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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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AP","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1751221800,"product":"BATCH NO: 2580001421 TO 422, 2580001955TO 957 CAS NO. 80621-81-4 ACTIVE PHARMACEUTICAL INGREDIENTS RIFAXIMIN","address":"UNIT NO. 3B - 38, 39 AND 40,,3RD F","city":"LBS MARG KURLA WEST,MAHARASHTRA","supplier":"OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVA","supplierCountry":"INDIA","foreign_port":"GENOA","customer":"UNDISCLOSED","customerCountry":"ITALY","quantity":"5006.32","actualQuantity":"5006.32","unit":"KGS","unitRateFc":"218","totalValueFC":"1238612.2","currency":"EURO","unitRateINR":21258.782778567893,"date":"30-Jun-2025","totalValueINR":"106428269.4","totalValueInUsd":"1238612.2","indian_port":"JNPT","hs_no":"29419090","bill_no":"3176291","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"UNIT NO. 3B - 38, 39 AND 40,,3RD F, LBS MARG KURLA WEST,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751567400,"product":"PHARMACEUTICAL RAW MATERIALS: RIFAXIMINBP(BATCH NO.4\/OT-RFX-A1-056\/25 DT-07-06-2025 & 4\/OT-RFX-A1-079\/24 DT-03-01-2025)","address":"4TH FLOOR,UNIT NO. 414,ATLANTIS,?\\r\\n\t\t\t\t\tSARABHAI COMPOUND,VADIWADI,?\\r\\n\t\t\t\t\t\t390007","city":"N\/A","supplier":"DUCHEM INDIA","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"UNDISCLOSED","customerCountry":"BANGLADESH","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"180","totalValueFC":"26273.1","currency":"USD","unitRateINR":15074.799999999999,"date":"04-Jul-2025","totalValueINR":"2261220","totalValueInUsd":"26273.1","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"3296907","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"4TH FLOOR,UNIT NO. 414,ATLANTIS,?\\r\\n\t\t\t\t\tSARABHAI COMPOUND,VADIWADI,?\\r\\n\t\t\t\t\t\t390007, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751653800,"product":"PHARMACEUTICAL RAW MATERIALS: RIFAXIMINBP(BATCH NO.4\/OT-RFX-A1-056\/25 DT-07-06-2025 & 4\/OT-RFX-A1-079\/24 DT-03-01-2025)","address":"4TH FLOOR,UNIT NO. 414,ATLANTIS,?\\r\\n\t\t\t\t\tSARABHAI COMPOUND,VADIWADI,?\\r\\n\t\t\t\t\t\t390007","city":"N\/A","supplier":"DUCHEM INDIA","supplierCountry":"INDIA","foreign_port":"DHAKA","customer":"UNDISCLOSED","customerCountry":"BANGLADESH","quantity":"150.00","actualQuantity":"150","unit":"KGS","unitRateFc":"180","totalValueFC":"26273.1","currency":"USD","unitRateINR":15074.799999999999,"date":"05-Jul-2025","totalValueINR":"2261220","totalValueInUsd":"26273.1","indian_port":"Bombay Air","hs_no":"29419090","bill_no":"3310508","productDescription":"API","marketType":"","country":"BANGLADESH","selfForZScoreResived":"Pharma Grade","supplierPort":"Bombay Air","supplierAddress":"4TH FLOOR,UNIT NO. 414,ATLANTIS,?\\r\\n\t\t\t\t\tSARABHAI COMPOUND,VADIWADI,?\\r\\n\t\t\t\t\t\t390007, N\/A","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751999400,"product":"BT NO:2580001959 TO 1960,2580002464 TO 465,2580002417 CAS NO. 80621-81-4 ACTIVEPHARMACEUTICAL INGREDIENTS RIFAXIMIN","address":"UNIT NO. 3B - 38, 39 AND 40,,3RD F","city":"LBS MARG KURLA WEST,MAHARASHTRA","supplier":"OLON ACTIVE PHARMACEUTICAL INGREDIENTS INDIA PRIVA","supplierCountry":"INDIA","foreign_port":"GENOA","customer":"UNDISCLOSED","customerCountry":"ITALY","quantity":"5107.30","actualQuantity":"5107.3","unit":"KGS","unitRateFc":"218","totalValueFC":"1277806.4","currency":"EURO","unitRateINR":21533.019677716209,"date":"09-Jul-2025","totalValueINR":"109975591.4","totalValueInUsd":"1277806.4","indian_port":"JNPT","hs_no":"29419090","bill_no":"3423543","productDescription":"API","marketType":"REGULATED MARKET","country":"ITALY","selfForZScoreResived":"Pharma Grade","supplierPort":"JNPT","supplierAddress":"UNIT NO. 3B - 38, 39 AND 40,,3RD F, LBS MARG KURLA WEST,MAHARASHTRA","customerAddress":""},{"dataSource":"API Export","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1752517800,"product":"RIFAXIMIN","address":"PLOT NO.131,3RD FLOOR,NARMADA","city":"HYDERABAD. 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    05-Jan-2022
    26-Jul-2025
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    DRUG PRODUCT COMPOSITIONS

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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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    ABOUT THIS PAGE

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

    Rifaximin manufacturers, exporters & distributors 1

    82

    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.

    Flonorm Manufacturers

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

    Flonorm Suppliers

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

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

    Flonorm USDMF

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

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

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

    Flonorm 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 Flonorm Drug Master File in Japan (Flonorm JDMF) empowers Flonorm 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 Flonorm JDMF during the approval evaluation for pharmaceutical products. At the time of Flonorm 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 Flonorm suppliers with JDMF on PharmaCompass.

    Flonorm KDMF

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

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

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

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

    Flonorm CEP

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

    A Flonorm CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Flonorm 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 Flonorm suppliers with CEP (COS) on PharmaCompass.

    Flonorm WC

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

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

    Flonorm 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 Flonorm as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Flonorm GMP

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

    Flonorm CoA

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

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

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