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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
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
Molecular Weight | 785.9 g/mol |
---|---|
Molecular Formula | C43H51N3O11 |
XLogP3 | 6.9 |
Hydrogen Bond Donor Count | 5 |
Hydrogen Bond Acceptor Count | 12 |
Rotatable Bond Count | 3 |
Exact Mass | 785.35235945 g/mol |
Monoisotopic Mass | 785.35235945 g/mol |
Topological Polar Surface Area | 198 Ų |
Heavy Atom Count | 57 |
Formal Charge | 0 |
Complexity | 1590 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 9 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 3 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Xifaxan |
PubMed Health | Rifaximin (By mouth) |
Drug Classes | Antibiotic |
Drug Label | XIFAXAN 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 Ingredient | Rifaximin |
Dosage Form | Tablet |
Route | Oral |
Strength | 200mg; 550mg |
Market Status | Prescription |
Company | Salix Pharms |
2 of 2 | |
---|---|
Drug Name | Xifaxan |
PubMed Health | Rifaximin (By mouth) |
Drug Classes | Antibiotic |
Drug Label | XIFAXAN 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 Ingredient | Rifaximin |
Dosage Form | Tablet |
Route | Oral |
Strength | 200mg; 550mg |
Market Status | Prescription |
Company | Salix Pharms |
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
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.
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.)
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
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
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.
Approximately 6 hours.
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.
GDUFA
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DMF Number : 17150
Submission : 2004-02-10
Status : Active
Type : II
Registration Number : 226MF10147
Registrant's Address : Via Angelo Titi, 22/26, Zona ex punto franco, 72100 Brindisi, Italy
Initial Date of Registration : 2014-09-01
Latest Date of Registration :
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-05-04
Registration Number : 20220504-209-J-1285
Manufacturer Name : EUROAPI ITALY SRL
Manufacturer Address : Via Angelo TiTi, 22/26 - 72100 Brindisi (BR)
Available Reg Filing : ASMF |
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Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
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DMF Number : 36125
Submission : 2021-08-29
Status : Active
Type : II
Certificate Number : CEP 2012-146 - Rev 02
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 2362
Status : Valid
Date of Issue : 2022-07-08
Valid Till : 2025-06-28
Written Confirmation Number : WC-0024
Address of the Firm :
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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DMF Number : 38843
Submission : 2024-03-07
Status : Active
Type : II
Certificate Number : CEP 2021-377 - Rev 01
Issue Date : 2024-06-10
Type : Chemical
Substance Number : 2362
Status : Valid
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
Available Reg Filing : ASMF |
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Rev. Date :
Pay. Date :
DMF Number : 35704
Submission : 2021-09-27
Status : Active
Type : II
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DMF Review : Reviewed
Rev. Date : 2015-03-27
Pay. Date : 2014-12-12
DMF Number : 28906
Submission : 2015-02-03
Status : Active
Type : II
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DMF Review : Reviewed
Rev. Date : 2020-09-14
Pay. Date : 2020-07-30
DMF Number : 34387
Submission : 2020-06-08
Status : Active
Type : II
Certificate Number : R0-CEP 2020-303 - Rev 01
Issue Date : 2022-06-29
Type : Chemical
Substance Number : 2362
Status : Valid
Date of Issue : 2022-11-03
Valid Till : 2025-07-02
Written Confirmation Number : WC-0182
Address of the Firm :
NDC Package Code : 59285-008
Start Marketing Date : 2015-05-11
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-01-20
Registration Number : 20220120-209-J-1217
Manufacturer Name : Optimus Drugs Private Limited
Manufacturer Address : Unit-I, Survey No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvanagiri District – 508 284, Telangana, India
Registration Number : 226MF10147
Registrant's Address : Via Angelo Titi, 22/26, Zona ex punto franco, 72100 Brindisi, Italy
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2014-09-01
Registration Number : 226MF10165
Registrant's Address : Viale Milano 26 36075 Montecchio Maggiore Vicenza, Italy
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2016-05-06
Registration Number : 306MF10031
Registrant's Address : Strada Rivoltana Km 6/7 20053 Rodano Milano Italy
Initial Date of Registration : 2024-02-21
Latest Date of Registration : 2025-02-07
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2022-05-04
Registration Number : 20220504-209-J-1285
Manufacturer Name : EUROAPI ITALY SRL
Manufacturer Address : Via Angelo TiTi, 22/26 - 72100 Brindisi (BR)
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2022-06-13
Registration Number : 20220613-209-J-1259
Manufacturer Name : Cadchem Laboratories Limited
Manufacturer Address : VPO Jaula Khurd. Tehsil Dera Bassi, District Ajitgarh (Mohali), Punjab, India
Registrant Name : Chong Kun Dang Bio Co., Ltd.
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Registration Number : 20220701-209-J-1323
Manufacturer Name : Chong Kun Dang Bio Co., Ltd.
Manufacturer Address : 292 Sinwon-ro, Danwon-gu, Ansan-si, Gyeonggi-do.
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Manufacturer Name : FIS Fabbrica Italiana Sintet...
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Registration Number : 20250228-209-J-1772
Manufacturer Name : Luohe Chief Pharmaceutical C...
Manufacturer Address : No.168, Longjiang Road, Yancheng District, Luohe City, Henan Province, 462300 PR Chin...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-02-15
Registration Number : 20230215-209-J-1419
Manufacturer Name : Olon SpA
Manufacturer Address : Via Della Vittoria, 89 - 26837 Mulazzano (LO), Italy
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2022-01-20
Registration Number : 20220120-209-J-1217
Manufacturer Name : Optimus Drugs Private Limite...
Manufacturer Address : Unit-I, Survey No. 239 & 240, Dothigudem Village, Pochampally Mandal, Yadadri-Bhuvana...
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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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Registration Country : Iran
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Dosage Form : Film Coated Tablet
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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
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Regulatory Info : EU Dossier Readiness-Q1 2020
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Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
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Dosage Form : Film Coated Tablet
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Regulatory Info : EU Dossier Readiness-Q1 2020
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Regulatory Info : EU Dossier Readiness-Q1 2020
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Regulatory Info : EU Dossier Readiness-Q1 2020
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Registration Country : Germany
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Dosage Form : Film Coated Tablet
Dosage Strength : 550MG
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Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
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Registration Country : Greece
Brand Name :
Dosage Form : Tablet
Dosage Strength : 200MG
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Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
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Registration Country : Greece
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Dosage Form : Tablet
Dosage Strength : 550MG
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Regulatory Info :
Registration Country : Norway
Brand Name : Xifaxan
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 550 mg
Packaging : Blister
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Registration Country : Norway
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Dosage Form : Film Coated Tablet
Dosage Strength : 550MG
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Registration Country : Turkey
RLD :
TE Code :
Brand Name : RIFAXIMIN
Dosage Form : TABLET;ORAL
Dosage Strength : 200MG
Approval Date :
Application Number : 214370
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : RIFAXIMIN
Dosage Form : TABLET;ORAL
Dosage Strength : 550MG
Approval Date :
Application Number : 214369
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
RLD :
TE Code :
Brand Name : XIFAXAN
Dosage Form : TABLET;ORAL
Dosage Strength : 550MG
Approval Date :
Application Number : 22554
RX/OTC/DISCN :
RLD :
TE Code :
RLD :
TE Code :
Brand Name : RIFAXIMIN
Dosage Form : TABLET;ORAL
Dosage Strength : 550MG
Approval Date :
Application Number : 213713
RX/OTC/DISCN :
RLD :
TE Code :
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
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
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
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
Regulatory Info :
Registration Country : Sweden
Brand Name : Tixteller
Dosage Form : FILM COATED PILL
Dosage Strength : 550 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
Brand Name : Normix
Dosage Form : Rifaximin 200Mg 12 Combined Oral Use
Dosage Strength : 12 cpr riv 200 mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Brand Name : Normix
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
Regulatory Info :
Registration Country : Switzerland
Brand Name : Xifaxan
Dosage Form : Film-Coated Tablets
Dosage Strength : 550mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Sweden
Brand Name : Xifaxan
Dosage Form : FILM COATED PILL
Dosage Strength : 550 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Brand Name : Xifaxan
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 550 mg
Packaging : Blister
Approval Date :
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Registration Country : Norway
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : ZAXINE
Dosage Form : TABLET
Dosage Strength : 550MG
Packaging : 60
Approval Date :
Application Number : 2410702
Regulatory Info : Prescription
Registration Country : Canada
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Registration Country : Australia
Brand Name : Xifaxan
Dosage Form :
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Packaging : 56
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Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : XIFAXAN
Dosage Form : FCT
Dosage Strength : 550mg
Packaging : 56X1mg
Approval Date :
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Regulatory Info : Originator
Registration Country : South Africa
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Regulatory Info :
Registration Country : Iran
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 200MG
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Registration Country : Iran
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Packaging :
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Dosage : Film Coated Tablet
Dosage Strength : 200MG
Brand Name :
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Registration Country : Iran
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Regulatory Info :
Registration Country : Iran
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 550MG
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Registration Country : Iran
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Packaging :
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Dosage : Film Coated Tablet
Dosage Strength : 550MG
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Registration Country : Iran
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 200MG
Packaging :
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Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Packaging :
Regulatory Info : EU Dossier Readiness-Q1 2020
Dosage : Film Coated Tablet
Dosage Strength : 200MG
Brand Name :
Approval Date :
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Registration Country : Germany
Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 550MG
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Regulatory Info : EU Dossier Readiness-Q1 2020
Registration Country : Germany
Packaging :
Regulatory Info : EU Dossier Readiness-Q1 2020
Dosage : Film Coated Tablet
Dosage Strength : 550MG
Brand Name :
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Registration Country : Germany
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
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Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
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Dosage : Tablet
Dosage Strength : 200MG
Brand Name :
Approval Date :
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Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Regulatory Info :
Registration Country : Greece
Brand Name :
Dosage Form : Tablet
Dosage Strength : 550MG
Packaging :
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Regulatory Info :
Registration Country : Greece
Pharmathen provides life cycle Management solutions for branded pharma, as well as to develop & establish new technology platforms.
Packaging :
Regulatory Info :
Dosage : Tablet
Dosage Strength : 550MG
Brand Name :
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Registration Country : Greece
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 200MG
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Registration Country : India
Packaging :
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Dosage : Film Coated Tablet
Dosage Strength : 200MG
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Registration Country : India
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Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 100MG
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Registration Country : India
Packaging :
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Dosage : Tablet
Dosage Strength : 100MG
Brand Name :
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Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 200MG
Packaging :
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Registration Country : India
Packaging :
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Dosage : Tablet
Dosage Strength : 200MG
Brand Name :
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Registration Country : India
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Tablet
Dosage Strength : 200MG
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Registration Country : India
Packaging :
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Dosage : Tablet
Dosage Strength : 200MG
Brand Name :
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Registration Country : India
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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.
A Xifaxan, Rifacol, Fatroximin, Rifaximin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Xifaxan, Rifacol, Fatroximin, Rifaximin, including repackagers and relabelers. The FDA regulates Xifaxan, Rifacol, Fatroximin, Rifaximin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Xifaxan, Rifacol, Fatroximin, 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 Xifaxan, Rifacol, Fatroximin, Rifaximin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Xifaxan, Rifacol, Fatroximin, Rifaximin supplier is an individual or a company that provides Xifaxan, Rifacol, Fatroximin, Rifaximin active pharmaceutical ingredient (API) or Xifaxan, Rifacol, Fatroximin, Rifaximin finished formulations upon request. The Xifaxan, Rifacol, Fatroximin, Rifaximin suppliers may include Xifaxan, Rifacol, Fatroximin, Rifaximin API manufacturers, exporters, distributors and traders.
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A Xifaxan, Rifacol, Fatroximin, Rifaximin DMF (Drug Master File) is a document detailing the whole manufacturing process of Xifaxan, Rifacol, Fatroximin, Rifaximin active pharmaceutical ingredient (API) in detail. Different forms of Xifaxan, Rifacol, Fatroximin, Rifaximin DMFs exist exist since differing nations have different regulations, such as Xifaxan, Rifacol, Fatroximin, Rifaximin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Xifaxan, Rifacol, Fatroximin, Rifaximin DMF submitted to regulatory agencies in the US is known as a USDMF. Xifaxan, Rifacol, Fatroximin, Rifaximin USDMF includes data on Xifaxan, Rifacol, Fatroximin, Rifaximin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Xifaxan, Rifacol, Fatroximin, Rifaximin USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 Xifaxan, Rifacol, Fatroximin, Rifaximin Drug Master File in Japan (Xifaxan, Rifacol, Fatroximin, Rifaximin JDMF) empowers Xifaxan, Rifacol, Fatroximin, 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 Xifaxan, Rifacol, Fatroximin, Rifaximin JDMF during the approval evaluation for pharmaceutical products. At the time of Xifaxan, Rifacol, Fatroximin, Rifaximin JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Xifaxan, Rifacol, Fatroximin, Rifaximin Drug Master File in Korea (Xifaxan, Rifacol, Fatroximin, Rifaximin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Xifaxan, Rifacol, Fatroximin, Rifaximin. The MFDS reviews the Xifaxan, Rifacol, Fatroximin, Rifaximin KDMF as part of the drug registration process and uses the information provided in the Xifaxan, Rifacol, Fatroximin, Rifaximin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Xifaxan, Rifacol, Fatroximin, 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 Xifaxan, Rifacol, Fatroximin, Rifaximin API can apply through the Korea Drug Master File (KDMF).
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A Xifaxan, Rifacol, Fatroximin, Rifaximin CEP of the European Pharmacopoeia monograph is often referred to as a Xifaxan, Rifacol, Fatroximin, Rifaximin Certificate of Suitability (COS). The purpose of a Xifaxan, Rifacol, Fatroximin, Rifaximin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Xifaxan, Rifacol, Fatroximin, Rifaximin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Xifaxan, Rifacol, Fatroximin, Rifaximin to their clients by showing that a Xifaxan, Rifacol, Fatroximin, Rifaximin CEP has been issued for it. The manufacturer submits a Xifaxan, Rifacol, Fatroximin, Rifaximin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Xifaxan, Rifacol, Fatroximin, Rifaximin CEP holder for the record. Additionally, the data presented in the Xifaxan, Rifacol, Fatroximin, Rifaximin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Xifaxan, Rifacol, Fatroximin, Rifaximin DMF.
A Xifaxan, Rifacol, Fatroximin, Rifaximin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Xifaxan, Rifacol, Fatroximin, Rifaximin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A Xifaxan, Rifacol, Fatroximin, Rifaximin written confirmation (Xifaxan, Rifacol, Fatroximin, Rifaximin WC) is an official document issued by a regulatory agency to a Xifaxan, Rifacol, Fatroximin, Rifaximin manufacturer, verifying that the manufacturing facility of a Xifaxan, Rifacol, Fatroximin, Rifaximin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Xifaxan, Rifacol, Fatroximin, Rifaximin APIs or Xifaxan, Rifacol, Fatroximin, Rifaximin finished pharmaceutical products to another nation, regulatory agencies frequently require a Xifaxan, Rifacol, Fatroximin, Rifaximin WC (written confirmation) as part of the regulatory process.
click here to find a list of Xifaxan, Rifacol, Fatroximin, Rifaximin suppliers with Written Confirmation (WC) on PharmaCompass.
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 Xifaxan, Rifacol, Fatroximin, Rifaximin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Xifaxan, Rifacol, Fatroximin, Rifaximin API and other APIs are published in this directory by the FDA.
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 Xifaxan, Rifacol, Fatroximin, 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.
The NDC directory also contains data on finished compounded human drug products that contain Xifaxan, Rifacol, Fatroximin, Rifaximin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Xifaxan, Rifacol, Fatroximin, Rifaximin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Xifaxan, Rifacol, Fatroximin, Rifaximin suppliers with NDC on PharmaCompass.
Xifaxan, Rifacol, Fatroximin, 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 Xifaxan, Rifacol, Fatroximin, 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 Xifaxan, Rifacol, Fatroximin, Rifaximin GMP manufacturer or Xifaxan, Rifacol, Fatroximin, Rifaximin GMP API supplier for your needs.
A Xifaxan, Rifacol, Fatroximin, Rifaximin CoA (Certificate of Analysis) is a formal document that attests to Xifaxan, Rifacol, Fatroximin, Rifaximin's compliance with Xifaxan, Rifacol, Fatroximin, Rifaximin specifications and serves as a tool for batch-level quality control.
Xifaxan, Rifacol, Fatroximin, Rifaximin CoA mostly includes findings from lab analyses of a specific batch. For each Xifaxan, Rifacol, Fatroximin, 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.
Xifaxan, Rifacol, Fatroximin, Rifaximin may be tested according to a variety of international standards, such as European Pharmacopoeia (Xifaxan, Rifacol, Fatroximin, Rifaximin EP), Xifaxan, Rifacol, Fatroximin, Rifaximin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Xifaxan, Rifacol, Fatroximin, Rifaximin USP).