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    Also known as: Abt-493, Glecaprevir [usan], 1365970-03-1, A-1282576.0, K6buu8j72p, A-1282576
    Molecular Formula
    C38H46F4N6O9S
    Molecular Weight
    838.9  g/mol
    InChI Key
    MLSQGNCUYAMAHD-ITNVBOSISA-N
    FDA UNII
    K6BUU8J72P
    Glecaprevir
    Glecaprevir is a direct acting antiviral agent and Hepatitis C virus (HCV) NS3/4A protease inhibitor that targets the the viral RNA replication. In combination with [DB13878], glecaprevir is a useful therapy for patients who experienced therapeutic failure from other NS3/4A protease inhibitors. It demonstrates a high genetic barrier against resistance mutations of the virus. In cell cultures, the emergence of amino acid substitutions at NS3 resistance-associated positions A156 or D/Q168 in HCV genotype 1a, 2a or 3a replicons led to reduced susceptibility to glecaprevir. The combinations of amino acid substitutions at NS3 position Y65H and D/Q168 also results in greater reductions in glecaprevir susceptibility, and NS3 Q80R in genotype 3a patients also leads to glecaprevir resistance. Glecaprevir is available as an oral combination therapy with [DB13878] under the brand name Mavyret. This fixed-dose combination therapy was FDA-approved in August 2017 to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also indicated for HCV genotype 1-infected patients who have been previously treated with regimens either containing an NS5A inhibitor or an NS3/4A protease inhibitor, but not both. Hepatitis C viral infection often leads to decreased liver function and subsequent liver failure, causing a significantly negative impact on the patients' quality of life. The ultimate goal of the combination treatment is to achieve sustained virologic response (SVR) and cure the patients from the infection. In clinical trials, this combination therapy achieved SVR12 rate, or undetectable Hepatitis C for twelve or more weeks after the end of treatment, of 93% across genotypes 1a, 2a, 3a, 4, 5 and 6.
    Glecaprevir is a Hepatitis C Virus NS3/4A Protease Inhibitor. The mechanism of action of glecaprevir is as a HCV NS3/4A Protease Inhibitor, and P-Glycoprotein Inhibitor, and Breast Cancer Resistance Protein Inhibitor, and Organic Anion Transporting Polypeptide 1B1 Inhibitor, and Organic Anion Transporting Polypeptide 1B3 Inhibitor, and Cytochrome P450 3A Inhibitor, and Cytochrome P450 1A2 Inhibitor, and UGT1A1 Inhibitor.
    1 2D Structure

    Glecaprevir

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (1R,14E,18R,22R,26S,29S)-26-tert-butyl-N-[(1R,2R)-2-(difluoromethyl)-1-[(1-methylcyclopropyl)sulfonylcarbamoyl]cyclopropyl]-13,13-difluoro-24,27-dioxo-2,17,23-trioxa-4,11,25,28-tetrazapentacyclo[26.2.1.03,12.05,10.018,22]hentriaconta-3,5,7,9,11,14-hexaene-29-carboxamide
    2.1.2 InChI
    InChI=1S/C38H46F4N6O9S/c1-35(2,3)28-32(50)48-19-20(17-24(48)30(49)46-37(18-21(37)29(39)40)33(51)47-58(53,54)36(4)14-15-36)56-31-27(43-22-9-5-6-10-23(22)44-31)38(41,42)13-8-16-55-25-11-7-12-26(25)57-34(52)45-28/h5-6,8-10,13,20-21,24-26,28-29H,7,11-12,14-19H2,1-4H3,(H,45,52)(H,46,49)(H,47,51)/b13-8+/t20-,21+,24+,25-,26-,28-,37-/m1/s1
    2.1.3 InChI Key
    MLSQGNCUYAMAHD-ITNVBOSISA-N
    2.1.4 Canonical SMILES
    CC1(CC1)S(=O)(=O)NC(=O)C2(CC2C(F)F)NC(=O)C3CC4CN3C(=O)C(NC(=O)OC5CCCC5OCC=CC(C6=NC7=CC=CC=C7N=C6O4)(F)F)C(C)(C)C
    2.1.5 Isomeric SMILES
    CC1(CC1)S(=O)(=O)NC(=O)[C@]2(C[C@H]2C(F)F)NC(=O)[C@@H]3C[C@@H]4CN3C(=O)[C@@H](NC(=O)O[C@@H]5CCC[C@H]5OC/C=C/C(C6=NC7=CC=CC=C7N=C6O4)(F)F)C(C)(C)C
    2.2 Other Identifiers
    2.2.1 UNII
    K6BUU8J72P
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Abt-493

    2.3.2 Depositor-Supplied Synonyms

    1. Abt-493

    2. Glecaprevir [usan]

    3. 1365970-03-1

    4. A-1282576.0

    5. K6buu8j72p

    6. A-1282576

    7. A-12825760

    8. 1365970-03-1 (free)

    9. Abt 493

    10. (3ar,7s,10s,12r,21e,24ar)-7-tert-butyl-n-[(1r,2r)-2-(difluoromethyl)-1-{[(1-methylcyclopropyl)sulfonyl]carbamoyl}cyclopropyl]-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1h,10h-9,12-methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide

    11. (3ar,7s,10s,12r,21e,24ar)-7-tert-butyl-n-{(1r,2r)-2(difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1h,10h-9,12methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10carboxamide

    12. Unii-k6buu8j72p

    13. Maviret

    14. (3ar,7s,10s,12r,21e,24ar)-7-tert-butyl-n-[(1r,2r)-2-(difluoromethyl)-1-{[(1-methylcyclopropyl)sulfonyl]carbamoyl}cyclop Ropyl]-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1h,10h-9,12-methanocyclopenta[18,19][1,10,17, 3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide

    15. O31

    16. Glecaprevir [mi]

    17. Abt-493(glecaprevir)

    18. Glecaprevir [inn]

    19. Glecaprevir (usan/inn)

    20. Glecaprevir [who-dd]

    21. Schembl883097

    22. Abt493

    23. Chembl3545363

    24. Gtpl11267

    25. Glecaprevir [orange Book]

    26. Dtxsid901027945

    27. (1r,14e,18r,22r,26s,29s)-26-tert-butyl-n-[(1r,2r)-2-(difluoromethyl)-1-[(1-methylcyclopropyl)sulfonylcarbamoyl]cyclopropyl]-13,13-difluoro-24,27-dioxo-2,17,23-trioxa-4,11,25,28-tetrazapentacyclo[26.2.1.03,12.05,10.018,22]hentriaconta-3,5,7,9,11,14-hexaene-29-carboxamide

    28. Amy38157

    29. Ex-a1940

    30. Mavyret Component Glecaprevir

    31. Bdbm50573891

    32. S5720

    33. Cs-8098

    34. Db13879

    35. Ac-33419

    36. Hy-17634

    37. J3.646.120i

    38. D10814

    39. 3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10-carboxamide

    40. (3ar,7s,10s,12r,21e,24ar)-7-tert-butyl-n-((1r,2r)-2-(difluoromethyl)-1-((1-methylcyclopropane-1-sulfonyl)carbamoyl)cyclopropyl)-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1h,10h-9,12-methanocyclopenta(18,19)(1,10,17,3,6)trioxadiazacyclononadecino(11,12-b)quinoxaline-10-carboxamide

    41. (3ar,7s,10s,12r,21e,24ar)-7-tert-butyl-n-[(1r,2r)-2-(difluoromethyl)-1-{[(1-methylcyclopropyl)sulfonyl]carbamoyl}cyclop

    42. (3ar,7s,10s,12r,21e,24ar)-7-tert-butyl-n-{(1r,2r)-2- (difluoromethyl)-1-[(1-methylcyclopropane-1-sulfonyl)carbamoyl]cyclopropyl}-20,20-difluoro- 5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1h,10h-9,12- Methanocyclopenta[18,19][1,10,17,3,6]trioxadiazacyclononadecino[11,12-b]quinoxaline-10- Carboxamide Hydrate

    43. Cyclopropanecarboxamide, N-((((1r,2r)-2-((4,4-difluoro-4-(3-hydroxy-2-quinoxalinyl)-2-buten-1-yl)oxy)cyclopentyl)oxy)carbonyl)-3-methyl-l-valyl-(4r)-4-hydroxy-l-prolyl-1-amino-2-(difluoromethyl)-n-((1-methylcyclopropyl)sulfonyl)-, Cyclic (1->2)-ether, (1r,2r)-

    44. Ropyl]-20,20-difluoro-5,8-dioxo-2,3,3a,5,6,7,8,11,12,20,23,24a-dodecahydro-1h,10h-9,12-methanocyclopenta[18,19][1,10,17,

    2.4 Create Date
    2012-11-30
    3 Chemical and Physical Properties
    Molecular Weight 838.9 g/mol
    Molecular Formula C38H46F4N6O9S
    XLogP34.6
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count15
    Rotatable Bond Count7
    Exact Mass838.29831089 g/mol
    Monoisotopic Mass838.29831089 g/mol
    Topological Polar Surface Area204 Ų
    Heavy Atom Count58
    Formal Charge0
    Complexity1760
    Isotope Atom Count0
    Defined Atom Stereocenter Count7
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    Indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A). MAVYRET is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

    FDA Label

    Maviret is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults and children aged 3 years and older.

    Maviret coated granules is indicated for the treatment of chronic hepatitis C virus (HCV) infection in children 3 years and older.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    In a biochemical assay studying clinical isolates of HCV genotypes 1a, 1b, 2a, 2b, 3a, 4a, 5a, and 6a, glecaprevir displayed IC50 values ranging from 3.5 to 11.3 nM that resulted in inhibition of the proteolytic activity of recombinant NS3/4A enzymes. In HCV replicon assays, glecaprevir had median EC50 values of 0.08-4.6 nM against laboratory and clinical isolates from subtypes 1a, 1b, 2a, 2b, 3a, 4a, 4d, 5a, and 6a. In a QT study, glecaprevir is not shown to prolong the QTc interval.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    GLECAPREVIR
    5.2.2 FDA UNII
    K6BUU8J72P
    5.2.3 Pharmacological Classes
    Mechanisms of Action [MoA] - UGT1A1 Inhibitors
    5.3 ATC Code

    J05AP57

    5.4 Absorption, Distribution and Excretion

    Absorption

    In healthy subjects, the time it takes to reach the peak plasma concentration (Tmax) is approximately 5 hours. The mean peak plasma concentration (Cmax) is 597ng/mL in non-cirrhotic HCV-infected subjects. Relative to fasting conditions, the consumption of meals increases the absorption of glecaprevir by 83-163%.

    Route of Elimination

    The predominant route of elimination of the drug is biliary-fecal, where 92.1% of administered drug is excreted in feces and 0.7% of the drug is excreted in the urine.

    5.5 Metabolism/Metabolites

    Glecaprevir undergoes limited secondary metabolism in vitro, predominantly by CYP3A.

    5.6 Biological Half-Life

    The elimination half life (t1/2) is approximately 6 hours.

    5.7 Mechanism of Action

    Glecaprevir is an inhibitor of the HCV NS3/4A protease, which is a viral enzyme necessary for the proteolytic cleavage of the HCV encoded polyprotein into mature forms of the NS3, NS4A, NS4B, NS5A, and NS5B proteins. These multifunctional proteins, including NS3, are essential for viral replication. The N-terminal of NS3 protein confers serine protease activity, whileThe C-terminus of NS3 encodes a DExH/D-box RNA helicase which hydyolyzes NTP as an energy source to unwind double-stranded RNA in a 3 to 5 direction during replication of viral genomic RNA. NS4A is a cofactor for NS3 that directs the localization of NS3 and modulates its enzymatic activities. Glecaprevir disrupts the intracellular processes of the viral life cycle through inhibiting the NS3/4A protease activity of cleaving downstream junctions of HCV polypeptide and proteolytic processing of mature structural proteins.

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    Enanta Pharmaceuticals Announces Sale of a Portion of Global Royalties on MAVYRET® (U.S.)/MAVIRET® (ex-U.S.) (Glecaprevir/Pibrentasvir) to OMERS Life ...

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    Through the divestment, Enanta will sale a Portion of Global Royalties on MAVYRET® (U.S.)/MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir) to OMERS Life Sciences. The net sale proceeds will be used to fund the continuing clinical development of virology pipeline.


    Lead Product(s): Glecaprevir,Pibrentasvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Mavyret

    Study Phase: ApprovedProduct Type: Small molecule

    Sponsor: OMERS Life Sciences

    Deal Size: $200.0 million Upfront Cash: Undisclosed

    Deal Type: Divestment April 25, 2023

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    Lead Product(s) : Glecaprevir,Pibrentasvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved

    Partner/Sponsor/Collaborator : OMERS Life Sciences

    Deal Size : $200.0 million

    Deal Type : Divestment

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    Enanta Pharmaceuticals Announces Sale of a Portion of Global Royalties on MAVYRET® (U.S.)/MAVIRET...

    Details : Through the divestment, Enanta will sale a Portion of Global Royalties on MAVYRET® (U.S.)/MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir) to OMERS Life Sciences. The net sale proceeds will be used to fund the continuing clinical development of virology p...

    Brand Name : Mavyret

    Molecule Type : Small molecule

    Upfront Cash : Undisclosed

    April 25, 2023

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    1-Methyl cyclopropyl-1-sulfonamide

    CAS Number : 669008-26-8

    End Use API : Glecaprevir

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    Cyclopropyl Sulfonamide

    CAS Number : 154350-29-5

    End Use API : Glecaprevir

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    L-tert-Leucine

    CAS Number : 20859-02-3

    End Use API : Glecaprevir

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    N-(tert-butyl)-3-chloropropane-1-sulfonamide

    CAS Number : 63132-85-4

    End Use API : Glecaprevir

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    Guangdong Raffles PharmaTech Co Ltd

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    N-tert-butylcyclopropanesulfonamide

    CAS Number : 630421-42-0

    End Use API : Glecaprevir

    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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    Cyclopropanesulfonamide

    CAS Number : 154350-29-5

    End Use API : Glecaprevir

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    Guangdong Raffles PharmaTech Co Ltd

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    1-Methylcyclopropanesulfonamide

    CAS Number : 669008-26-8

    End Use API : Glecaprevir

    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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    (1R,2R)-1-amino-2-(difluoromethyl)-N-((1-methylcyc...

    CAS Number : 1360997-58-5

    End Use API : Glecaprevir

    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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    Guangdong Raffles PharmaTech Co Ltd

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    (1R,2R)-1-amino-2-(difluoromethyl)-N-((1-methylcyc...

    CAS Number : 1360828-80-3

    End Use API : Glecaprevir

    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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    3-(1,1 -difluoroallyl)quinoxalin-2-ol

    CAS Number : 1294512-27-8

    End Use API : Glecaprevir

    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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    Regulatory Info : RX

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    GLECAPREVIR; PIBRENTASVIR

    Brand Name : MAVYRET

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG;40MG

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    Approval Date : 2017-08-03

    Application Number : 209394

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    Regulatory Info : RX

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    Approval Date : 2021-06-10

    Application Number : 215110

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    Glecaprevirum; Pibrentasvirus

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    Regulatory Info :

    Registration Country : Canada

    GLECAPREVIR

    Brand Name : MAVIRET

    Dosage Form : TABLET

    Dosage Strength : 100MG

    Packaging : 21/84

    Approval Date :

    Application Number : 2467550

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    Regulatory Info :

    Registration Country : Canada

    GLECAPREVIR

    Brand Name : MAVIRET

    Dosage Form : GRANULES

    Dosage Strength : 50MG/SACHET

    Packaging :

    Approval Date :

    Application Number : 2522470

    Regulatory Info :

    Registration Country : Canada

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    RLD : Yes

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    GLECAPREVIR; PIBRENTASVIR

    Brand Name : MAVYRET

    Dosage Form : TABLET;ORAL

    Dosage Strength : 100MG;40MG

    Approval Date : 2017-08-03

    Application Number : 209394

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    RLD : Yes

    TE Code :

    GLECAPREVIR; PIBRENTASVIR

    Brand Name : MAVYRET

    Dosage Form : PELLETS;ORAL

    Dosage Strength : 50MG;20MG/PACKET

    Approval Date : 2021-06-10

    Application Number : 215110

    RX/OTC/DISCN : RX

    RLD : Yes

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    Regulatory Info :

    Registration Country : Switzerland

    Glecaprevirum; Pibrentasvirus

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    Glecaprevir; Pibrentasvir

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    Glecaprevir

    Main Therapeutic Indication : Infectious Diseases

    Currency : USD

    2020 Revenue in Millions : 1,830

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    Glecaprevir

    Main Therapeutic Indication : Infectious Diseases

    Currency : USD

    2021 Revenue in Millions : 1,710

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    Main Therapeutic Indication : Infectious Diseases

    Currency : USD

    2022 Revenue in Millions : 1,541

    2021 Revenue in Millions : 1,710

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    Main Therapeutic Indication : Infectious Diseases

    Currency : USD

    2023 Revenue in Millions : 1,430

    2022 Revenue in Millions : 1,541

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    Glecaprevir/Pibrentasvir

    Main Therapeutic Indication : Infectious Diseases (HIV, Hepatitis...

    Currency : USD

    2018 Revenue in Millions : 3,438

    2017 Revenue in Millions : 0

    Growth (%) : New Launch

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    Glecaprevir

    Main Therapeutic Indication : Infectious Diseases

    Currency : USD

    2019 Revenue in Millions : 2,893

    2018 Revenue in Millions : 3,438

    Growth (%) : -16

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    Pakistan.png
    Tapentadol, Voxilaprevir, Dexrabeprazole and other APIs needed in Pakistan [ENA02192]
    Crystal Chemicals, a leading indenting house in Pakistan is looking manufacturers/suppliers of following APIs with GMP, DMF and COA: 1. Tapentadol 2. Voxilaprevir 3. Terlipressin 4. Dexrabeprazole 5. Glecaprevir 6. Pibrentasvir 7. Delafloxacin Interested suppliers should contact at Email: import@crystalchemicals.com.pk or Phone: 923218484135.
    07 Oct 2018

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    07 Oct 2018

    Pakistan.png
    Glecaprevir and other APIs needed in Pakistan [ENA02160]
    One of the leading business groups in Pakistan is looking for suppliers/manufacturers of the following APIs: 1) Glecaprevir 2) Pibrentasvir 3) Velpatasvir Interested suppliers must support this enquiry with the following specifications: 1) Certificate of Analysis (COA) 2) A valid GMP certificate 3) MSDS 4) FDA The suppliers must contact Chetan Jolla via E-mail: cjolla@arfeengroup.com or Tel: 00922135872160/62.
    02 Oct 2018

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    02 Oct 2018

    Market Place
    Enquiry// Glecaprevir (1kg), Pibrentasvir (1kg) and Valbenazine (1kg) needed in Bangladesh [ENA01410]
    Amity trading company ensures you quality, reliability and continuous innovation thereby enhancing the sustainability & value of all partners, is looking for the suppliers of Glecaprevir (1kg), Pibrentasvir (1kg) and Valbenazine (1kg). Interested suppliers must support this enquiry with COA and GMP status and can contact G.M. Khalilur Rahman via E-mail: amity@amity-tc.com or Tel: +880 1912857404/ +880 1711267758 .
    09 Aug 2018

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    09 Aug 2018

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    US Patents

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    ABBVIE

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    Pharmatech Expo 2025
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    Patent Expiration Date : 2032-07-19

    GLECAPREVIR; PIBRENTASVIR

    US Patent Number : 8648037*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 215110

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2032-07-19

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    Patent Expiration Date : 2032-01-19

    GLECAPREVIR; PIBRENTASVIR

    US Patent Number : 8648037

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 215110

    Patent Use Code : U-3238

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2032-01-19

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    ABBVIE

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    Patent Expiration Date : 2030-12-10

    GLECAPREVIR; PIBRENTASVIR

    US Patent Number : 10039754*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 209394

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2030-12-10

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    Patent Expiration Date : 2032-05-18

    GLECAPREVIR; PIBRENTASVIR

    US Patent Number : 8937150

    Drug Substance Claim : Y

    Drug Product Claim : Y

    Application Number : 209394

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2032-05-18

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    Patent Expiration Date : 2034-09-14

    GLECAPREVIR; PIBRENTASVIR

    US Patent Number : 10286029*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 215110

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2034-09-14

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    ABBVIE

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    Patent Expiration Date : 2030-11-06

    GLECAPREVIR; PIBRENTASVIR

    US Patent Number : 9586978

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 209394

    Patent Use Code : U-2141

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2030-11-06

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    ABBVIE

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    Patent Expiration Date : 2036-12-24

    GLECAPREVIR; PIBRENTASVIR

    US Patent Number : 11246866*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 209394

    Patent Use Code :

    Delist Requested :

    Patent Use Description :

    Patent Expiration Date : 2036-12-24

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    ABBVIE

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    Patent Expiration Date : 2035-12-05

    GLECAPREVIR; PIBRENTASVIR

    US Patent Number : 9321807*PED

    Drug Substance Claim :

    Drug Product Claim :

    Application Number : 209394

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    Delist Requested :

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    Patent Expiration Date : 2035-12-05

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    ABBVIE

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    Patent Expiration Date : 2035-05-08

    GLECAPREVIR; PIBRENTASVIR

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    ABOUT THIS PAGE

    Glecaprevir Manufacturers

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

    Glecaprevir Suppliers

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

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

    Glecaprevir KDMF

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

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

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

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

    Glecaprevir GMP

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

    Glecaprevir CoA

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

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

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