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Dolutegravir / Rilpivirine

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51 API Suppliers, 25 USDMF, 9 EU WC, 2 KDMF, 12 NDC API, 33 Listed Suppliers, $ API Reference Price

51 API Suppliers
25 USDMF
9 EU WC
2 KDMF
12 NDC API
33 Listed Suppliers
$ API Reference Price

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24 Drugs in Development

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105 FDF Dossiers, 28 FDA Orange Book, 10 Europe, 7 Canada, 1 Australia, 57 South Africa, 2 Listed Dossiers

105 FDF Dossiers
28 FDA Orange Book
10 Europe
7 Canada
1 Australia
57 South Africa
2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE, TABLET;ORAL - EQ 25MG BASE, TABLET;ORAL - EQ 50MG BASE, TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

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TABLET;ORAL - EQ 10MG BASE
TABLET;ORAL - EQ 25MG BASE
TABLET;ORAL - EQ 50MG BASE
TABLET;ORAL - EQ 600MG BASE;EQ 50MG BASE;300MG

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3 US Medicaid Prescriptions, 12 Finished Drug Prices, 32 Annual Reports

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32 Annual Reports

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9 APIs, 8 FDF Dossiers

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5 US Exclusivities
1 Health Canada Patents

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Synopsis

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KDMF

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Listed Suppliers

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$ 435

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38INTERMEDIATES

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105

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

24DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

DIGITAL CONTENT

Data Compilation #PharmaFlow

Stock Recap #PipelineProspector

Weekly News Recap #Phispers

126

News #PharmaBuzz

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68,672

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186 RELATED EXCIPIENT COMPANIES

308EXCIPIENTS BY APPLICATIONS

Chemistry

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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 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 Formula	C₂₀H₁₉F₂N₃O₅
Molecular Weight	419.4 g/mol
XLogP3	2.4
Hydrogen Bond Donor Count	2
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	3
Exact Mass	419.12927704 g/mol
Monoisotopic Mass	419.12927704 g/mol
Topological Polar Surface Area	99.2 Å²
Heavy Atom Count	30
Formal Charge	0
Complexity	829
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	1

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.

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.

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.

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.

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.

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

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.

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).

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.

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.

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.

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). ...

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.

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.

API SUPPLIERS

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USDMF

01

Apitoria Pharma Private Ltd

India

Cosmoprof India

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02

Cipla Ltd

India

Cosmoprof India

Not Confirmed

03

Cipla Ltd

India

Cosmoprof India

Not Confirmed

04

Hetero Labs Ltd

India

Cosmoprof India

Not Confirmed

05

Laurus Labs Ltd

India

China

Cosmoprof India

Not Confirmed

10

Tianish Laboratories Private Ltd

U.S.A

Cosmoprof India

Not Confirmed

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EU WC

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KDMF

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NDC API

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Listed Suppliers

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API Reference Price

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LTD","customerCountry":"INDIA","quantity":"99.08","actualQuantity":"99.08","unit":"KGS","unitRateFc":"245","totalValueFC":"24568.3","currency":"USD","unitRateINR":"20237","date":"30-Nov-2022","totalValueINR":"2005081.96","totalValueInUsd":"24568.3","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"3534348","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"304,ATLANTA ARCADE, MAROL CHURCH RD,ANDHERI EAST Contac"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1670351400,"product":"DOLUTEGRAVIR SODIUM","address":"304,ATLANTA ARCADE, MAROL CHURCH RD,ANDHERI EAST Contac","city":"MUMBAI","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"MACLEODS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"1526.58","actualQuantity":"1526.58","unit":"KGS","unitRateFc":"245","totalValueFC":"372168.2","currency":"USD","unitRateINR":"20090","date":"07-Dec-2022","totalValueINR":"30668992.2","totalValueInUsd":"372168.2","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"3637680","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"304,ATLANTA ARCADE, MAROL CHURCH RD,ANDHERI EAST Contac"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1671042600,"product":"DOLUTEGRAVIR SODIUM","address":"304,ATLANTA ARCADE, MAROL CHURCH RD,ANDHERI EAST Contac","city":"MUMBAI","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"MACLEODS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"99.08","actualQuantity":"99.08","unit":"KGS","unitRateFc":"245","totalValueFC":"24154.9","currency":"USD","unitRateINR":"20090","date":"15-Dec-2022","totalValueINR":"1990517.2","totalValueInUsd":"24154.9","indian_port":"BOMBAY AIR","hs_no":"29349990","bill_no":"3750846","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"304,ATLANTA ARCADE, MAROL CHURCH RD,ANDHERI EAST Contac"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1674412200,"product":"DOLUTEGRAVIR SODIUM","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER","city":"PAREL MUMBAI MAHARASHTRA,MAHARASHTR","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"1810.00","actualQuantity":"1810","unit":"KGS","unitRateFc":"250","totalValueFC":"455491.6","currency":"USD","unitRateINR":"20575","date":"23-Jan-2023","totalValueINR":"37240750","totalValueInUsd":"455491.6","indian_port":"JNPT","hs_no":"29349990","bill_no":"4317904","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691001000,"product":"DOLUTEGRAVIR DOLUTEGRAVIR SODIUM","address":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER PAREL","city":"MUMBAI","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"NA","customer":"CIPLA","customerCountry":"INDIA","quantity":"1950.00","actualQuantity":"1950","unit":"KGS","unitRateFc":"225","totalValueFC":"442706.4","currency":"USD","unitRateINR":"18618.2","date":"03-Aug-2023","totalValueINR":"36672164.1","totalValueInUsd":"442706.4","indian_port":"JNPT\/ NHAVA SHEVA SEA","hs_no":"29349990","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"CIPLA HOUSE, PENINSULA BUSINESS,PA RK,GANPATRAO KADAM MARG,LOWER PAREL"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1694975400,"product":"DOLUTEGRAVIR SODIUM","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"250.00","actualQuantity":"250","unit":"KGS","unitRateFc":"225","totalValueFC":"56888.2","currency":"USD","unitRateINR":"18888.8","date":"18-Sep-2023","totalValueINR":"4722188","totalValueInUsd":"56888.2","indian_port":"Indore-EPZ\/SEZ","hs_no":"29349990","bill_no":"1006188","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.1479, ZHANGHENG ROAD ZHAMGJIANG HI-TECH PARK CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695407400,"product":"DOLUTEGRAVIR SODIUM","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"NANNING","customer":"CIPLA","customerCountry":"INDIA","quantity":"459.41","actualQuantity":"459.41","unit":"KGS","unitRateFc":"220","totalValueFC":"103381.5","currency":"USD","unitRateINR":"18679.4","date":"23-Sep-2023","totalValueINR":"8581513.23","totalValueInUsd":"103381.5","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"7974749","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANNING","supplierAddress":"ADD: NO. 1479 ZHANGHENG ROAD,ZHANGJIANG HI-TECH PARK,SHANGHAI CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695580200,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"145.00","actualQuantity":"145","unit":"KGS","unitRateFc":"220","totalValueFC":"32300.4","currency":"USD","unitRateINR":"18491","date":"25-Sep-2023","totalValueINR":"2681195","totalValueInUsd":"32300.4","indian_port":"JNPT","hs_no":"29349990","bill_no":"7998525","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695580200,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"499.00","actualQuantity":"499","unit":"KGS","unitRateFc":"220","totalValueFC":"111157.8","currency":"USD","unitRateINR":"18491","date":"25-Sep-2023","totalValueINR":"9227009","totalValueInUsd":"111157.8","indian_port":"JNPT","hs_no":"29349990","bill_no":"7998525","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1695580200,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"1097.53","actualQuantity":"1097.53","unit":"KGS","unitRateFc":"220","totalValueFC":"244487","currency":"USD","unitRateINR":"18491","date":"25-Sep-2023","totalValueINR":"20294427.23","totalValueInUsd":"244487","indian_port":"JNPT","hs_no":"29349990","bill_no":"7998525","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696530600,"product":"DOLUTEGRAVIR SODIUM","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"NANNING","customer":"CIPLA","customerCountry":"INDIA","quantity":"1199.06","actualQuantity":"1199.06","unit":"KGS","unitRateFc":"220","totalValueFC":"269787.9","currency":"USD","unitRateINR":"18726.6","date":"06-Oct-2023","totalValueINR":"22454256.91","totalValueInUsd":"269787.9","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"8168720","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"NANNING","supplierAddress":"ADD: NO. 1479 ZHANGHENG ROAD,ZHANGJIANG HI-TECH PARK,SHANGHAI CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1696962600,"product":"DOLUTEGRAVIR SODIUM","address":"304,ATLANTA ARCADE,","city":"MUMBAI MAHARASHTRA","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"MACLEODS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"2000.00","actualQuantity":"2000","unit":"KGS","unitRateFc":"215","totalValueFC":"434756.8","currency":"USD","unitRateINR":"18092.3","date":"11-Oct-2023","totalValueINR":"36184500","totalValueInUsd":"434756.8","indian_port":"JNPT","hs_no":"29349990","bill_no":"8252879","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.1479 ZHANGHENG ROAD,ZHANGJING HI TECH PARK,SHANGHAI CHINA","customerAddress":"304,ATLANTA ARCADE,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1697653800,"product":"DOLUTEGRAVIR SODIUM","address":"304,ATLANTA ARCADE,","city":"MUMBAI MAHARASHTRA","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"MACLEODS PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"1380.00","actualQuantity":"1380","unit":"KGS","unitRateFc":"215","totalValueFC":"299982.2","currency":"USD","unitRateINR":"18092.3","date":"19-Oct-2023","totalValueINR":"24967305","totalValueInUsd":"299982.2","indian_port":"JNPT","hs_no":"29349990","bill_no":"8380697","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.1479 ZHANGHENG ROAD,ZHANGJING HI TECH PARK,SHANGHAI CHINA","customerAddress":"304,ATLANTA ARCADE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713205800,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"920.00","actualQuantity":"920","unit":"KGS","unitRateFc":"200","totalValueFC":"185856.8","currency":"USD","unitRateINR":"16870","date":"16-Apr-2024","totalValueINR":"15520400","totalValueInUsd":"185856.8","indian_port":"JNPT","hs_no":"29349990","bill_no":"3051277","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1713205800,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"1180.00","actualQuantity":"1180","unit":"KGS","unitRateFc":"200","totalValueFC":"238381.5","currency":"USD","unitRateINR":"16870","date":"16-Apr-2024","totalValueINR":"19906600","totalValueInUsd":"238381.5","indian_port":"JNPT","hs_no":"29349990","bill_no":"3051277","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716402600,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"1403.00","actualQuantity":"1403","unit":"KGS","unitRateFc":"200","totalValueFC":"283952.3","currency":"USD","unitRateINR":"16870","date":"23-May-2024","totalValueINR":"23668610","totalValueInUsd":"283952.3","indian_port":"JNPT","hs_no":"29349990","bill_no":"3621771","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1716402600,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"2028.57","actualQuantity":"2028.57","unit":"KGS","unitRateFc":"200","totalValueFC":"410561","currency":"USD","unitRateINR":"16870","date":"23-May-2024","totalValueINR":"34221975.9","totalValueInUsd":"410561","indian_port":"JNPT","hs_no":"29349990","bill_no":"3621771","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722105000,"product":"DOLUTEGRAVIR (DOLUTEGRAVIR SODIUM)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"DESANO LIMITED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"CIPLA","customerCountry":"INDIA","quantity":"3617.00","actualQuantity":"3617","unit":"KGS","unitRateFc":"200","totalValueFC":"731698.6","currency":"USD","unitRateINR":"16910","date":"28-Jul-2024","totalValueINR":"61163470","totalValueInUsd":"731698.6","indian_port":"JNPT","hs_no":"29349990","bill_no":"4749482","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"1479 ZHANGHENG ROAD ZHANG JIANG HI-TECH PARK SHANGHAISDNF China","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q4","strtotime":1729103400,"product":"DOLUTEGRAVIR SODIUM IH","address":"HETERO CORPORATE, NO. 7-2-A2,,INDU","city":"HYDERABAD,TELANGANA","supplier":"HETERO LABS LTD UNIT IX","supplierCountry":"INDIA","foreign_port":"HIPL SEZ","customer":"HETERO DRUGS","customerCountry":"INDIA","quantity":"195.00","actualQuantity":"195","unit":"KGS","unitRateFc":"206.2","totalValueFC":"40612.2","currency":"USD","unitRateINR":"17500","date":"17-Oct-2024","totalValueINR":"3412500","totalValueInUsd":"40612.2","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":"PLOT-NO.2,HETEROINFRASTRUCTURE SEZ AKKAPALLI(MANDAL)ANAKAPALLIDISTRICT SDNF India","customerAddress":"HETERO CORPORATE, NO. 7-2-A2,,INDU"}]

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

INTERMEDIATES SUPPLIERS

01

Faran Shimi Pharmaceutical

Iran

Antibody Engineering

Not Confirmed

Faran 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

Product Web Link

Corporate PDF

02

Virupaksha Organics

India

CPhI WW Frankfurt

Booth #11.0F34

With 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

03

Jinan Tantu Chemicals

China

CPhI China

Exhibiting

Jinan 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

Product Web Link

04

Laxmi Organic Industries Ltd

India

Antibody Engineering

Not Confirmed

Laxmi 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

Product Web Link

Corporate PDF

05

Laxmi Organic Industries Ltd

India

Antibody Engineering

Not Confirmed

Laxmi 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

Portfolio PDF

Product Web Link

Virtual Booth

China

Antibody Engineering

Not Confirmed

Only 10 entries up to this point, click to access all

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FDF Dossiers

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FDA Orange Book

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Europe

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Canada

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Australia

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South Africa

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Listed Dossiers

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DRUG PRODUCT COMPOSITIONS

Do you need Business Intel? Ask us

DOSAGE - TABLET;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 204790

DOSAGE - TABLET;ORAL - EQ 25MG BASE

USFDA APPLICATION NUMBER - 204790

DOSAGE - TABLET;ORAL - EQ 50MG BASE

USFDA APPLICATION NUMBER - 204790

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

USFDA APPLICATION NUMBER - 205551

Related Excipient Companies

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Excipients by Applications

Click here to find the perfect excipient manufacturers by their capabilities

Fillers, Diluents & Binders

01

Rochem International Inc

U.S.A

Suppliers Night Expo

Attending

Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannitol

Application : Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannitol is used as a filler, bulking agent and taste masking agent in ODT formulations such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

02

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Orodispersible Tablet, Tablet

Grade : Oral

Category : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Pharmaburst 500

Application : Chewable & Orodispersible Aids, Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Pharmaburst® 500 is a directly compressible pharmaceutical excipient used to create orally disintegrating tablets quickly and easily.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

03

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Tablet

Grade : Oral

Category : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Brand Name : Mannogem® XL Opal

Application : Direct Compression, Fillers, Diluents & Binders, Taste Masking

Excipient Details : Mannogem® XL Opal, directly compressible 160 µm spray-dried mannitol provides superior binding properties and tabletability.

Pharmacopoeia Ref : NA

Technical Specs : 160 µm Powder Mannitol

Ingredient(s) : Mannitol

04

Faran Shimi Pharmaceutical

Iran

Pharma, Lab & Chemical Expo

Not Confirmed

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

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Lactose Monohydrate

Application : Fillers, Diluents & Binders

Excipient Details : Lactose monohydrate is widely used as a filler and diluent in solid dosage forms such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

05

Faran Shimi Pharmaceutical

Iran

Pharma, Lab & Chemical Expo

Not Confirmed

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

Dosage Form : Tablet

Grade : Oral

Category : Fillers, Diluents & Binders

Brand Name : Polyvinylpyrrolidone

Application : Fillers, Diluents & Binders

Excipient Details : Polyvinylpyrrolidone is used as a low viscosity wet binder in solid dosage forms such as tablets.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Polyvinylpyrrolidone

06

Boai NKY Pharmaceuticals Ltd

China

Pharma, Lab & Chemical Expo

Not Confirmed

Boai NKY Pharmaceuticals Ltd. is one of the largest global PVP suppliers.

Dosage Form : Capsule, Tablet

Grade : Oral (Pharma Grade)

Category : Fillers, Diluents & Binders

Brand Name : KoVidone® K25

Application : Fillers, Diluents & Binders

Excipient Details : KoVidone® K25 is used as a low viscosity wet binder in solid dosage forms such as capsules and tablets.

Pharmacopoeia Ref : USP/NF, EP, JP, KP, IP, BP

Technical Specs : NA

Ingredient(s) : Polyvinylpyrrolidone

07

Gangwal Healthcare

India

Pharma, Lab & Chemical Expo

Not Confirmed

Gangwal Healthcare is powered by innovation, driving health, wellness & healing.

Dosage Form : Capsule, Tablet

Grade : Oral

Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Brand Name : STARLOSE®

Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders

Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.

Pharmacopoeia Ref : IP/EP/USP-NF/IH

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

08

Nanjing Well Pharmaceutical

China

Pharma, Lab & Chemical Expo

Not Confirmed

Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.

Dosage Form : Injectable / Parenteral

Grade : Parenteral

Category : Parenteral

Brand Name : Lactose Monohydrate

Application : Parenteral

Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.

Pharmacopoeia Ref : ChP/USP/EP/JP

Technical Specs : NA

Ingredient(s) : Lactose Monohydrate

09

Pfanstiehl

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.

Dosage Form : Injectable / Parenteral, Tablet

Grade : Parenteral, Oral

Category : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

Brand Name : D-Mannitol

Application : Fillers, Diluents & Binders, Parenteral, Thickeners and Stabilizers

Excipient Details : D-mannitol protects proteins from denaturation & degradation. It is also used as a stabilizer in liquid formulations & as a bulking agent in tablets.

Pharmacopoeia Ref : USP, NF, EP, JP, ChP

Technical Specs : N/A

Ingredient(s) : Mannitol

10

Faran Shimi Pharmaceutical

Iran

Pharma, Lab & Chemical Expo

Not Confirmed

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

Dosage Form : Tablet

Grade : Oral

Category : Co-Processed Excipients

Brand Name : Mannitol

Application : Co-Processed Excipients

Excipient Details : Mannitol is a co-processed excipient with superior compactibility, lower disintegration time, and hygroscopicity.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Only 10 entries up to this point, click to access all

Direct Compression

Coating Systems & Additives

Granulation

01

SPI Pharma

U.S.A

Pharma, Lab & Chemical Expo

Not Confirmed

SPI Pharma has been solving formulation challenges using superior functional materials.

Dosage Form : Granule / Pellet, Tablet

Grade : Oral

Category : Fillers, Diluents & Binders, Granulation

Brand Name : Mannogem Powder

Application : Fillers, Diluents & Binders, Granulation

Excipient Details : Mannogem (mannitol powder) is a pharmaceutical excipient that dissolves rapidly and increases tablet disintegration rate, drug dissolution & release.

Pharmacopoeia Ref : NA

Technical Specs : NA

Ingredient(s) : Mannitol

Excipients Web Link

Austria

Pharma, Lab & Chemical Expo

Not Confirmed

Only 10 entries up to this point, click to access all

Lubricants & Glidants

Disintegrants & Superdisintegrants

Thickeners and Stabilizers

Co-Processed Excipients

Controlled & Modified Release

Solubilizers

Chewable & Orodispersible Aids

Parenteral

Taste Masking

Topical

Film Formers & Plasticizers

API Stability Enhancers

Coloring Agents

Surfactant & Foaming Agents

Rheology Modifiers

Emulsifying Agents

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Market Place

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ACCESS ALL DATA

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

51 API Suppliers

25 USDMF

9 EU WC

2 KDMF

12 NDC API

33 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

24 Drugs in Development

INTERMEDIATES

38 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

105 FDF Dossiers

28 FDA Orange Book

10 Europe

7 Canada

1 Australia

57 South Africa

2 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 10MG BASE

TABLET;ORAL - EQ 25MG BASE

TABLET;ORAL - EQ 50MG BASE

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

RELATED EXCIPIENT COMPANIES

1 Minakem

1 Rochem International Inc

14 SPI Pharma

2 Seqens

3 DKSH

5 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

11 Gangwal Healthcare

2 Nanjing Well Pharmaceutical

1 Pfanstiehl

3 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

20 BASF

5 Corel Pharma Chem

5 DFE Pharma

1 Finar

7 Gangwal Chemicals

3 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

22 Kerry

12 Microlex e.U

1 NEWEDGE Overseas

2 Nomisma Healthcare

2 Novo Excipients

3 Pharmatrans-Sanaq

5 Pluviaendo

4 Prachin Chemical

13 Roquette

2 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

11 Sigachi Industries

1 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

67 Fillers, Diluents & Binders

32 Direct Compression

22 Coating Systems & Additives

19 Granulation

19 Lubricants & Glidants

19 Disintegrants & Superdisintegrants

18 Thickeners and Stabilizers

18 Co-Processed Excipients

16 Controlled & Modified Release

15 Solubilizers