Synopsis
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1. Rifamycins
2. Rifomycin
3. Rifomycins
1. Rifamycin Sv
2. Rifocin
3. Rifamicine Sv
4. Rifomycin Sv
5. Rifamicina
6. Rifamycine
7. Rifamycinum
8. Rifocyn
9. 6998-60-3
10. Cb-01-11
11. Aemcolo
12. Du69t8zzpa
13. M-14
14. Chebi:29673
15. 6998-60-3 (free Acid)
16. 15105-92-7
17. Rifamycin Sv, An Antibiotic Produced By Certain Strains Of Streptomyces Mediterranei, Or The Same Substance Produced By Any Other Means
18. Rifamycine [inn-french]
19. Rifamycinum [inn-latin]
20. Rifamicina [inn-spanish]
21. (7s,9e,11s,12r,13s,14r,15r,16r,17s,18s,19e,21z)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(28),2,4,9,19,21,25(29),26-octaen-13-yl Acetate
22. [(7s,9e,11s,12r,13s,14r,15r,16r,17s,18s,19e,21z)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.14,7.05,28]triaconta-1(29),2,4,9,19,21,25,27-octaen-13-yl] Acetate
23. Rifomycin
24. Einecs 230-273-3
25. Unii-du69t8zzpa
26. Tuborin
27. Rifamycin-sv
28. Nsc133100
29. Rifamycin [usan:inn:ban:dcf]
30. Rifamycin [inn]
31. Rifamycin (usan/inn)
32. Rifamycin [usan]
33. Rifamycin Sv [mi]
34. Rifamycin [who-dd]
35. Schembl151824
36. Chembl437765
37. Gtpl4570
38. Dtxsid1032014
39. Rifamycin Sv [ep Impurity]
40. Bdbm50391000
41. Lmpk05000005
42. Akos024281286
43. Zinc169633673
44. Db11753
45. 2,7-(epoxypentadeca(1,11,13)trienimino)naphtho(2,1-b)furan-1,11(2h)-dione, 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-, 21-acetate
46. Rifaximin Impurity C [ep Impurity]
47. D02549
48. Sr-01000872597
49. Sr-01000872597-1
50. (pentahydroxy-methoxy-heptamethyl-dioxo-[?]yl) Acetate
51. Q26270990
52. (2s,12z,14e,16s,17s,18r,19r,20r,21s,22r,23s,24e)-5,6,9,17,19-pentahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-1,11-dioxo-1,2-dihydro-2,7-(epoxypentadeca[1,11,13]trienoimino)naphtho[2,1-b]furan-21-yl Acetate
53. (7s,11s,12r,13s,14r,15r,16r,17s,18s,19z,21z)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.1^{4,7}.0^{5,28}]triaconta-1,3,5(28),9,19,21,25(29),26-octaen-13-yl Acetate
54. (7s,11s,13s,17s,18s,12r,14r,15r,16r)-2,15,17,27,29-pentahydroxy-11-methoxy-3,7 ,12,14,16,18,22-heptamethyl-6,23-dioxo-8,30-dioxa-24-azatetracyclo[23.3.1.1<4, 7>.0<5,28>]triaconta-1(28),2,4,9,19,21,25(29),26-octaen-13-yl Acetate
55. 2,7-(epoxy[1,11,13]pentadecatrienoimino)naphtho[2,1-b]furan-1,11(2h)-dione, 21-(acetyloxy)-5,6,9,17,19-pentahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-, (2s,16s,17s,18r,19r,20r,21s,22r,23s)-
56. 5,6,9,17,19,21-hexahydroxy-23-methoxy-2,4,12,16,18,20,22-heptamethyl-2,7-(epoxypentadeca(1,11,13)trienimino)naphtho(2,1-b)furan-1,11(2h)-dione 21-acetate
| Molecular Weight | 697.8 g/mol |
|---|---|
| Molecular Formula | C37H47NO12 |
| XLogP3 | 4.9 |
| Hydrogen Bond Donor Count | 6 |
| Hydrogen Bond Acceptor Count | 12 |
| Rotatable Bond Count | 3 |
| Exact Mass | 697.30982593 g/mol |
| Monoisotopic Mass | 697.30982593 g/mol |
| Topological Polar Surface Area | 201 Ų |
| Heavy Atom Count | 50 |
| Formal Charge | 0 |
| Complexity | 1330 |
| 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 |
Rifamycin is indicated for the treatment of adult patients with travelers' diarrhea caused by noninvasive strains of _E. coli_. The status of the disease should not be complicated by fever or blood in the stool. To prevent drug-resistant bacteria, it is important to mention that the use of rifamycin for this indication should be only done in cases where the infection is proven or strongly suspected to be caused by bacteria. Travallers' diarrhea is very common problem affecting 20-60% of the travellers and it is defined as an increase in frequency of bowel movements to three or more loose stools per day during a trip abroad. This condition is rarely life threatening but in severe cases it can produce dehydration and sepsis. The most common cause of travellers' diarrhea is a pathogen and from the pathogens identified, bacteria is the most common cause followed by norovirus, rotavirus and similar viruses.
FDA Label
Treatment of acute infectious diarrhoea
Treatment of acute infectious diarrhoea
Rifamycin is known to be effective against Gram-positive and Gram-negative pathogens and mycobacteria. It is very effective against _E. coli_ reporting a MIC90 of 64-128 mcg/ml without showing cross-resistance with other antimicrobial agents. The specific indication of rifamycin is extremely important as ther were previous reports that indicated a high risk factor in the generation of resistant _E. coli_ strains in patients with inflammatory bowel disease. In clinical trials, rifamycin was tested in a randomized clinical trial of travellers' coming from Mexico and Guatemala. In this trial, rifamycin was proven to significantly reduce the symptoms of travellers' diarrhea.
Anti-Bacterial Agents
Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)
J04AB03
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
A07AA13 - Rifamycin
D - Dermatologicals
D06 - Antibiotics and chemotherapeutics for dermatological use
D06A - Antibiotics for topical use
D06AX - Other antibiotics for topical use
D06AX15 - Rifamycin
J - Antiinfectives for systemic use
J04 - Antimycobacterials
J04A - Drugs for treatment of tuberculosis
J04AB - Antibiotics
J04AB03 - Rifamycin
S - Sensory organs
S01 - Ophthalmologicals
S01A - Antiinfectives
S01AA - Antibiotics
S01AA16 - Rifamycin
S - Sensory organs
S02 - Otologicals
S02A - Antiinfectives
S02AA - Antiinfectives
S02AA12 - Rifamycin
Absorption
Rifamycin has a very poor absorption and thus, the generation of an oral modified-release formulation using the technology of the multi-matrix structure was required for the generation of the FDA approved product. This preparation allows the delivery of the active ingredient in the distal small bowel and colon without interfering with the flora in the upper gastrointestinal tract. The multi-matrix is made by a lipophiic matrix surrounded in a hydrophilic matrix which allows for the protection of the active ingredient from dissolution in the intestinal aqueous fluids before it arrives in the cecum. All this matrix is surrounded by a gastro-resistant polymer that only desintegrate in a pH lower than 7. All this administration-customed formulation allows for a bioavailability of <0.1% and the plasma concentrations are reported to be of <2 ng/ml in patients receiving a dose of 400 mg. This confirms that the site of action of rifamycin stays in the small intestine and colon which prevents the need for dose adjustments in special populations as well as systemic drug interactions. The reported Cmax, tmax, AUC and mean residence time after a dosage of 250 mg of rifamycin is 36 mg/L, 5 min, 11.84 mg.h/L and 0.49 h respectively.
Route of Elimination
From the administered dose, 18%, 50% and 21% is recovered in feces during the first 24, 48 and 72h after administration. This will represent about 90% of the administered dose eliminated by the feces while the urinary secretion is negligible.
Volume of Distribution
The reported volume of distribution after measured after a dosage of 250 mg of rifamycin is 101.8 L.
Clearance
The reported clearance when a dose of 250 mg of rifamycin was administered is 23.3 L/h.
When absorbed, rifamycin is mainly metabolzied in hepatocytes and intestinal microsomes to a 25-deacetyl metabolite.
The reported half-life when a dose of 250 mg of rifamycin was administered is 3 h.
Rifamycins, as well as all the other members of this group, present an antibacterial mechanism of action related to the inhibition of RNA synthesis. This mechanism of action is done by the strong binding to the DNA-dependent RNA polymerase of prokaryotes. The inhibition of the RNA synthesis is thought to be related with the initiation phase of the process and to involve stacking interactions between the naphthalene ring and the aromatic moiety in the polymerase. As well, it has been suggested that the presence of zinc atoms in the polymerase allows for the binding of phenolic -OH groups of the naphthalene ring. In eukaryotic cells, the binding is significantly reduced making them at least 100 to 10,000 times less sensitive to the action of rifamycins. The members of the rifamycin family present the same mechanism of action and the structural modifications are usually related to pharmacokinetic properties as well as to the interaction with eukaryotic cells.
API SUPPLIERS
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26159
Submission : 2012-06-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35703
Submission : 2021-07-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28546
Submission : 2014-07-25
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35707
Submission : 2021-08-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22325
Submission : 2008-12-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11291
Submission : 1995-01-09
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32722
Submission : 2018-05-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32708
Submission : 2018-05-07
Status : Active
Type : II
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Drugs in Development
Details:
Through termination of the License Agreement, Redhill will regain the rights of Aemcolo (Rifamycin), which is indicated for travelers’ diarrhea caused by noninvasive strains of E.coli in adults.
Lead Product(s): Rifamycin,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Aemcolo
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: RedHill Biopharma
Deal Size: $36.3 million Upfront Cash: $12.0 million
Deal Type: Termination July 09, 2024
Lead Product(s) : Rifamycin,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : RedHill Biopharma
Deal Size : $36.3 million
Deal Type : Termination
RedHill Biopharma Terminates License Agreement for Aemcolo®
Details : Through termination of the License Agreement, Redhill will regain the rights of Aemcolo (Rifamycin), which is indicated for travelers’ diarrhea caused by noninvasive strains of E.coli in adults.
Product Name : Aemcolo
Product Type : Antibiotic
Upfront Cash : $12.0 million
July 09, 2024
Details:
The trial investigated the efficacy and safety of two doses of Rifamycin SV-MMX 600mg against placebo after a 2-week course of treatment followed by a 3 months follow-up.
Lead Product(s): Rifamycin,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Aemcolo
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: RedHill Biopharma
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 11, 2021
Lead Product(s) : Rifamycin,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : RedHill Biopharma
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The trial investigated the efficacy and safety of two doses of Rifamycin SV-MMX 600mg against placebo after a 2-week course of treatment followed by a 3 months follow-up.
Product Name : Aemcolo
Product Type : Antibiotic
Upfront Cash : Inapplicable
January 11, 2021
Details:
Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Diarrhea.
Lead Product(s): Rifamycin,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 22, 2019
Lead Product(s) : Rifamycin,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Diarrhea.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
July 22, 2019
Details:
Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Dysentery.
Lead Product(s): Rifamycin,Inapplicable
Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 27, 2018
Lead Product(s) : Rifamycin,Inapplicable
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea
Details : Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Dysentery.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
February 27, 2018
Details:
Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Irritable Bowel Syndrome.
Lead Product(s): Rifamycin,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 04, 2017
Lead Product(s) : Rifamycin,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Rifamycin SV-MMX® 600 mg Tablets Administered Three or Two Times Daily to Patients With IBS-D
Details : Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Irritable Bowel Syndrome.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
April 04, 2017
Details:
Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Rifamycin,Inapplicable
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 21, 2016
Lead Product(s) : Rifamycin,Inapplicable
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Pharmacokinetics and Safety Study of Rifamycin SV-MMX® 600 mg Tablets After Single and Multiple...
Details : Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of undefined medical condition.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
November 21, 2016
Details:
Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Diverticulitis.
Lead Product(s): Rifamycin,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 07, 2013
Lead Product(s) : Rifamycin,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Rifamycin SV-MMX® 400 mg b.i.d. vs. Rifamycin SV-MMX® 600 mg t.i.d. vs. Placebo in Acute Unc...
Details : Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Diverticulitis.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
May 07, 2013
Details:
Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diarrhea.
Lead Product(s): Rifamycin,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 24, 2010
Lead Product(s) : Rifamycin,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Details : Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diarrhea.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
September 24, 2010
Details:
Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diarrhea.
Lead Product(s): Rifamycin,Inapplicable
Therapeutic Area: Gastroenterology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Antibiotic
Sponsor: Bausch Health
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 11, 2010
Lead Product(s) : Rifamycin,Inapplicable
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Bausch Health
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Rifamycin is a Antibiotic drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Diarrhea.
Product Name : Undisclosed
Product Type : Antibiotic
Upfront Cash : Inapplicable
June 11, 2010
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EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
CAS Number : 13553-79-2
End Use API : Rifamycin
About The Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs...
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Regulatory Info :
Registration Country : Italy
Brand Name : Rifocin
Dosage Form :
Dosage Strength : 1 Ampoule Im 250 Mg 3 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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Regulatory Info :
Registration Country : Italy
Brand Name : Rifocin
Dosage Form :
Dosage Strength : 1 Ampoule Intralesional Cutaneous/90 Mg 1.8 Ml + 1 Ampoule 16.2 Ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
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ABOUT THIS PAGE
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PharmaCompass offers a list of Rifamycin 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 Rifamycin manufacturer or Rifamycin supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Rifamycin manufacturer or Rifamycin supplier.
PharmaCompass also assists you with knowing the Rifamycin API Price utilized in the formulation of products. Rifamycin API Price is not always fixed or binding as the Rifamycin Price is obtained through a variety of data sources. The Rifamycin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Rifamycin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rifamycin, including repackagers and relabelers. The FDA regulates Rifamycin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rifamycin 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 Rifamycin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rifamycin supplier is an individual or a company that provides Rifamycin active pharmaceutical ingredient (API) or Rifamycin finished formulations upon request. The Rifamycin suppliers may include Rifamycin API manufacturers, exporters, distributors and traders.
click here to find a list of Rifamycin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Rifamycin DMF (Drug Master File) is a document detailing the whole manufacturing process of Rifamycin active pharmaceutical ingredient (API) in detail. Different forms of Rifamycin DMFs exist exist since differing nations have different regulations, such as Rifamycin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Rifamycin DMF submitted to regulatory agencies in the US is known as a USDMF. Rifamycin USDMF includes data on Rifamycin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Rifamycin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Rifamycin suppliers with USDMF 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 Rifamycin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Rifamycin 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 Rifamycin 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 Rifamycin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Rifamycin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Rifamycin suppliers with NDC on PharmaCompass.
Rifamycin 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 Rifamycin 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 Rifamycin GMP manufacturer or Rifamycin GMP API supplier for your needs.
A Rifamycin CoA (Certificate of Analysis) is a formal document that attests to Rifamycin's compliance with Rifamycin specifications and serves as a tool for batch-level quality control.
Rifamycin CoA mostly includes findings from lab analyses of a specific batch. For each Rifamycin 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.
Rifamycin may be tested according to a variety of international standards, such as European Pharmacopoeia (Rifamycin EP), Rifamycin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Rifamycin USP).
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