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    Chemistry

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    Also known as: Rifaxidin, Rifacol, 80621-81-4, Rifamycin l 105, Xifaxan, Rifamycin l 105sv
    Molecular Formula
    C43H51N3O11
    Molecular Weight
    785.9  g/mol
    InChI Key
    NZCRJKRKKOLAOJ-XRCRFVBUSA-N
    FDA UNII
    L36O5T016N
    Rifaximin
    A synthetic rifamycin derivative and anti-bacterial agent that is used for the treatment of GASTROENTERITIS caused by ESCHERICHIA COLI INFECTIONS. It may also be used in the treatment of HEPATIC ENCEPHALOPATHY.
    Rifaximin is a Rifamycin Antibacterial.
    1 2D Structure

    Rifaximin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    [(7S,9E,11S,12R,13S,14R,15R,16R,17S,18S,19E,21Z)-2,15,17,36-tetrahydroxy-11-methoxy-3,7,12,14,16,18,22,30-octamethyl-6,23-dioxo-8,37-dioxa-24,27,33-triazahexacyclo[23.10.1.14,7.05,35.026,34.027,32]heptatriaconta-1(35),2,4,9,19,21,25(36),26(34),28,30,32-undecaen-13-yl] acetate
    2.1.2 InChI
    InChI=1S/C43H51N3O11/c1-19-14-16-46-28(18-19)44-32-29-30-37(50)25(7)40-31(29)41(52)43(9,57-40)55-17-15-27(54-10)22(4)39(56-26(8)47)24(6)36(49)23(5)35(48)20(2)12-11-13-21(3)42(53)45-33(34(32)46)38(30)51/h11-18,20,22-24,27,35-36,39,48-51H,1-10H3,(H,45,53)/b12-11+,17-15+,21-13-/t20-,22+,23+,24+,27-,35-,36+,39+,43-/m0/s1
    2.1.3 InChI Key
    NZCRJKRKKOLAOJ-XRCRFVBUSA-N
    2.1.4 Canonical SMILES
    CC1C=CC=C(C(=O)NC2=C(C3=C(C4=C(C(=C3O)C)OC(C4=O)(OC=CC(C(C(C(C(C(C1O)C)O)C)OC(=O)C)C)OC)C)C5=C2N6C=CC(=CC6=N5)C)O)C
    2.1.5 Isomeric SMILES
    C[C@H]1/C=C/C=C(\C(=O)NC2=C(C3=C(C4=C(C(=C3O)C)O[C@@](C4=O)(O/C=C/[C@@H]([C@H]([C@H]([C@@H]([C@@H]([C@@H]([C@H]1O)C)O)C)OC(=O)C)C)OC)C)C5=C2N6C=CC(=CC6=N5)C)O)/C
    2.2 Other Identifiers
    2.2.1 UNII
    L36O5T016N
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 4-deoxy-4'-methylpyrido(1',2'-1,2)imidazo(5,4c)rifamycin

    2. L 105

    3. L-105

    4. L105

    5. Redactiv

    6. Xifaxan

    2.3.2 Depositor-Supplied Synonyms

    1. Rifaxidin

    2. Rifacol

    3. 80621-81-4

    4. Rifamycin L 105

    5. Xifaxan

    6. Rifamycin L 105sv

    7. Fatroximin

    8. Rifaximine

    9. Normix

    10. Rifaximina

    11. Xifaxsan

    12. L-105

    13. Rifamixin

    14. Rifaximine [french]

    15. Rifaximinum [latin]

    16. Rifaximina [spanish]

    17. Ritacol

    18. Chebi:75246

    19. 4-deoxy-4'-methylpyrido(1',2'-1,2)imidazo(5,4-c)rifamycin Sv

    20. L36o5t016n

    21. Rifaximin (xifaxan)

    22. Nsc-758957

    23. Rifaximinum

    24. Brn 3584528

    25. (2s,16z,18e,20s,21s,22r,23r,24r,25s,26r,27s,28e)-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-1,15-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienoimino)furo[2'',3'':7',8']naphtho[1',2':4,5]imidazo[1,2-a]pyridin-25-yl Acetate

    26. C43h51n3o11

    27. Rifaxin

    28. Redactiv

    29. Ido[1,2-a]benzimidazol-25-yl Acetate

    30. (2s,16z,18e,20s,21s,22r,23r,24r,25s,26r,27s,28e)-25-(acetyloxy)-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca[1,11,13]trienimino)benzofuro[4,5-e]pyrido[1,2-a]benzimidazole-1,15(2h)-dione

    31. L 105sv

    32. L 105 (ansamacrolide Antibiotic)

    33. L 105

    34. Rifaximinun

    35. Flonorm

    36. Lumenax

    37. Spiraxin

    38. Lormyx

    39. Rifaximin [usan:inn:ban]

    40. Unii-l36o5t016n

    41. 5-yl Acetate

    42. Ncgc00095842-01

    43. (2s,16z,18e,20s,21s,22r,23r,24r,25s,26r,27s,28e)-25-(acetyloxy)-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca(1,11,13)trienimino)benzofuro(4,5-e)pyrido(1,2-a)benzimidazole-1,15(2h)-dione

    44. (2s,16z,18e,20s,21s,22r,23r,24r,25s,26r,27s,28e)5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-1,15-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienoimino)[1]benzofuro[4,5-e]pyr

    45. Xifaxan (tn)

    46. Mfcd00864973

    47. Rifaximin [inn]

    48. Rifaximin [jan]

    49. Rifaximin [mi]

    50. Rifaximin [usan]

    51. Rifaximin [vandf]

    52. Rifaximin [mart.]

    53. Alpha-0817185

    54. Rifaximin [who-dd]

    55. Chembl1617

    56. Dsstox_cid_25998

    57. Dsstox_rid_81280

    58. Dsstox_gsid_45998

    59. (2s,16z,18e,20s,21s,22r,23r,24r,25s,26s,27s,28e)-5,6,21,23,25 Pentahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-2,7-(epoxypentadeca(1,11,13)trienimino)benzofuro(4,5-e)pyrido(1,2-a)benzimidazole-1,15(2h)-dione, 25-acetate

    60. Rifaximin (jan/usan/inn)

    61. Schembl124066

    62. Rifaximin [ep Impurity]

    63. Rifaximin [orange Book]

    64. Dtxsid7045998

    65. Rifaximin [ep Monograph]

    66. Gtpl12012

    67. Hms3715b19

    68. 88747-56-2

    69. Tox21_111529

    70. Bdbm50347620

    71. S1790

    72. Akos015963053

    73. Zinc169621200

    74. Ccg-221129

    75. Db01220

    76. Nsc 758957

    77. Rifaximin 100 Microg/ml In Acetonitrile

    78. 2,7-(epoxy(1,11,13)pentadecatrienoimino)furo(2'',3'':7',8')naphth(1',2':4,5)imidazo(1,2-a)pyridine-1,15(2h)-dione, 25-(acetyloxy)-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-, ( 2s,16z,18e,20s,21s,22r,23r,24r,25s,26r,27s,28e)-

    79. 2,7-(epoxypentadeca(1,11,13)trienimino)benzofuro(4,5-e)pyrido(1,2-a)benzimidazole-1,15(2h)-dione, 25-(acetyloxy)-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-, (2s-(2r*,16z,18e,20r*,21r*,22s*,23s*,24s*,25r*,26s*,27r*,28e))-

    80. Ac-19112

    81. Cas-80621-81-4

    82. L/105

    83. D02554

    84. Ab01209738-01

    85. Ab01209738-03

    86. Ab01209738_04

    87. Rifaximin, Antibiotic For Culture Media Use Only

    88. 621r814

    89. Q416073

    90. Q-201671

    91. (2s,16z,18e,20s,21s,22r,23r,24r,25s,26r,27s,28e)-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-1,1

    92. (7s,11s,12r,13s,14r,15r,16r,17s,18s)-2,15,17,36-tetrahydroxy-11-methoxy-3,7,12,14,16,18,22,30-octamethyl-6,23-dioxo-8,37-dioxa-24,27,33-triazahexacyclo[23.10.1.1^{4,7}.0^{5,35}.0^{26,34}.0^{27,32}]heptatriaconta-1,3,5(35),9,19,21,25(36),26(34),28,30,32-undecaen-13-yl Acetate

    93. [(7s,9e,11s,12r,13s,14r,15r,16r,17s,18s,19e,21z)-2,15,17,36-tetrahydroxy-11-methoxy-3,7,12,14,16,18,22,30-octamethyl-6,23-dioxo-8,37-dioxa-24,27,33-triazahexacyclo[23.10.1.14,7.05,35.026,34.027,32]heptatriaconta-1(35),2,4,9,19,21,25(36),26(34),28,30,32-undecaen-13-yl] Acetate

    94. 2,7-(epoxypentadeca(1,11,13)trienimino)benzofuro(4,5-e)pyrido(1,2-a)benzimidazole-1,15(2h)-dione, 25-(acetyloxy)-5,6,21,23-tetrahydroxy-27-methoxy-2,4,11,16,20,22,24,26-octamethyl-, (2s,16z,18e,20s,21s,22r,23r,24r,25s,26r,27s,28e)-

    95. 5-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienoimino)furo[2'',3'':7',8']naphtho[1',2':4,5]imidazo[1,2-a]pyridin-2

    2.4 Create Date
    2006-04-28
    3 Chemical and Physical Properties
    Molecular Weight 785.9 g/mol
    Molecular Formula C43H51N3O11
    XLogP36.9
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count12
    Rotatable Bond Count3
    Exact Mass785.35235945 g/mol
    Monoisotopic Mass785.35235945 g/mol
    Topological Polar Surface Area198 Ų
    Heavy Atom Count57
    Formal Charge0
    Complexity1590
    Isotope Atom Count0
    Defined Atom Stereocenter Count9
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count3
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameXifaxan
    PubMed HealthRifaximin (By mouth)
    Drug ClassesAntibiotic
    Drug LabelXIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2 ,16 ,18 ,20 ,21 ,22 ,23 ,24 ,25 ,26 ,27...
    Active IngredientRifaximin
    Dosage FormTablet
    RouteOral
    Strength200mg; 550mg
    Market StatusPrescription
    CompanySalix Pharms

    2 of 2  
    Drug NameXifaxan
    PubMed HealthRifaximin (By mouth)
    Drug ClassesAntibiotic
    Drug LabelXIFAXAN tablets contain rifaximin, a non-aminoglycoside semi-synthetic, nonsystemic antibiotic derived from rifamycin SV. Rifaximin is a structural analog of rifampin. The chemical name for rifaximin is (2 ,16 ,18 ,20 ,21 ,22 ,23 ,24 ,25 ,26 ,27...
    Active IngredientRifaximin
    Dosage FormTablet
    RouteOral
    Strength200mg; 550mg
    Market StatusPrescription
    CompanySalix Pharms

    4.2 Drug Indication

    Rifaximin has multiple indications by the FDA: for the treatment of patients (12 years of age) with traveller's diarrhea caused by noninvasive strains of Escherichia coli; for the reduction of overt hepatic encephalopathy recurrence in patients 18 years of age; and in May 2015 it was approved for irritable bowel syndrome with diarrhea (IBS-D) treatment in adult men and women.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Rifaximin is a structural analog of rifampin and a non-systemic, gastrointestinal site-specific antibiotic. This non-systemic property of the drug is due to the addition of a pyridoimidazole ring, which renders it non-absorbable. Rifaximin acts by inhibiting bacterial ribonucleic acid (RNA) synthesis and contributes to restore intestinal microflora imbalance. Other studies have also shown rifaximin to be an pregnane X receptor (PXR) activator. As PXR is responsible for inhibiting the proinflammatory transcription factor NF-kappa B (NF-B) and is inhibited in inflammatory bowel disease (IBD), rifaximin was proven to be effective for the treatment of IBS-D.

    5.2 MeSH Pharmacological Classification

    Anti-Bacterial Agents

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

    Gastrointestinal Agents

    Drugs used for their effects on the gastrointestinal system, as to control gastric acidity, regulate gastrointestinal motility and water flow, and improve digestion. (See all compounds classified as Gastrointestinal Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    RIFAXIMIN
    5.3.2 FDA UNII
    L36O5T016N
    5.3.3 Pharmacological Classes
    Rifamycins [CS]; Rifamycin Antibacterial [EPC]
    5.4 ATC Code

    A07AA11

    S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355

    A - Alimentary tract and metabolism

    A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents

    A07A - Intestinal antiinfectives

    A07AA - Antibiotics

    A07AA11 - Rifaximin

    D - Dermatologicals

    D06 - Antibiotics and chemotherapeutics for dermatological use

    D06A - Antibiotics for topical use

    D06AX - Other antibiotics for topical use

    D06AX11 - Rifaximin

    5.5 Absorption, Distribution and Excretion

    Absorption

    Low absorption in both the fasting state and when administered within 30 minutes of a high-fat breakfast.

    Route of Elimination

    In a mass balance study, after administration of 400 mg 14C-rifaximin orally to healthy volunteers, of the 96.94% total recovery, 96.62% of the administered radioactivity was recovered in feces almost exclusively as the unchanged drug and 0.32% was recovered in urine mostly as metabolites with 0.03% as the unchanged drug.Rifaximin accounted for 18% of radioactivity in plasma. This suggests that the absorbed rifaximin undergoes metabolism with minimal renal excretion of the unchanged drug

    5.6 Metabolism/Metabolites

    In vitro drug interactions studies have shown that rifaximin, at concentrations ranging from 2 to 200 ng/mL, did not inhibit human hepatic cytochrome P450 isoenzymes: 1A2, 2A6, 2B6, 2C9, 2C19, 2D6, 2E1, and 3A4. In an in vitro hepa-tocyte induction model, rifaximin was shown to induce cytochrome P450 3A4 (CYP3A4), an isoenzyme which rifampin is known to induce.

    5.7 Biological Half-Life

    Approximately 6 hours.

    5.8 Mechanism of Action

    Rifaximin acts by inhibiting RNA synthesis in susceptible bacteria by binding to the beta-subunit of bacterial deoxyribonucleic acid (DNA)-dependent ribonucleic acid (RNA) polymerase enzyme. This binding blocks translocation, which stops transcription.

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    Valid Till : 2025-06-28

    Written Confirmation Number : WC-0024

    Address of the Firm :

    NDC arrow-down
    ✖

    NDC Package Code : 62207-020

    Start Marketing Date : 2023-08-30

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Available Reg Filing : ASMF
    AUDIT
    Granules India

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    07

    Granules India Limited

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    CPhI China
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Virtual Booth Virtual Booth
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    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38843

    Submission : 2024-03-07

    Status : Active

    Type : II

     CEP/COS arrow-down
    ✖

    Certificate Number : CEP 2021-377 - Rev 01

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 2362

    Status : Valid

     JDMF EU-WC NDC arrow-down
    ✖

    NDC Package Code : 62207-017

    Start Marketing Date : 2021-12-20

    End Marketing Date : 2026-12-31

    Dosage Form (Strength) : POWDER (1kg/kg)

    Marketing Category : BULK INGREDIENT

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    Available Reg Filing : ASMF
    AUDIT
    Granules India

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    08

    Luohe Nanjiecun Pharmac. Group Pha...

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BPI Europe
    Not Confirmed
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    Luohe Nanjiecun Pharmac. Group Pha...

    China

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BPI Europe
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 35704

    Submission : 2021-09-27

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    09

    Raks Pharma

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BPI Europe
    Not Confirmed
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    Raks Pharma

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    BPI Europe
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2015-03-27

    Pay. Date : 2014-12-12

    DMF Number : 28906

    Submission : 2015-02-03

    Status : Active

    Type : II

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    10

    Solara Active Pharma Sciences

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    BPI Europe
    Not Confirmed
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    Solara Active Pharma Sciences

    India

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    arrow
    BPI Europe
    Not Confirmed
    USDMF arrow-down
    ✖

    GDUFA

    DMF Review : Reviewed

    Rev. Date : 2016-03-16

    Pay. Date : 2015-09-08

    DMF Number : 29359

    Submission : 2015-05-11

    Status : Active

    Type : II

     CEP/COS JDMF EU-WCInactive-api
    ✖

    Date of Issue : 2021-08-06

    Valid Till : 2024-03-04

    Written Confirmation Number : WC-0294

    Address of the Firm :

    NDC KDMF VMF Others AUDIT
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    USDMF

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    Euroapi Italy Srl

    France
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    TIDES USA
    Booth #414, Level 1
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17150

    Submission : 2004-02-10

    Status : Active

    Type : II

    EUROAPI Compnay Banner

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    Product Web Link

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    Digital Content

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    02

    Granules India Ltd

    India
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    CPhI China
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 36125

    Submission : 2021-08-29

    Status : Active

    Type : II

    Granules India

    Portfolio PDF

    Product Web Link

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    Digital Content

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    03

    Granules India Ltd

    India
    arrow
    CPhI China
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 38843

    Submission : 2024-03-07

    Status : Active

    Type : II

    Granules India

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    Product Web Link

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    04

    BioProcess International Europe
    Not Confirmed

    04

    Fis Fabbrica Italiana Sintetici Spa

    Italy
    arrow
    BioProcess International Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 15635

    Submission : 2001-09-20

    Status : Active

    Type : II

    blank

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    05

    Lupin Ltd

    India

    USDMF

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    BioProcess International Europe
    Not Confirmed

    05

    Lupin Ltd

    India
    arrow
    BioProcess International Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 20436

    Submission : 2007-03-31

    Status : Inactive

    Type : II

    blank

    Portfolio PDF

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    Virtual Booth

    Digital Content

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    06

    BioProcess International Europe
    Not Confirmed

    06

    Msn Laboratories Private Ltd

    India
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    BioProcess International Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 28096

    Submission : 2014-03-28

    Status : Inactive

    Type : II

    blank

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    Product Web Link

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    07

    BioProcess International Europe
    Not Confirmed

    07

    Msn Laboratories Private Ltd

    India
    arrow
    BioProcess International Europe
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-10-27

    Pay. Date : 2015-09-18

    DMF Number : 28097

    Submission : 2014-03-28

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

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    08

    Olon Spa

    Italy

    USDMF

    arrow
    BioProcess International Europe
    Not Confirmed

    08

    Olon Spa

    Italy
    arrow
    BioProcess International Europe
    Not Confirmed

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 17974

    Submission : 2004-12-14

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    09

    Raks Pharma Pvt Ltd

    India

    USDMF

    arrow
    BioProcess International Europe
    Not Confirmed

    09

    Raks Pharma Pvt Ltd

    India
    arrow
    BioProcess International Europe
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2015-03-27

    Pay. Date : 2014-12-12

    DMF Number : 28906

    Submission : 2015-02-03

    Status : Active

    Type : II

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    10

    BioProcess International Europe
    Not Confirmed

    10

    Solara Active Pharma Sciences Ltd

    India
    arrow
    BioProcess International Europe
    Not Confirmed

    GDUFA

    DMF Review : Complete

    Rev. Date : 2016-03-16

    Pay. Date : 2015-09-08

    DMF Number : 29359

    Submission : 2015-05-11

    Status : Active

    Type : II

    blank

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    CEP/COS

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    GRANULES INDIA LIMITED Hyderabad IN

    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Rifaximin

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    CEP 2012-146 - Rev 02
    Valid
    Chemical
    2024-06-10
    2362
    Granules India

    01

    GRANULES INDIA LIMITED Hyderabad IN

    India
    arrow
    CPhI China
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Rifaximin

    Certificate Number : CEP 2012-146 - Rev 02

    Status : Valid

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 2362

    Granules India

    Portfolio PDF

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    GRANULES INDIA LIMITED Hyderabad IN

    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Rifaximin, [RSA code] Process-II

    Portfolio PDF

    Product Web Link

    Virtual Booth

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    CEP 2021-377 - Rev 01
    Valid
    Chemical
    2024-06-10
    2362
    Granules India

    02

    GRANULES INDIA LIMITED Hyderabad IN

    India
    arrow
    CPhI China
    Attending
    • fda
    • EDQM
    • WHO-GMP

    Virtual BoothGranules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

    Contact Supplier Contact Supplier
    Flag India
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Rifaximin, [RSA Code] Process-II

    Certificate Number : CEP 2021-377 - Rev 01

    Status : Valid

    Issue Date : 2024-06-10

    Type : Chemical

    Substance Number : 2362

    Granules India

    Portfolio PDF

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    Digital Content

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    Cambrex Profarmaco Milano S.r.l. Pa...

    Contact Supplier
    • FDA
    • EDQM
    • fda
    • EDQM
    • WHO-GMP
    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.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Rifaximin

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

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    CEP 2020-435 - Rev 00
    Valid
    Chemical
    2024-02-12
    2362
    blank

    03

    Cambrex Profarmaco Milano S.r.l. Pa...

    U.S.A
    BioProcess International Europe
    Not Confirmed
    arrow

    Cambrex Profarmaco Milano S.r.l. Pa...

    U.S.A
    arrow
    BioProcess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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.
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    Rifaximin

    Certificate Number : CEP 2020-435 - Rev 00

    Status : Valid

    Issue Date : 2024-02-12

    Type : Chemical

    Substance Number : 2362

    blank

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    Digital Content

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    Cosma S.p.A. Ciserano IT

    Contact Supplier
    • FDA
    • fda
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    • WHO-GMP
    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.
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    Flag Italy
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Rifaximin

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    CEP 2022-368 - Rev 00
    Valid
    Chemical
    2024-09-02
    2362
    blank

    04

    Cosma S.p.A. Ciserano IT

    Italy
    BioProcess International Europe
    Not Confirmed
    arrow

    Cosma S.p.A. Ciserano IT

    Italy
    arrow
    BioProcess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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.
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    Virtual Booth Virtual Booth
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    Rifaximin

    Certificate Number : CEP 2022-368 - Rev 00

    Status : Valid

    Issue Date : 2024-09-02

    Type : Chemical

    Substance Number : 2362

    blank

    Portfolio PDF

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    Digital Content

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    F.I.S. - FABBRICA ITALIANA SINTETIC...

    Contact Supplier
    • FDA
    • EDQM
    • fda
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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.
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Rifaximin, Form α

    Portfolio PDF

    Product Web Link

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    Digital Content

    Website

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    R1-CEP 2010-085 - Rev 01
    Valid
    Chemical
    2018-10-12
    2362
    blank

    05

    F.I.S. - FABBRICA ITALIANA SINTETIC...

    Italy
    BioProcess International Europe
    Not Confirmed
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    F.I.S. - FABBRICA ITALIANA SINTETIC...

    Italy
    arrow
    BioProcess International Europe
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    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.
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    Virtual Booth Virtual Booth
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    Rifaximin, Form α

    Certificate Number : R1-CEP 2010-085 - Rev 01

    Status : Valid

    Issue Date : 2018-10-12

    Type : Chemical

    Substance Number : 2362

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    LUOHE CHIEF PHARMACEUTICAL CO., LTD...

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      • fda
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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.
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      Rifaximin

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      R0-CEP 2021-420 - Rev 00
      Valid
      Chemical
      2023-06-06
      2362
      blank

      06

      LUOHE CHIEF PHARMACEUTICAL CO., LTD...

      China
      BioProcess International Europe
      Not Confirmed
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      LUOHE CHIEF PHARMACEUTICAL CO., LTD...

      China
      arrow
      BioProcess International Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Rifaximin

      Certificate Number : R0-CEP 2021-420 - Rev 00

      Status : Valid

      Issue Date : 2023-06-06

      Type : Chemical

      Substance Number : 2362

      blank

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      LUPIN LIMITED Mumbai IN

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      • EDQM
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      • fda
      • EDQM
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      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Rifaximin

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      R0-CEP 2020-175 - Rev 00
      Valid
      Chemical and TSE
      2022-12-07
      2362
      blank

      07

      LUPIN LIMITED Mumbai IN

      India
      BioProcess International Europe
      Not Confirmed
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      LUPIN LIMITED Mumbai IN

      India
      arrow
      BioProcess International Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Rifaximin

      Certificate Number : R0-CEP 2020-175 - Rev 00

      Status : Valid

      Issue Date : 2022-12-07

      Type : Chemical and TSE

      Substance Number : 2362

      blank

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      MSN LABORATORIES PRIVATE LIMITED Ru...

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      • FDA
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      • fda
      • EDQM
      • WHO-GMP
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      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Rifaximin, α-Form

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      CEP 2016-016 - Rev 01
      Valid
      Chemical
      2024-02-28
      2362
      blank

      08

      MSN LABORATORIES PRIVATE LIMITED Ru...

      India
      BioProcess International Europe
      Not Confirmed
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      OLON S.P.A. Rodano IT

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      • FDA
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      • fda
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      • WHO-GMP
      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.
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      Virtual Booth Virtual Booth
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      Rifaximin, Alpha Form

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      R0-CEP 2019-125 - Rev 03
      Valid
      Chemical
      2021-07-05
      2362
      blank

      09

      OLON S.P.A. Rodano IT

      Italy
      BioProcess International Europe
      Not Confirmed
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      OPTIMUS DRUGS PRIVATE LIMITED Hyder...

      Contact Supplier
      • WHO-GMP
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Digital Content Digital Content

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      R0-CEP 2020-303 - Rev 01
      Valid
      Chemical
      2022-06-29
      2362
      blank

      10

      OPTIMUS DRUGS PRIVATE LIMITED Hyder...

      India
      BioProcess International Europe
      Not Confirmed
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      OPTIMUS DRUGS PRIVATE LIMITED Hyder...

      India
      arrow
      BioProcess International Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Rifaximin

      Certificate Number : R0-CEP 2020-303 - Rev 01

      Status : Valid

      Issue Date : 2022-06-29

      Type : Chemical

      Substance Number : 2362

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      API Reference Price

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ROPP21009A(INTERMEDIATE FOR RIFAXIMIN)","address":"ALEMBIC PHARMACEUTICALS LTD\\r\\nALEMBIC ROAD","city":"VADODARA","supplier":"CKD BIO CORPORATION","supplierCountry":"KOREA, REPUBLIC OF","foreign_port":"SEOUL - INCHEON INT\\'","customer":"ALEMBIC PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"5.00","actualQuantity":"5","unit":"KGS","unitRateFc":"400","totalValueFC":"2010.7","currency":"USD","unitRateINR":"29580","date":"08-Sep-2021","totalValueINR":"147900","totalValueInUsd":"2010.7","indian_port":"BOMBAY AIR","hs_no":"29419090","bill_no":"5365633","productDescription":"Intermediate","marketType":"REGULATED MARKET","country":"KOREA,REPUBLIC OF","selfForZScoreResived":"Pharma Grade","supplierPort":"SEOUL - INCHEON INT\\'","supplierAddress":"","customerAddress":"ALEMBIC PHARMACEUTICALS LTD\\r\\nALEMBIC ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669055400,"product":"RIFAXIMIN","address":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI","city":"GARDEN CITY OFF WESTERN EXPR HIGHWA","supplier":"CAMBREX CORPORATION","supplierCountry":"ITALY","foreign_port":"NA","customer":"TEVA PHARMACEUTICAL INDUSTRIES","customerCountry":"INDIA","quantity":"208.11","actualQuantity":"208.11","unit":"KGS","unitRateFc":"2000","totalValueFC":"421255.3","currency":"USD","unitRateINR":"165200","date":"22-Nov-2022","totalValueINR":"34379772","totalValueInUsd":"421255.3","indian_port":"BOMBAY AIR","hs_no":"29419019","bill_no":"3421453","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"12TH FLOOR, COMMERZ II,,INTERNATIO NAL BUSNESS PARK,OBEROI"},{"dataSource":"API Import","activeIngredients":"","year":"2022","qtr":"Q4","strtotime":1669228200,"product":"RIFAXIMIN PH.EUR TEST LIC. 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","supplierCountry":"CHINA","foreign_port":"BEIJING","customer":"RV LIFESCIENCES LIMITED","customerCountry":"INDIA","quantity":"25.00","actualQuantity":"25","unit":"KGS","unitRateFc":"260","totalValueFC":"6646.1","currency":"USD","unitRateINR":"22126.2","date":"03-Oct-2023","totalValueINR":"553154.06","totalValueInUsd":"6646.1","indian_port":"Bombay Air","hs_no":"29333990","bill_no":"8125529","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BEIJING","supplierAddress":"NO.168, LONGJIANG ROADYANCHENG DISTRICT, LUOHECITY HENAN PROVINCE CHINA","customerAddress":"H.O.ANJALI COMPLEX,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699986600,"product":"RIFAXIMIN, CAS NO. 80621-81-4, BATCH NO. 230701","address":"ACME PLAZA , ANDHERI KURLA ROAD","city":"MUMBAI","supplier":"N\/A","supplierCountry":"CHINA","foreign_port":"N\/A","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"80.00","actualQuantity":"80","unit":"KGS","unitRateFc":"120","totalValueFC":"9701.4","currency":"USD","unitRateINR":"10098","date":"15-Nov-2023","totalValueINR":"807840","totalValueInUsd":"9701.4","indian_port":"Delhi Air","hs_no":"29419090","bill_no":"8776990","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"N\/A","supplierAddress":"N\/A","customerAddress":"ACME PLAZA , ANDHERI KURLA ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701714600,"product":"RIFAXIMIN PH. EUR 10","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. AP","supplier":"EL-OBOUR MODERN PHARMACEUTICAL INDUSTRIES CO.","supplierCountry":"EGYPT","foreign_port":"CAIRO","customer":"OPTIMUS DRUGS PRIVATE ","customerCountry":"INDIA","quantity":"124.00","actualQuantity":"124","unit":"KGS","unitRateFc":"201.6","totalValueFC":"25257","currency":"USD","unitRateINR":"16955.4","date":"05-Dec-2023","totalValueINR":"2102469.72","totalValueInUsd":"25257","indian_port":"Hyderabad Air","hs_no":"29419090","bill_no":"9084126","productDescription":"API","marketType":"","country":"EGYPT","selfForZScoreResived":"Pharma Grade","supplierPort":"CAIRO","supplierAddress":"EL OBOUR CITY-1ST INDUSTRIAL ZONE-BLOCK NO 13024, EGYPTSDNF Egypt","customerAddress":"PLOT NO.131,3RD FLOOR,NARMADA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1701973800,"product":"RIFAXIMIN BP\/EP","address":"236 OKHLA INDUSTRIAL ESTATE,","city":"NEW DELHI","supplier":"LUOHE CHAMP GROWING ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ANM PHARMA PVT LTD","customerCountry":"INDIA","quantity":"1000.00","actualQuantity":"1000","unit":"KGS","unitRateFc":"129","totalValueFC":"130760.3","currency":"USD","unitRateINR":"10884.9","date":"08-Dec-2023","totalValueINR":"10884901.83","totalValueInUsd":"130760.3","indian_port":"JNPT","hs_no":"29419090","bill_no":"9129540","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 408-410, GONGSHANGLIAN BUILDING, NENJIANG ROAD,YANCHENG DIST-LUOHE CITY, HENAN PROVINCE,P.R.CHINA ., CHINA","customerAddress":"236 OKHLA INDUSTRIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q2","strtotime":1717612200,"product":"RIFAXIMIN BP\/EP","address":"236 OKHLA INDUSTRIAL ESTATE,","city":"NEW DELHI","supplier":"LUOHE CHAMP GROWING ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ANM PHARMA PVT LTD","customerCountry":"INDIA","quantity":"302.72","actualQuantity":"302.72","unit":"KGS","unitRateFc":"129","totalValueFC":"39495.1","currency":"USD","unitRateINR":"10891.3","date":"06-Jun-2024","totalValueINR":"3297024.03","totalValueInUsd":"39495.1","indian_port":"JNPT","hs_no":"29419090","bill_no":"3852601","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"ROOM 408-410, GONGSHANGLIAN BUILDING, NENJIANG ROAD,YANCHENG DIST-LUOHE CITY, HENAN PROVINCE,P.R.CHINA ., CHINA","customerAddress":"236 OKHLA INDUSTRIAL ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1726425000,"product":"RIFAXIMIN","address":"304,ATLANTA ARCADE,","city":"MUMBAI MAHARASHTRA","supplier":"LUOHE CHIEF PHARMACEUTICAL CO. LTD.","supplierCountry":"CHINA","foreign_port":"CHENGDU","customer":"MACLEODS PHARMACEUTICALS LIMITED","customerCountry":"INDIA","quantity":"263.00","actualQuantity":"263","unit":"KGS","unitRateFc":"137","totalValueFC":"37055","currency":"USD","unitRateINR":"11807.1","date":"16-Sep-2024","totalValueINR":"3105257.06","totalValueInUsd":"37055","indian_port":"Bombay Air","hs_no":"29419019","bill_no":"5621959","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHENGDU","supplierAddress":"NO.168 LONGJIANG ROAD YANCHENG DISTRICT LUOHE CITY HENAN PROVINCE CHINA CHINA","customerAddress":"304,ATLANTA ARCADE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1742409000,"product":"RIFAXIMIN RIFAXIMIN","address":"ACME PLAZA , ANDHERI KURLA ROAD","city":"MUMBAI","supplier":"M\/S. LUOHE CHIEF PHARMACEUTICAL CO. LTD","supplierCountry":"CHINA","foreign_port":"CHANGSHA","customer":"SUN PHARMACEUTICAL INDUSTRIES LIMITED","customerCountry":"INDIA","quantity":"4000.00","actualQuantity":"4000","unit":"KGS","unitRateFc":"122","totalValueFC":"494661.7","currency":"USD","unitRateINR":"10711.6","date":"20-Mar-2025","totalValueINR":"42846400","totalValueInUsd":"494661.7","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"8999481","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHANGSHA","supplierAddress":"NO.168, LONGJIANG RD., YANCHENG DISTRICT LUOHE CITY HENAN PROVINCE CN","customerAddress":"ACME PLAZA , ANDHERI KURLA ROAD"}]
      05-Jan-2021
      25-Mar-2025
      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

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      API Imports and Exports

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

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      FDA Orange Book

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      01

      NORWICH

      U.S.A
      CST
      Not Confirmed
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      NORWICH

      U.S.A
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      CST
      Not Confirmed
      • fda
      • EDQM
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      RLD :

      TE Code :

      RIFAXIMIN

      Brand Name : RIFAXIMIN

      Dosage Form : TABLET;ORAL

      Dosage Strength : 200MG

      Approval Date :

      Application Number : 214370

      RX/OTC/DISCN :

      RLD :

      TE Code :

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      02

      NORWICH PHARMACEUTICALS INC

      U.S.A
      CST
      Not Confirmed
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      NORWICH PHARMACEUTICALS INC

      U.S.A
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      CST
      Not Confirmed
      • fda
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      • WHO-GMP
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      RLD :

      TE Code :

      RIFAXIMIN

      Brand Name : RIFAXIMIN

      Dosage Form : TABLET;ORAL

      Dosage Strength : 550MG

      Approval Date :

      Application Number : 214369

      RX/OTC/DISCN :

      RLD :

      TE Code :

      blank

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      03

      SALIX PHARMS

      U.S.A
      CST
      Not Confirmed
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      SALIX PHARMS

      U.S.A
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      CST
      Not Confirmed
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      RLD : Yes

      TE Code :

      RIFAXIMIN

      Brand Name : XIFAXAN

      Dosage Form : TABLET;ORAL

      Dosage Strength : 200MG

      Approval Date : 2004-05-25

      Application Number : 21361

      RX/OTC/DISCN : RX

      RLD : Yes

      TE Code :

      blank

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      04

      SALIX PHARMS

      U.S.A
      CST
      Not Confirmed
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      SALIX PHARMS

      U.S.A
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      CST
      Not Confirmed
      • fda
      • EDQM
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      RLD : Yes

      TE Code :

      RIFAXIMIN

      Brand Name : XIFAXAN

      Dosage Form : TABLET;ORAL

      Dosage Strength : 550MG

      Approval Date : 2010-03-24

      Application Number : 21361

      RX/OTC/DISCN : RX

      RLD : Yes

      TE Code :

      blank

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      05

      SALIX PHARMS

      U.S.A
      CST
      Not Confirmed
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      SALIX PHARMS

      U.S.A
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      CST
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
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      Digital Content Digital Content

      RLD :

      TE Code :

      RIFAXIMIN

      Brand Name : XIFAXAN

      Dosage Form : TABLET;ORAL

      Dosage Strength : 550MG

      Approval Date :

      Application Number : 22554

      RX/OTC/DISCN :

      RLD :

      TE Code :

      blank

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      06

      SANDOZ INC

      Switzerland
      CST
      Not Confirmed
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      SANDOZ INC

      Switzerland
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      CST
      Not Confirmed
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      RLD :

      TE Code :

      RIFAXIMIN

      Brand Name : RIFAXIMIN

      Dosage Form : TABLET;ORAL

      Dosage Strength : 550MG

      Approval Date :

      Application Number : 213713

      RX/OTC/DISCN :

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      Europe

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      01

      ALFRED E TIEFENBACHER GmbH & Co KG

      Germany
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      CST
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      • fda
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      Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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      Regulatory Info : EU Dossier Readiness-Q1 2020

      Registration Country : Germany

      Rifaximin

      Brand Name :

      Dosage Form : Film Coated Tablet

      Dosage Strength : 200MG

      Packaging :

      Approval Date :

      Application Number :

      Regulatory Info : EU Dossier Readiness-Q1 2020

      Registration Country : Germany

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      02

      ALFRED E TIEFENBACHER GmbH & Co KG

      Germany
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      Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

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      Flag Germany
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      Regulatory Info : EU Dossier Readiness-Q1 2020

      Registration Country : Germany

      Rifaximin

      Brand Name :

      Dosage Form : Film Coated Tablet

      Dosage Strength : 550MG

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      Approval Date :

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      Regulatory Info : EU Dossier Readiness-Q1 2020

      Registration Country : Germany

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      03

      Alfa Wasserman SpA,

      Italy
      CST
      Not Confirmed
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      Alfa Wasserman SpA,

      Italy
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      CST
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
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      Regulatory Info :

      Registration Country : Sweden

      rifaximin

      Brand Name : Tixteller

      Dosage Form : FILM COATED PILL

      Dosage Strength : 550 MG

      Packaging :

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      Application Number :

      Regulatory Info :

      Registration Country : Sweden

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      04

      ALFA WASSERMANN SpA

      Italy
      BioProcess International Europe
      Not Confirmed
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      ALFA WASSERMANN SpA

      Italy
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      BioProcess International Europe
      Not Confirmed
      • fda
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      Regulatory Info :

      Registration Country : Italy

      Rifaximin

      Brand Name : Normix

      Dosage Form : Rifaximin 200Mg 12 Combined Oral Use

      Dosage Strength : 12 cpr riv 200 mg

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      Application Number :

      Regulatory Info :

      Registration Country : Italy

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      05

      ALFA WASSERMANN SpA

      Italy
      CST
      Not Confirmed
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      ALFA WASSERMANN SpA

      Italy
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      CST
      Not Confirmed
      • fda
      • EDQM
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      Rifaximin

      Brand Name : Normix

      Dosage Form : Rifaximin 60Ml 100Mg/Ml Oral Use

      Dosage Strength : os grat suspe 60 ml 2 g/100 ml

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      Registration Country : Italy

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      06

      Alfasigma Schweiz AG

      Italy
      CST
      Not Confirmed
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      Alfasigma Schweiz AG

      Italy
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      CST
      Not Confirmed
      • fda
      • EDQM
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      Regulatory Info :

      Registration Country : Switzerland

      Rifaximin

      Brand Name : Xifaxan

      Dosage Form : Film-Coated Tablets

      Dosage Strength : 550mg

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      Regulatory Info :

      Registration Country : Switzerland

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      07

      GRUNENTHAL ITALIA Srl

      Germany
      CST
      Not Confirmed
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      GRUNENTHAL ITALIA Srl

      Germany
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      CST
      Not Confirmed
      • fda
      • EDQM
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      Regulatory Info :

      Registration Country : Italy

      Rifaximin

      Brand Name : Rifacol

      Dosage Form : Rifaximin 200Mg 12 Combined Oral Use

      Dosage Strength : AD 12 cpr riv 200 mg

      Packaging :

      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : Italy

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      08

      GRUNENTHAL ITALIA Srl

      Germany
      CST
      Not Confirmed
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      GRUNENTHAL ITALIA Srl

      Germany
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      CST
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Regulatory Info :

      Registration Country : Italy

      Rifaximin

      Brand Name : Rifacol

      Dosage Form : Rifaximin 60Ml 100Mg/Ml Oral Use

      Dosage Strength : os grat suspe 60 ml 2 g/100 ml

      Packaging :

      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : Italy

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      09

      Norgine BV

      Netherlands
      BioProcess International Europe
      Not Confirmed
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      Norgine BV

      Netherlands
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      BioProcess International Europe
      Not Confirmed
      • fda
      • EDQM
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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.
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      Flag Netherlands
      Virtual Booth Virtual Booth
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      Regulatory Info :

      Registration Country : Sweden

      rifaximin

      Brand Name : Xifaxan

      Dosage Form : FILM COATED PILL

      Dosage Strength : 550 MG

      Packaging :

      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : Sweden

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      10

      Norgine BV

      Netherlands
      BioProcess International Europe
      Not Confirmed
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      Norgine BV

      Netherlands
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      BioProcess International Europe
      Not Confirmed
      • fda
      • EDQM
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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.
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      Flag Netherlands
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      Regulatory Info :

      Registration Country : Norway

      Rifaximin

      Brand Name : Xifaxan

      Dosage Form : Antic-calc Tablet, Film Coated

      Dosage Strength : 550 mg

      Packaging : Blister

      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : Norway

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      Listed Dossiers

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      01

      Faran Shimi Pharmaceutical

      Iran
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      BPI Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

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

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      Regulatory Info :

      Registration Country : Iran

      Rifaximin

      Brand Name :

      Dosage Form : Film Coated Tablet

      Dosage Strength : 200MG

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      Regulatory Info :

      Registration Country : Iran

      Faran Shimi Pharmaceutical

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      01

      Faran Shimi Pharmaceutical

      Iran
      arrow
      BPI Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

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

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      Flag Iran
      Virtual Booth Virtual Booth
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      Packaging :

      Regulatory Info :

      Rifaximin

      Dosage : Film Coated Tablet

      Dosage Strength : 200MG

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      Application Number :

      Registration Country : Iran

      Faran Shimi Pharmaceutical

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      02

      Faran Shimi Pharmaceutical

      Iran
      arrow
      BPI Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

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

      Contact Supplier Contact Supplier
      Flag Iran
      Virtual Booth Virtual Booth
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      Regulatory Info :

      Registration Country : Iran

      Rifaximin

      Brand Name :

      Dosage Form : Film Coated Tablet

      Dosage Strength : 550MG

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      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : Iran

      Faran Shimi Pharmaceutical

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      02

      Faran Shimi Pharmaceutical

      Iran
      arrow
      BPI Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

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

      Contact Supplier Contact Supplier
      Flag Iran
      Virtual Booth Virtual Booth
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      Packaging :

      Regulatory Info :

      Rifaximin

      Dosage : Film Coated Tablet

      Dosage Strength : 550MG

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      Approval Date :

      Application Number :

      Registration Country : Iran

      Faran Shimi Pharmaceutical

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      03

      ALFRED E TIEFENBACHER GmbH & Co KG

      Germany
      arrow
      PEGS Boston Summit
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

      Contact Supplier Contact Supplier
      Flag Germany
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Regulatory Info : EU Dossier Readiness-Q1 2020

      Registration Country : Germany

      Rifaximin

      Brand Name :

      Dosage Form : Film Coated Tablet

      Dosage Strength : 200MG

      Packaging :

      Approval Date :

      Application Number :

      Regulatory Info : EU Dossier Readiness-Q1 2020

      Registration Country : Germany

      Tiefenbacher Compnay Banner

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      03

      ALFRED E TIEFENBACHER GmbH & Co KG

      Germany
      arrow
      PEGS Boston Summit
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

      Contact Supplier Contact Supplier
      Flag Germany
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Packaging :

      Regulatory Info : EU Dossier Readiness-Q1 2020

      Rifaximin

      Dosage : Film Coated Tablet

      Dosage Strength : 200MG

      Brand Name :

      Approval Date :

      Application Number :

      Registration Country : Germany

      Tiefenbacher Compnay Banner

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      04

      ALFRED E TIEFENBACHER GmbH & Co KG

      Germany
      arrow
      PEGS Boston Summit
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

      Contact Supplier Contact Supplier
      Flag Germany
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Regulatory Info : EU Dossier Readiness-Q1 2020

      Registration Country : Germany

      Rifaximin

      Brand Name :

      Dosage Form : Film Coated Tablet

      Dosage Strength : 550MG

      Packaging :

      Approval Date :

      Application Number :

      Regulatory Info : EU Dossier Readiness-Q1 2020

      Registration Country : Germany

      Tiefenbacher Compnay Banner

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      Digital Content

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      04

      ALFRED E TIEFENBACHER GmbH & Co KG

      Germany
      arrow
      PEGS Boston Summit
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothWe are the TIEFENBACHER GROUP, Health Pioneers since 1963.

      Contact Supplier Contact Supplier
      Flag Germany
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Packaging :

      Regulatory Info : EU Dossier Readiness-Q1 2020

      Rifaximin

      Dosage : Film Coated Tablet

      Dosage Strength : 550MG

      Brand Name :

      Approval Date :

      Application Number :

      Registration Country : Germany

      Tiefenbacher Compnay Banner

      Portfolio PDF

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      05

      Pharmathen SA

      Greece
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      euroPLX 88 Lisbon
      Attending
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

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      Flag Greece
      Virtual Booth Virtual Booth
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      Regulatory Info :

      Registration Country : Greece

      Rifaximin

      Brand Name :

      Dosage Form : Tablet

      Dosage Strength : 200MG

      Packaging :

      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : Greece

      Pharmathen

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      Product Web Link

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      Digital Content

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      Corporate PDF

      05

      Pharmathen SA

      Greece
      arrow
      euroPLX 88 Lisbon
      Attending
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

      Contact Supplier Contact Supplier
      Flag Greece
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Packaging :

      Regulatory Info :

      Rifaximin

      Dosage : Tablet

      Dosage Strength : 200MG

      Brand Name :

      Approval Date :

      Application Number :

      Registration Country : Greece

      Pharmathen

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      Digital Content

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      06

      Pharmathen SA

      Greece
      arrow
      euroPLX 88 Lisbon
      Attending
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

      Contact Supplier Contact Supplier
      Flag Greece
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Regulatory Info :

      Registration Country : Greece

      Rifaximin

      Brand Name :

      Dosage Form : Tablet

      Dosage Strength : 550MG

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      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : Greece

      Pharmathen

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      Digital Content

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      06

      Pharmathen SA

      Greece
      arrow
      euroPLX 88 Lisbon
      Attending
      • fda
      • EDQM
      • WHO-GMP

      Virtual BoothPharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.

      Contact Supplier Contact Supplier
      Flag Greece
      Virtual Booth Virtual Booth
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      Packaging :

      Regulatory Info :

      Rifaximin

      Dosage : Tablet

      Dosage Strength : 550MG

      Brand Name :

      Approval Date :

      Application Number :

      Registration Country : Greece

      Pharmathen

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      07

      Cooper Pharma Limited

      India
      BPI Europe
      Not Confirmed
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      Cooper Pharma Limited

      India
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      BPI Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Flag India
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Regulatory Info :

      Registration Country : India

      Rifaximin

      Brand Name :

      Dosage Form : Tablet

      Dosage Strength : 400MG

      Packaging :

      Approval Date :

      Application Number :

      Regulatory Info :

      Registration Country : India

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      07

      Cooper Pharma Limited

      India
      BPI Europe
      Not Confirmed
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      Cooper Pharma Limited

      India
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      BPI Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Flag India
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Packaging :

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      Dosage : Tablet

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      Registration Country : India

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      08

      Intas Pharmaceuticals

      India
      PEGS Boston Summit
      Not Confirmed
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      Intas Pharmaceuticals

      India
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      PEGS Boston Summit
      Not Confirmed
      • fda
      • EDQM
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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.
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      Flag India
      Virtual Booth Virtual Booth
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      Regulatory Info :

      Registration Country : India

      Rifaximin

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      Dosage Form : Film Coated Tablet

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      08

      Intas Pharmaceuticals

      India
      PEGS Boston Summit
      Not Confirmed
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      Intas Pharmaceuticals

      India
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      PEGS Boston Summit
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Packaging :

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      Registration Country : India

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      09

      Titan Laboratories Pvt Ltd.

      India
      BPI Europe
      Not Confirmed
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      Titan Laboratories Pvt Ltd.

      India
      arrow
      BPI Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Flag India
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      Digital Content Digital Content

      Regulatory Info :

      Registration Country : India

      Rifaximin

      Brand Name :

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      Dosage Strength : 200MG

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      Application Number :

      Regulatory Info :

      Registration Country : India

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      09

      Titan Laboratories Pvt Ltd.

      India
      BPI Europe
      Not Confirmed
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      Titan Laboratories Pvt Ltd.

      India
      arrow
      BPI Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Flag India
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      Packaging :

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      Registration Country : India

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      10

      Titan Laboratories Pvt Ltd.

      India
      BPI Europe
      Not Confirmed
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      Titan Laboratories Pvt Ltd.

      India
      arrow
      BPI Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Flag India
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Regulatory Info :

      Registration Country : India

      Rifaximin

      Brand Name :

      Dosage Form : Tablet

      Dosage Strength : 550MG

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      Application Number :

      Regulatory Info :

      Registration Country : India

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      10

      Titan Laboratories Pvt Ltd.

      India
      BPI Europe
      Not Confirmed
      arrow

      Titan Laboratories Pvt Ltd.

      India
      arrow
      BPI Europe
      Not Confirmed
      • fda
      • EDQM
      • WHO-GMP
      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.
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      Flag India
      Virtual Booth Virtual Booth
      Digital Content Digital Content

      Packaging :

      Regulatory Info :

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      Registration Country : India

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      DOSAGE - TABLET;ORAL - 200MG

      USFDA APPLICATION NUMBER - 21361

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      DOSAGE - TABLET;ORAL - 550MG

      USFDA APPLICATION NUMBER - 21361

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      Italy.png
      Rifaximin (100 kg - 200 kg) API needed in Italy [ENA22523]
      A CMO that focuses on manufacturing of penicillin and cephalosporins finished formulations is looking for suppliers of Rifaximin (100 kg - 200 kg) API for commercial purposes. The supplier must support this enquiry with DMF & CoA.
      02 Apr 2025

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      02 Apr 2025

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      02 Apr 2025

      China.png
      Rifaximin API needed in China [ENA22020]
      A company that focuses on development, manufacturing and distribution of various FDFs, APIs, intermediates and medical devices is looking for suppliers of Rifaximin API for commercial purposes. The suppliers must support this enquiry with CEP or USDMF (preferred) & CoA.
      10 Feb 2025

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      10 Feb 2025

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      10 Feb 2025

      United_States_of_America.png
      Rifaximin API needed in the U.S.A [ENA21903]
      A CDMO that focuses on the development and manufacturing of various oral, liquid, and semi-solid dosage forms is looking for suppliers of Rifaximin API for development purposes. The suppliers must support this enquiry with USDMF & CoA.
      29 Jan 2025

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      29 Jan 2025

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      29 Jan 2025

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      BP Grade Rifaximin API needed in India [ENA20794]
      A company that focuses on manufacturing and exporting various finished formulations is looking for suppliers of BP Grade Rifaximin API for development purposes. The suppliers must support this enquiry with DMF & CoA.
      09 Oct 2024

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      09 Oct 2024

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      09 Oct 2024

      Canada.png
      Rifaximin (5 MT - 20 MT) API needed in Canada [ENA20515]
      A company that focuses on development and manufacturing of various finished formulations primarily in gastroenterology, neurology & dermatology is looking for suppliers of Rifaximin (5 MT - 20 MT) API for commercial purposes. The suppliers must support this enquiry with USDMF & CoA.
      11 Sep 2024

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      11 Sep 2024

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      11 Sep 2024

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      IP Grade Rifaximin (170 kg) API needed in India [ENA19892]
      A company that focuses on manufacturing and marketing of various finished formulations is looking for suppliers of IP Grade Rifaximin (170 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
      06 Jul 2024

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      06 Jul 2024

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      06 Jul 2024

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      Rifaximin (10 kg) API needed in India [ENA19696]
      A company that focuses on development and manufacturing of various tablet and capsule finished formulations is looking for suppliers of Rifaximin (10 kg) API for commercial purposes. The suppliers must support this enquiry with DMF, GMP & CoA.
      13 Jun 2024

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      13 Jun 2024

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      13 Jun 2024

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      Rifaximin (10 kg) API needed in India [ENA18686]
      A company that deals in various pharmaceutical products is looking for suppliers of Rifaximin (10 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
      25 Nov 2023

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      25 Nov 2023

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      25 Nov 2023

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      Rifaximin (5 g) API needed in India [ENA18405]
      A company that deals in various pharmaceutical products is looking for suppliers of Rifaximin (5 g) API for commercial purposes. The suppliers must support this enquiry with CoA.
      20 Oct 2023

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      20 Oct 2023

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      20 Oct 2023

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      Rifaximin (5 kg) API needed in India [ENA16992]
      A company that deals in various pharmaceutical products like injections, syrups & hygiene products is looking for suppliers of Rifaximin (5 kg) API for commercial purposes. The suppliers must support this enquiry with CoA.
      28 Apr 2023

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      28 Apr 2023

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      28 Apr 2023

      Only 10 entries up to this point, click to access all click full view read-more
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      ABOUT THIS PAGE

      Looking for 80621-81-4 / Rifaximin API manufacturers, exporters & distributors?

      Rifaximin manufacturers, exporters & distributors 1

      83

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

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

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

      API | Excipient name

      Rifaximin

      Synonyms

      Rifaxidin, Rifacol, 80621-81-4, Rifamycin l 105, Xifaxan, Rifamycin l 105sv

      Cas Number

      80621-81-4

      Unique Ingredient Identifier (UNII)

      L36O5T016N

      About Rifaximin

      A synthetic rifamycin derivative and anti-bacterial agent that is used for the treatment of GASTROENTERITIS caused by ESCHERICHIA COLI INFECTIONS. It may also be used in the treatment of HEPATIC ENCEPHALOPATHY.

      Glaxo Wellcome brand of rifaximin Manufacturers

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

      Glaxo Wellcome brand of rifaximin Suppliers

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

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

      Glaxo Wellcome brand of rifaximin USDMF

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

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

      click here to find a list of Glaxo Wellcome brand of rifaximin suppliers with USDMF on PharmaCompass.

      Glaxo Wellcome brand of rifaximin JDMF

      The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

      The Glaxo Wellcome brand of rifaximin Drug Master File in Japan (Glaxo Wellcome brand of rifaximin JDMF) empowers Glaxo Wellcome brand of rifaximin API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

      PMDA reviews the Glaxo Wellcome brand of rifaximin JDMF during the approval evaluation for pharmaceutical products. At the time of Glaxo Wellcome brand of rifaximin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

      click here to find a list of Glaxo Wellcome brand of rifaximin suppliers with JDMF on PharmaCompass.

      Glaxo Wellcome brand of rifaximin KDMF

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

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

      After submitting a Glaxo Wellcome brand of rifaximin 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 Glaxo Wellcome brand of rifaximin API can apply through the Korea Drug Master File (KDMF).

      click here to find a list of Glaxo Wellcome brand of rifaximin suppliers with KDMF on PharmaCompass.

      Glaxo Wellcome brand of rifaximin CEP

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

      A Glaxo Wellcome brand of rifaximin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Glaxo Wellcome brand of rifaximin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

      click here to find a list of Glaxo Wellcome brand of rifaximin suppliers with CEP (COS) on PharmaCompass.

      Glaxo Wellcome brand of rifaximin WC

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

      click here to find a list of Glaxo Wellcome brand of rifaximin suppliers with Written Confirmation (WC) on PharmaCompass.

      Glaxo Wellcome brand of rifaximin 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 Glaxo Wellcome brand of rifaximin as an active pharmaceutical ingredient (API).

      Finished drug products

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

      click here to find a list of Glaxo Wellcome brand of rifaximin suppliers with NDC on PharmaCompass.

      Glaxo Wellcome brand of rifaximin GMP

      Glaxo Wellcome brand of rifaximin 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 Glaxo Wellcome brand of rifaximin 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 Glaxo Wellcome brand of rifaximin GMP manufacturer or Glaxo Wellcome brand of rifaximin GMP API supplier for your needs.

      Glaxo Wellcome brand of rifaximin CoA

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

      Glaxo Wellcome brand of rifaximin CoA mostly includes findings from lab analyses of a specific batch. For each Glaxo Wellcome brand of rifaximin 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.

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