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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
DMF Review : N/A
Rev. Date :
Pay. Date :
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 |
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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 : 2022-08-07
Valid Till : 2025-06-26
Written Confirmation Number : WC-0024n
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
Available Reg Filing : ASMF |
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
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 |
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
Date of Issue : 2024-05-29
Valid Till : 2027-03-04
Written Confirmation Number : WC-0294
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35704
Submission : 2021-09-27
Status : Active
Type : II
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API Imports and Exports
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Average Price (USD/KGS) |
Number of Transactions |
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Details:
Xifaxan-Generic (rifaximin) is a rifamycin antibacterial indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults.
Lead Product(s): Rifaximin
Therapeutic Area: Gastroenterology Brand Name: Xifaxan-Generic
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 02, 2025
Lead Product(s) : Rifaximin
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zydus gets USFDA nod for generic IBS-D treatment drug
Details : Xifaxan-Generic (rifaximin) is a rifamycin antibacterial indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults.
Product Name : Xifaxan-Generic
Product Type : Antibiotic
Upfront Cash : Inapplicable
June 02, 2025
Details:
XIFAXAN (rifaximin) is a 2 week prescription treatment that provided up to 6 months of relief from IBS-D symptoms of abdominal pain and diarrhea in a clinical trial.
Lead Product(s): Rifaximin
Therapeutic Area: Gastroenterology Brand Name: Xifaxan-Generic
Study Phase: UndisclosedProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 08, 2022
Lead Product(s) : Rifaximin
Therapeutic Area : Gastroenterology
Highest Development Status : Undisclosed
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Privately Held Alvogen Announces Favorable Ruling on Patents Related to the Company’s Proposed G...
Details : XIFAXAN (rifaximin) is a 2 week prescription treatment that provided up to 6 months of relief from IBS-D symptoms of abdominal pain and diarrhea in a clinical trial.
Product Name : Xifaxan-Generic
Product Type : Antibiotic
Upfront Cash : Inapplicable
November 08, 2022
Details:
XIFAXAN (rifaximin) 200 mg tablets are indicated for travelers diarrhea. XIFAXAN (rifaximin) 550 mg tablets are indicated for reduction in risk of overt hepatic encephalopathy recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea in adults.
Lead Product(s): Rifaximin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Xifaxan-Generic
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Bausch Health
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 09, 2022
Lead Product(s) : Rifaximin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Bausch Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Bausch Health Responds to Norwich Pharmaceuticals Tentative FDA Approval for a 200 mg Rifaximin
Details : XIFAXAN (rifaximin) 200 mg tablets are indicated for travelers diarrhea. XIFAXAN (rifaximin) 550 mg tablets are indicated for reduction in risk of overt hepatic encephalopathy recurrence in adults and for the treatment of irritable bowel syndrome with di...
Product Name : Xifaxan-Generic
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 09, 2022
Details:
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Lead Product(s): Rifaximin
Therapeutic Area: Neurology Brand Name: Xifaxan
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Salix Pharmaceuticals
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 28, 2022
Lead Product(s) : Rifaximin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Salix Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Bausch Health Provides Update Following Oral Order in XIFAXAN® Patent Litigation
Details : XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Product Name : Xifaxan
Product Type : Antibiotic
Upfront Cash : Inapplicable
July 28, 2022
Details:
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Lead Product(s): Rifaximin
Therapeutic Area: Neurology Brand Name: Xifaxan
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 04, 2022
Lead Product(s) : Rifaximin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Product Name : Xifaxan
Product Type : Antibiotic
Upfront Cash : Inapplicable
July 04, 2022
Details:
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Lead Product(s): Rifaximin
Therapeutic Area: Neurology Brand Name: Xifaxan
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Bausch Health
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 20, 2022
Lead Product(s) : Rifaximin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Bausch Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Salix to Share New Data from XIFAXAN® (Rifaximin) Clinical Research at EASL's International Liver...
Details : XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Product Name : Xifaxan
Product Type : Antibiotic
Upfront Cash : Inapplicable
June 20, 2022
Details:
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Lead Product(s): Rifaximin
Therapeutic Area: Neurology Brand Name: Xifaxan
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Bausch Health
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 18, 2022
Lead Product(s) : Rifaximin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Bausch Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Salix Pharmaceuticals To Share New Data At Digestive Disease Week® 2022
Details : XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Product Name : Xifaxan
Product Type : Antibiotic
Upfront Cash : Inapplicable
May 18, 2022
Details:
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Lead Product(s): Rifaximin
Therapeutic Area: Neurology Brand Name: Xifaxan
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Bausch Health
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 25, 2021
Lead Product(s) : Rifaximin
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Bausch Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Salix Will Feature New Data At The American College Of Gastroenterology® 2021 Annual Scientific M...
Details : XIFAXAN® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
Product Name : Xifaxan
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 25, 2021
Details:
Salix going present two scientific posters featuring rifaximin data at the American Association for the Study of Liver Diseases (AASLD) annual meeting, The Liver Meeting Digital Experience, which will take place.
Lead Product(s): Rifaximin
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Xifaxan
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: Bausch Health
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 11, 2020
Lead Product(s) : Rifaximin
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Bausch Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Salix To Present Data At AASLD's The Liver Meeting Digital Experience
Details : Salix going present two scientific posters featuring rifaximin data at the American Association for the Study of Liver Diseases (AASLD) annual meeting, The Liver Meeting Digital Experience, which will take place.
Product Name : Xifaxan
Product Type : Antibiotic
Upfront Cash : Inapplicable
November 11, 2020
Details:
Company plans to start a Phase 2 trial in the first half of 2021 evaluating a novel rifaximin formulation for a potential sickle cell disease treatment.
Lead Product(s): Rifaximin
Therapeutic Area: Genetic Disease Brand Name: Xifaxan
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 29, 2020
Lead Product(s) : Rifaximin
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Bausch Health's Rifaximin Receives FDA Orphan Designation For Sickle Cell Disease
Details : Company plans to start a Phase 2 trial in the first half of 2021 evaluating a novel rifaximin formulation for a potential sickle cell disease treatment.
Product Name : Xifaxan
Product Type : Antibiotic
Upfront Cash : Inapplicable
October 29, 2020
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
Packaging :
Approval Date :
Application Number :
Regulatory Info :
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
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Iran
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 : 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
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 :
Approval Date :
Application Number :
Regulatory Info :
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 :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Greece
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 : India
Brand Name :
Dosage Form : Film Coated Tablet
Dosage Strength : 550MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
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 :
Application Number :
Regulatory Info :
Registration Country : Norway
DRUG PRODUCT COMPOSITIONS
Related Excipient Companies
Excipients by Applications
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : AceCel is suitable for majority of the directly compressible actives, combines good flow and high compressibility.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Category : Direct Compression, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Fillers, Diluents & Binders, Granulation
Excipient Details : HiCel acts as a strong & dry binder. It facilitates low tablet friability & promotes rapid tablet disintegration.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
Grade : Oral
Category : Disintegrants & Superdisintegrants, Granulation, Lubricants & Glidants
Application : Disintegrants & Superdisintegrants, Granulation, Lubricants & Glidants
Application : Fillers, Diluents & Binders, Granulation
Grade : Not Available
Category : API Stability Enhancers, Coating Systems & Additives, Controlled & Modified Release, Direct Compression, Granulation, Rheology Modifiers, Vegetarian Capsules
Application : API Stability Enhancers, Coating Systems & Additives, Controlled & Modified Release, Direct Compression, Granulation, Rheology Modifiers, Vegetarian Capsules
Excipient Details : Controlled Release, Direct Compression,Wet Granulation,Tablet Coating, Liquid Solutions and Suspensions
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Hydroxypropyl Methylcellulose
Dosage Form : Tablet
Grade : Oral
Category : Coating Systems & Additives, Fillers, Diluents & Binders, Granulation
Application : Direct Compression, Granulation
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Lactose Monohydrate
Brand Name : Microlex® MCC 101
Application : Direct Compression, Granulation
Excipient Details : Tablets made from these granules are typically easily disintegrated using conventional super disintegrates even when hard tablets are compressed.
Pharmacopoeia Ref : Monograph- USP/NF, JP/JPE
Technical Specs : Not Available
Ingredient(s) : Microcrystalline Cellulose
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ABOUT THIS PAGE
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 Rifamixin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifamixin, including repackagers and relabelers. The FDA regulates Rifamixin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifamixin 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 Rifamixin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifamixin supplier is an individual or a company that provides Rifamixin active pharmaceutical ingredient (API) or Rifamixin finished formulations upon request. The Rifamixin suppliers may include Rifamixin API manufacturers, exporters, distributors and traders.
click here to find a list of Rifamixin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifamixin DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifamixin active pharmaceutical ingredient (API) in detail. Different forms of Rifamixin DMFs exist exist since differing nations have different regulations, such as Rifamixin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifamixin DMF submitted to regulatory agencies in the US is known as a USDMF. Rifamixin USDMF includes data on Rifamixin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifamixin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifamixin suppliers with USDMF on PharmaCompass.
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 Rifamixin Drug Master File in Japan (Rifamixin JDMF) empowers Rifamixin 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 Rifamixin JDMF during the approval evaluation for pharmaceutical products. At the time of Rifamixin 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 Rifamixin suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Rifamixin Drug Master File in Korea (Rifamixin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Rifamixin. The MFDS reviews the Rifamixin KDMF as part of the drug registration process and uses the information provided in the Rifamixin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Rifamixin 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 Rifamixin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Rifamixin suppliers with KDMF on PharmaCompass.
A Rifamixin CEP of the European Pharmacopoeia monograph is often referred to as a Rifamixin Certificate of Suitability (COS). The purpose of a Rifamixin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Rifamixin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Rifamixin to their clients by showing that a Rifamixin CEP has been issued for it. The manufacturer submits a Rifamixin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Rifamixin CEP holder for the record. Additionally, the data presented in the Rifamixin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Rifamixin DMF.
A Rifamixin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Rifamixin 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 Rifamixin suppliers with CEP (COS) on PharmaCompass.
A Rifamixin written confirmation (Rifamixin WC) is an official document issued by a regulatory agency to a Rifamixin manufacturer, verifying that the manufacturing facility of a Rifamixin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Rifamixin APIs or Rifamixin finished pharmaceutical products to another nation, regulatory agencies frequently require a Rifamixin WC (written confirmation) as part of the regulatory process.
click here to find a list of Rifamixin 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 Rifamixin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifamixin 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 Rifamixin 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 Rifamixin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifamixin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifamixin suppliers with NDC on PharmaCompass.
Rifamixin 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 Rifamixin 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 Rifamixin GMP manufacturer or Rifamixin GMP API supplier for your needs.
A Rifamixin CoA (Certificate of Analysis) is a formal document that attests to Rifamixin's compliance with Rifamixin specifications and serves as a tool for batch-level quality control.
Rifamixin CoA mostly includes findings from lab analyses of a specific batch. For each Rifamixin 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.
Rifamixin may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifamixin EP), Rifamixin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifamixin USP).