accumulation ratios for AUC, Cmax, and C24h ranging from 1.2 to 1.5. When 50 mg once daily is given to pediatric patients (12 to < 18 years and weighing 40 kg) the Cmax, AUC, and C24 is 3.49 mcg/mL, 46 mcg.h/mL, and 0.90 mcg/mL respectively.

    Route of Elimination

    When a single oral dose of dolutegravir is given, nearly all complete dose is recovered in a proportion of 53% excreted unchanged in the feces and 31% excreted in urine. The renal eliminated recovered dose consists of ether glucuronide of dolutegravir (18.9%), a metabolite formed by oxidation at the benzylic carbon (3.0%), a hydrolytic N-dealkylation product (3.6%) and unchanged drug (< 1%).

    Volume of Distribution

    The administration of a dose of 50 mg of dolutegravir presents an apparent volume of distribution of 17.4 L. The median dolutegravir concentration in CSF was 18 ng/mL after 2 weeks of treatment.

    Clearance

    The apparent clearance rate of dultegravir is 1.0 L/h.

    ... After a single oral dose of [14C] dolutegravir, 53% of the total oral dose was excreted unchanged in feces. Thirty-one percent of the total oral dose was excreted in urine, represented by an ether glucuronide of dolutegravir (18.9% of total dose), a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose), and its hydrolytic N-dealkylation product (3.6% of total dose). Renal elimination of unchanged drug was low (<1% of the dose).

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Dolutegravir is highly bound (=98.9%) to human plasma proteins based on in vivo data and binding is independent of plasma concentration of dolutegravir. The apparent volume of distribution (Vd/F) following 50-mg once-daily administration is estimated at 17.4 L based on a population pharmacokinetic analysis.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Food increased the extent of absorption and slowed the rate of absorption of dolutegravir. Low-, moderate-, and high-fat meals increased dolutegravir AUC(0-8) by 33%, 41%, and 66%; increased Cmax by 46%, 52%, and 67%; and prolonged Tmax to 3, 4, and 5 hours from 2 hours under fasted conditions, respectively.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    Following oral administration of dolutegravir, peak plasma concentrations were observed 2 to 3 hours postdose. With once-daily dosing, pharmacokinetic steady state is achieved within approximately 5 days with average accumulation ratios for AUC, Cmax, and C24 h ranging from 1.2 to 1.5. Dolutegravir plasma concentrations increased in a less than dose-proportional manner above 50 mg. Dolutegravir is a P-glycoprotein substrate in vitro. The absolute bioavailability of dolutegravir has not been established.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    5.6 Metabolism/Metabolites

    Dolutegravir is highly metabolized through three main pathways and it forms no long-lived metabolites. The first pathway is defined by the glucuronidation by UGT1A1, the second pathway by carbon oxidation by CYP3A4 and the third pathway is what appears to be a sequential oxidative defluorination and glutathione conjugation. The main metabolite found in blood plasma is the ether glucuronide form (M2) and its chemical properties disrupt its ability to bind metal ions, therefore, it is inactive.

    Dolutegravir is primarily metabolized via UGT1A1 with some contribution from CYP3A. ... ether glucuronide of dolutegravir (18.9% of total dose), a metabolite formed by oxidation at the benzylic carbon (3.0% of total dose), and its hydrolytic N-dealkylation product (3.6% of total dose). ...

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    5.7 Biological Half-Life

    The half-life of dolutegravir is 14 hours.

    Dolutegravir has a terminal half-life of approximately 14 hours and an apparent clearance (CL/F) of 1.0 L/h based on population pharmacokinetic analyses.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

    5.8 Mechanism of Action

    Dolutegravir is an HIV-1 antiviral agent. It inhibits HIV integrase by binding to the active site and blocking the strand transfer step of retroviral DNA integration in the host cell. The strand transfer step is essential in the HIV replication cycle and results in the inhibition of viral activity. Dolutegravir has a mean EC50 value of 0.5 nM (0.21 ng/mL) to 2.1 nM (0.85 ng/mL) in peripheral blood mononuclear cells (PBMCs) and MT-4 cells.

    Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle. Strand transfer biochemical assays using purified HIV-1 integrase and pre-processed substrate DNA resulted in IC50 values of 2.7 nM and 12.6 nM.

    US Natl Inst Health; DailyMed. Current Medication Information for TIVICAY (dolutegravir sodium) tablet, film coated TIVICAY (dolutegravir) Tablets for Oral Use (Initial U.S. Approval: 2013). Available from, as of November 22, 2013: https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=63df5af3-b8ac-4e76-9830-2dbb340af922

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DRUGS","customerCountry":"INDIA","quantity":"1856.16","actualQuantity":"1856.16","unit":"KGS","unitRateFc":"206.2","totalValueFC":"386577.8","currency":"USD","unitRateINR":"17500","date":"17-Oct-2024","totalValueINR":"32482800","totalValueInUsd":"386577.8","indian_port":"Vizag-HIPL SEZ","hs_no":"29349990","bill_no":"6162498","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"HETERO INFRASTRUCTURE SEZ LTD NAKKAPALLI(MANDAL)ANAKAPALLIDISTRIC SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1730745000,"product":"DOLUTEGRAVIR SODIUM IHS","address":"HETERO CORPORATE, NO. 7-2-A2,,INDU","city":"HYDERABAD,TELANGANA","supplier":"HETERO LABS LTD UNIT IX,HETEROINFRASTRUCTURESEZLTD","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"441.06","actualQuantity":"441.06","unit":"KGS","unitRateFc":"206","totalValueFC":"91464.8","currency":"USD","unitRateINR":"17500","date":"05-Nov-2024","totalValueINR":"7718550","totalValueInUsd":"91464.8","indian_port":"Vizag-HIPL SEZ","hs_no":"29349990","bill_no":"6502284","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HIPL SEZ","supplierAddress":"PLOT-NO.2,NAKKAPALLI(MANDAL), N.NARASAPURAMVILLAGE,ANAKAPALLIDIST SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732041000,"product":"DOLUTEGRAVIR SODIUM F-1(DGS)MI IH","address":"Plot no 564-A-22, Road No 92 ,\u00a0 Jubilee Hills, Film Nagar, Shaikpet, ,\u00a0 Hyderabad , \u00a0HYDERABAD ,\u00a0 TELANGANA,\u00a0 500096","city":"","supplier":"TIANISH LABORATORIES PRIVATE LIMITED UNIT 10 SEZ","supplierCountry":"INDIA","foreign_port":"RPCIPL SEZ","customer":"TIANISH LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3203.56","actualQuantity":"3203.56","unit":"KGS","unitRateFc":"243","totalValueFC":"786804.3","currency":"USD","unitRateINR":"20726","date":"20-Nov-2024","totalValueINR":"66396984.56","totalValueInUsd":"786804.3","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29335990","bill_no":"6773417","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"RPCIPL SEZ","supplierAddress":"PLOT NO.86 VISAKHAPHARMACITY LTD PARAWADA MANDAL,ANAKAPALLI DIST SDNF India","customerAddress":"Plot no 564-A-22, Road No 92 ,\u00a0 Jubilee Hills, Film Nagar, Shaikpet, ,\u00a0 Hyderabad , \u00a0HYDERABAD ,\u00a0 TELANGANA,\u00a0 500096"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732473000,"product":"DOLUTEGRAVIR SODIUM F-I(DGS)MI IH","address":"564\/A\/22, ROAD NO.92","city":"HYDERABAD,ANDHRA PRADESH","supplier":"TIANISH LABORATORIES PRIVATE LIMITED UNIT 10 SEZ","supplierCountry":"INDIA","foreign_port":"RPCIPL SEZ","customer":"VIATRIS","customerCountry":"INDIA","quantity":"307.33","actualQuantity":"307.33","unit":"KGS","unitRateFc":"242.8","totalValueFC":"75481.2","currency":"USD","unitRateINR":"20726","date":"25-Nov-2024","totalValueINR":"6369721.58","totalValueInUsd":"75481.2","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29335990","bill_no":"6862060","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"RPCIPL SEZ","supplierAddress":"PLOT NO.86 VISAKHAPHARMACITY LTD PARAWADA MANDAL,ANAKAPALLI DIST SDNF India","customerAddress":"564\/A\/22, ROAD NO.92"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1732559400,"product":"DOLUTEGRAVIR SODIUM F-1(DGS)MI IH","address":"Plot no 564-A-22, Road No 92 ,\u00a0 Jubilee Hills, Film Nagar, Shaikpet, ,\u00a0 Hyderabad , \u00a0HYDERABAD ,\u00a0 TELANGANA,\u00a0 500096","city":"","supplier":"TIANISH LABORATORIES PRIVATE LIMITED UNIT 10 SEZ","supplierCountry":"INDIA","foreign_port":"RPCIPL SEZ","customer":"TIANISH LABORATORIES PRIVATE LIMITED","customerCountry":"INDIA","quantity":"3561.35","actualQuantity":"3561.35","unit":"KGS","unitRateFc":"242.8","totalValueFC":"874678.6","currency":"USD","unitRateINR":"20726","date":"26-Nov-2024","totalValueINR":"73812540.1","totalValueInUsd":"874678.6","indian_port":"Vizag-RPCIPL SEZ","hs_no":"29335990","bill_no":"6890474","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"RPCIPL SEZ","supplierAddress":"PLOT NO.86 VISAKHAPHARMACITY LTD PARAWADA MANDAL,ANAKAPALLI DIST SDNF India","customerAddress":"Plot no 564-A-22, Road No 92 ,\u00a0 Jubilee Hills, Film Nagar, Shaikpet, ,\u00a0 Hyderabad , \u00a0HYDERABAD ,\u00a0 TELANGANA,\u00a0 500096"}]
    05-Jan-2021
    28-Dec-2024
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

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

    API Imports and Exports

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

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    Drugs in Development

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    • Development Update
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Strides Receives Tentative USFDA Approval for Dolutegravir/ Lamivudine/Tenofovir Disproxil Fumurate Tablets

    Details:

    USFDA approved a combination drug Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate a complete regimen for treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs.


    Lead Product(s): Dolutegravir Sodium,Lamivudine,Tenofovir Disproxil Fumurate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 15, 2023

    Strides Pharma Science

    01

    Strides Pharma Science

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    • fda
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Lead Product(s) : Dolutegravir Sodium,Lamivudine,Tenofovir Disproxil Fumurate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Strides Receives Tentative USFDA Approval for Dolutegravir/ Lamivudine/Tenofovir Disproxil Fumurat...

    Details : USFDA approved a combination drug Dolutegravir, Lamivudine and Tenofovir Disproxil Fumurate a complete regimen for treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 15, 2023

    Strides Pharma Science

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    Virtual Booth

    • Development Update
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Strides Receives Tentative USFDA Approval for Dolutegravir Tablets

    Details:

    USFDA approved a generic verion of Dolutegravir for the treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs. It inhibits HIV-integrase which is necessary for viral cell replication.


    Lead Product(s): Dolutegravir Sodium

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Tivicay-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 14, 2023

    Strides Pharma Science

    02

    Strides Pharma Science

    India
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    Not Confirmed
    • fda
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    • WHO-GMP
    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

    Lead Product(s) : Dolutegravir Sodium

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Strides Receives Tentative USFDA Approval for Dolutegravir Tablets

    Details : USFDA approved a generic verion of Dolutegravir for the treatment of HIV‐1 infection in adults and pediatric patients weighing at least 35kgs. It inhibits HIV-integrase which is necessary for viral cell replication.

    Brand Name : Tivicay-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 14, 2023

    Strides Pharma Science

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    ViiV Healthcare Announces Dovato is Effective in Treatment-Naïve HIV

    Details:

    Dovato combines the IST inhibitor, dolutegravir with the NRT inhibitor, lamivudine, is the first and only oral, two-drug, single-tablet regimen available for 12 and older living with HIV.


    Lead Product(s): Dolutegravir Sodium,Lamivudine

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Dovato

    Study Phase: Phase IVProduct Type: Small molecule

    Sponsor: Fundación Huésped

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable November 11, 2024

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    03

    ViiV Healthcare

    United Kingdom
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    ViiV Healthcare

    United Kingdom
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    Lead Product(s) : Dolutegravir Sodium,Lamivudine

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Fundación Huésped

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ViiV Healthcare Announces Dovato is Effective in Treatment-Naïve HIV

    Details : Dovato combines the IST inhibitor, dolutegravir with the NRT inhibitor, lamivudine, is the first and only oral, two-drug, single-tablet regimen available for 12 and older living with HIV.

    Brand Name : Dovato

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    November 11, 2024

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    ViiV Healthcare Announces FDA Approval Of Dovato for Adolescents with HIV

    Details:

    Dovato (dolutegravir and lamivudine) is the first oral two-drug single-tablet regimen for people aged 12 and older living with HIV.


    Lead Product(s): Dolutegravir Sodium,Lamivudine

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Dovato

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable April 08, 2024

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    04

    ViiV Healthcare

    United Kingdom
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    ViiV Healthcare

    United Kingdom
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    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Dolutegravir Sodium,Lamivudine

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ViiV Healthcare Announces FDA Approval Of Dovato for Adolescents with HIV

    Details : Dovato (dolutegravir and lamivudine) is the first oral two-drug single-tablet regimen for people aged 12 and older living with HIV.

    Brand Name : Dovato

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    April 08, 2024

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    ACTG Launches Tuberculosis Drug Interaction Trial Among HIV Patients

    Details:

    Dolutegravir is a HIV type 1 integrase inhibitor, which is being evaluated in combination with daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide regimen for HIV-associated tuberculosis.


    Lead Product(s): Dolutegravir Sodium,Rifapentine,Moxifloxacin

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Tivicay

    Study Phase: Phase IIProduct Type: Small molecule

    Sponsor: ViiV Healthcare

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable February 14, 2024

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    05

    ACTG

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    ACTG

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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Dolutegravir Sodium,Rifapentine,Moxifloxacin

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : ViiV Healthcare

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    ACTG Launches Tuberculosis Drug Interaction Trial Among HIV Patients

    Details : Dolutegravir is a HIV type 1 integrase inhibitor, which is being evaluated in combination with daily rifapentine-moxifloxacin plus isoniazid and pyrazinamide regimen for HIV-associated tuberculosis.

    Brand Name : Tivicay

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    February 14, 2024

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    AHF Praises Colombia's Stand for Accessible HIV Treatment

    Details:

    Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.


    Lead Product(s): Dolutegravir Sodium

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Tivicay-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: AIDS Healthcare Foundation

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable October 06, 2023

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    06

    ViiV Healthcare

    United Kingdom
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    BIO Partnering at JPM
    Not Confirmed

    ViiV Healthcare

    United Kingdom
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    BIO Partnering at JPM
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Dolutegravir Sodium

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : AIDS Healthcare Foundation

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    AHF Praises Colombia's Stand for Accessible HIV Treatment

    Details : Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

    Brand Name : Tivicay-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    October 06, 2023

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    Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolutegravir (DTG)/Lamivudine (3TC), a Once-daily Treatment ...

    Details:

    The fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 6 kg.


    Lead Product(s): Abacavir,Dolutegravir Sodium,Lamivudine

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable September 05, 2023

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    07

    Viatris

    U.S.A
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    Not Confirmed

    Viatris

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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Abacavir,Dolutegravir Sodium,Lamivudine

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Viatris Announces U.S. FDA Tentative Approval of a Paediatric Formulation of Abacavir (ABC)/Dolute...

    Details : The fixed-dose combination of abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension is indicated for the treatment of HIV-1 infection in paediatric patients weighing at least 6 kg.

    Brand Name : Undisclosed

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    September 05, 2023

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    Lupin Gets US FDA Tentative Approval for Dolutegravir Tablets for Oral Suspension

    Details:

    Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.


    Lead Product(s): Dolutegravir Sodium

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Tivicay-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable July 04, 2023

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    08

    Lupin Ltd

    India
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    Not Confirmed

    Lupin Ltd

    India
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    BIO Partnering at JPM
    Not Confirmed
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    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Dolutegravir Sodium

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Gets US FDA Tentative Approval for Dolutegravir Tablets for Oral Suspension

    Details : Dolutegravir tablets is a HIV-1 integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

    Brand Name : Tivicay-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    July 04, 2023

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    Lupin Receives Tentative Approval From U.S. FDA for Dolutegravir, Emtricitabine and Tenofovir Alafenamide (DETAF) Tablets

    Details:

    The combination inhibits HIV-1 replication, in which dolutegravir inhibits HIV integrase and blocks the strand transfer step of retroviral DNA integration where emtricitabine and tenofovir alafenamide inhibits the activity of the HIV-1 reverse transcriptase.


    Lead Product(s): Dolutegravir Sodium,Emtricitabine,Tenofovir Alafenamide

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Dolutegravir/Emtricitabine/Tenofovir Alafenamide-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 31, 2023

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    09

    Lupin Ltd

    India
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    Not Confirmed

    Lupin Ltd

    India
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    BIO Partnering at JPM
    Not Confirmed
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    Lead Product(s) : Dolutegravir Sodium,Emtricitabine,Tenofovir Alafenamide

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Receives Tentative Approval From U.S. FDA for Dolutegravir, Emtricitabine and Tenofovir Alaf...

    Details : The combination inhibits HIV-1 replication, in which dolutegravir inhibits HIV integrase and blocks the strand transfer step of retroviral DNA integration where emtricitabine and tenofovir alafenamide inhibits the activity of the HIV-1 reverse transcript...

    Brand Name : Dolutegravir/Emtricitabine/Tenofovir Alafenamide-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 31, 2023

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    Lupin Receives Tentative Approval from U.S. FDA for Dolutegravir and Rilpivirine Tablets

    Details:

    Dolutegravir Sodium, where dolutegravir is an integrase inhibitor while rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which is used as an oral combination for the treatment of HIV-1 infections in treatment-naive patients.


    Lead Product(s): Dolutegravir Sodium,Rilpivirine Hydrochloride

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Dolutegravir/Rilpivirine-Generic

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: Not Applicable

    Deal Size: Not Applicable Upfront Cash: Not Applicable

    Deal Type: Not Applicable January 16, 2023

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    Lupin Ltd

    India
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    India
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    Lead Product(s) : Dolutegravir Sodium,Rilpivirine Hydrochloride

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : Not Applicable

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    Lupin Receives Tentative Approval from U.S. FDA for Dolutegravir and Rilpivirine Tablets

    Details : Dolutegravir Sodium, where dolutegravir is an integrase inhibitor while rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) which is used as an oral combination for the treatment of HIV-1 infections in treatment-naive patients.

    Brand Name : Dolutegravir/Rilpivirine-Generic

    Molecule Type : Small molecule

    Upfront Cash : Not Applicable

    January 16, 2023

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    INTERMEDIATES SUPPLIERS

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    01

    Faran Shimi Pharmaceutical

    Iran
    PharmaVenue
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    Virtual BoothFaran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.

    2-(2-Hydroxyphenyl)-4H-1,3-benzoxazin-4-one

    CAS Number : 1218-69-5

    End Use API : Dolutegravir Sodium

    About The Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutica...

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    Virupaksha Organics

    India
    CPhI WW Frankfurt
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    Virtual BoothWith Virupaksha, you get a quality product with on-time delivery.

    (R)-3-amino-1-butanol

    CAS Number : 61477-40-5

    End Use API : Dolutegravir Sodium

    About The Company : Virupaksha Organics, founded in 2003 by G. Chandra Mouliswar Reddy, is committed to delivering products of the utmost quality to its customers. In a span of les...

    Virupaksha

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    Jinan Tantu Chemicals

    China
    CPhI China
    Exhibiting
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    Virtual BoothJinan Tantu Chemicals offers customized R&D services & production of small molecule APIs & pharmaceutical intermediates.

    1-(2,2-diMethoxyethyl)-5-Methoxy-6-(Methoxycarbony...

    CAS Number : 1335210-23-5

    End Use API : Dolutegravir Sodium

    About The Company : Jinan Tantu Chemicals Co., Ltd. operates as a Contract Development and Manufacturing Organization (CDMO) that serves pharmaceutical companies worldwide. Our cor...

    Jinan Tantu Chemicals

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    04

    Laxmi Organic Industries Ltd

    India
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    Virtual BoothLaxmi Organics is a prominent player with a record of building state-of-the-art assets to cater to the needs of a global customer base.

    Methyl 4-chloroacetoacetate

    CAS Number : 32807-28-6

    End Use API : Dolutegravir Sodium

    About The Company : "The Company’s product portfolio includes a wide range of products such as Acetyl Intermediates, Speciality Intermediates, and Fluorine Intermediates. These p... Since its inception, the company has maintained a constant focus on quality, innovation, sustainability, customer centricity which has enabled it to become a reliable partner for its customers." class="partyInfoTitle fa fa-info-circle" aria-hidden="true">

    Laxmi Organic

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    Laxmi Organic Industries Ltd

    India
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    Virtual BoothLaxmi Organics is a prominent player with a record of building state-of-the-art assets to cater to the needs of a global customer base.

    Methyl 4-methoxyacetoacetate

    CAS Number : 41051-15-4

    End Use API : Dolutegravir Sodium

    About The Company : "The Company’s product portfolio includes a wide range of products such as Acetyl Intermediates, Speciality Intermediates, and Fluorine Intermediates. These p... Since its inception, the company has maintained a constant focus on quality, innovation, sustainability, customer centricity which has enabled it to become a reliable partner for its customers." class="partyInfoTitle fa fa-info-circle" aria-hidden="true">

    Laxmi Organic

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    Beijing Mesochem Technology

    China
    PharmaVenue
    Not Confirmed
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    Virtual BoothMesochem is focused on incessant innovation along with the R&D of new APIs.

    (4R,12aS)-3,4,6,8,12,12a-Hexahydro-7-hydroxy-4-met...

    CAS Number : CAS-1246616-73-8

    End Use API : Dolutegravir Sodium

    About The Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutic...

    Mesochem Company Banner

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    07

    Almelo

    India
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    Almelo

    India
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    1-(2,2-Dimethoxyethyl)-5- Methoxy-6- (Methoxycarbo...

    CAS Number : CAS-1335210-23-5

    End Use API : Dolutegravir Sodium

    About The Company : Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse p...

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    Almelo

    India
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    Almelo

    India
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    (4R,12aS)-7-Methoxy-4-Methyl- 6,8-Dioxo-3,4,6,8,12...

    CAS Number : CAS-1335210-34-8

    End Use API : Dolutegravir Sodium

    About The Company : Almelo are the industry leaders in manufacturing advanced intermediates, Active Pharmaceutical Ingredients (APIs) and specialty fine chemicals. With a diverse p...

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    Anupam Rasayan India Ltd.

    India
    PharmaVenue
    Not Confirmed
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    Anupam Rasayan India Ltd.

    India
    PharmaVenue
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    2,4-Difluorobenzylamine

    CAS Number : 72235-52-0

    End Use API : Dolutegravir Sodium

    About The Company : Anupam Rasayan India Limited was started in 1976 and we are 36 years old. ISO 9001:2008 and ISO 14001:2004 certified chemical company with sound technology, en...

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    Guangdong Raffles PharmaTech Co Ltd

    China
    PharmaVenue
    Not Confirmed
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    Guangdong Raffles PharmaTech Co Ltd

    China
    PharmaVenue
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    (4R,12aS)-N-(2,4-Difluorobenzyl)-7-methoxy-4-methy...

    CAS Number : 1335210-35-9

    End Use API : Dolutegravir Sodium

    About The Company : Established in August 2011, Raffles PharmaTech is a high-tech enterprise that focus on development, manufacturing and sales of high-value added active pharmaceu...

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    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Generic

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Gradovir

    Dosage Form : TAB

    Dosage Strength : 50mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

    Aspen API Comapny Banner

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    Aspen Pharmacare Holdings

    South Africa
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    Regulatory Info : Generic

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Vulante

    Dosage Form : FCT

    Dosage Strength : 50mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Strides Pharma Science

    India
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    Virtual BoothStrides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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    Regulatory Info :

    Registration Country : India

    Dolutegravir Sodium

    Brand Name :

    Dosage Form : Tablet

    Dosage Strength : 50MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : India

    Strides Pharma Science

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    Emcure Pharmaceuticals

    India
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    Emcure Pharmaceuticals

    India
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    Regulatory Info :

    Registration Country : USA

    DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Brand Name : DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG/300MG/300MG

    Packaging :

    Approval Date :

    Application Number : 211868

    Regulatory Info :

    Registration Country : USA

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    GSK

    United Kingdom
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    GSK

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    Regulatory Info : Originator

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Tivicay 50mg

    Dosage Form : FCR

    Dosage Strength : 50mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Originator

    Registration Country : South Africa

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    Macleods Pharmaceuticals Limited

    India
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    Regulatory Info :

    Registration Country : USA

    DOLUTEGRAVIR SODIUM

    Brand Name : DOLUTEGRAVIR SODIUM

    Dosage Form : TABLET; ORAL SUSPENSION

    Dosage Strength : 10MG

    Packaging :

    Approval Date :

    Application Number : 214566

    Regulatory Info :

    Registration Country : USA

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    RANBAXY LABORATORIES LIMITED

    India
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    India
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    Regulatory Info : Generic

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Lanograv

    Dosage Form : FCT

    Dosage Strength : 50mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    Shanghai Desano Bio-Pharmaceutical

    China
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    China
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    Regulatory Info :

    Registration Country : USA

    DOLUTEGRAVIR; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

    Brand Name : DOLUTEGRAVIR, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 50MG; 300MG; 300MG

    Packaging :

    Approval Date :

    Application Number : 213556

    Regulatory Info :

    Registration Country : USA

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    Viatris

    U.S.A
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    Regulatory Info : Generic

    Registration Country : South Africa

    Dolutegravir

    Brand Name : Odystra

    Dosage Form : FCT

    Dosage Strength : 50mg

    Packaging : 30X1mg

    Approval Date :

    Application Number :

    Regulatory Info : Generic

    Registration Country : South Africa

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    ViiV Healthcare

    United Kingdom
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    United Kingdom
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    Registration Country : Switzerland

    Dolutegravirum

    Brand Name : Tivicay

    Dosage Form : Filmtabl

    Dosage Strength : 50mg

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    DOSAGE - TABLET;ORAL - EQ 10MG BASE

    USFDA APPLICATION NUMBER - 204790

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    DOSAGE - TABLET;ORAL - EQ 25MG BASE

    USFDA APPLICATION NUMBER - 204790

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    DOSAGE - TABLET;ORAL - EQ 50MG BASE

    USFDA APPLICATION NUMBER - 204790

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

    USFDA APPLICATION NUMBER - 205551

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    ABOUT THIS PAGE

    Dolutegravir Sodium Manufacturers

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

    Dolutegravir Sodium Suppliers

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

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

    Dolutegravir Sodium USDMF

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

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

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

    Dolutegravir Sodium KDMF

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

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

    After submitting a Dolutegravir Sodium 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 Dolutegravir Sodium API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Dolutegravir Sodium suppliers with KDMF on PharmaCompass.

    Dolutegravir Sodium WC

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

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

    Dolutegravir Sodium 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 Dolutegravir Sodium as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Dolutegravir Sodium GMP

    Dolutegravir Sodium 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 Dolutegravir Sodium 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 Dolutegravir Sodium GMP manufacturer or Dolutegravir Sodium GMP API supplier for your needs.

    Dolutegravir Sodium CoA

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

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

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