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Chemistry

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Also known as: Tiacumicin b, Dificid, Dificlir, Lipiarmycin, Opt-80, 873857-62-6
Molecular Formula
C52H74Cl2O18
Molecular Weight
1058.0  g/mol
InChI Key
ZVGNESXIJDCBKN-UUEYKCAUSA-N
FDA UNII
Z5N076G8YQ

Fidaxomicin
A narrow-spectrum macrolide antibacterial agent that is used in the treatment of diarrhea associated with CLOSTRIDIUM DIFFICILE INFECTION.
Fidaxomicin is a Macrolide Antibacterial.
1 2D Structure

Fidaxomicin

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[(2R,3S,4S,5S,6R)-6-[[(3E,5E,8S,9E,11S,12R,13E,15E,18S)-12-[(2R,3S,4R,5S)-3,4-dihydroxy-6,6-dimethyl-5-(2-methylpropanoyloxy)oxan-2-yl]oxy-11-ethyl-8-hydroxy-18-[(1R)-1-hydroxyethyl]-9,13,15-trimethyl-2-oxo-1-oxacyclooctadeca-3,5,9,13,15-pentaen-3-yl]methoxy]-4-hydroxy-5-methoxy-2-methyloxan-3-yl] 3,5-dichloro-2-ethyl-4,6-dihydroxybenzoate
2.1.2 InChI
InChI=1S/C52H74Cl2O18/c1-13-30-22-26(6)33(56)18-16-15-17-31(23-66-51-45(65-12)42(61)44(29(9)67-51)69-49(64)35-32(14-2)36(53)39(58)37(54)38(35)57)48(63)68-34(28(8)55)20-19-25(5)21-27(7)43(30)70-50-41(60)40(59)46(52(10,11)72-50)71-47(62)24(3)4/h15-17,19,21-22,24,28-30,33-34,40-46,50-51,55-61H,13-14,18,20,23H2,1-12H3/b16-15+,25-19+,26-22+,27-21+,31-17+/t28-,29-,30+,33+,34+,40-,41+,42+,43+,44-,45+,46+,50-,51-/m1/s1
2.1.3 InChI Key
ZVGNESXIJDCBKN-UUEYKCAUSA-N
2.1.4 Canonical SMILES
CCC1C=C(C(CC=CC=C(C(=O)OC(CC=C(C=C(C1OC2C(C(C(C(O2)(C)C)OC(=O)C(C)C)O)O)C)C)C(C)O)COC3C(C(C(C(O3)C)OC(=O)C4=C(C(=C(C(=C4O)Cl)O)Cl)CC)O)OC)O)C
2.1.5 Isomeric SMILES
CC[C@H]1/C=C(/[C@H](C/C=C/C=C(/C(=O)O[C@@H](C/C=C(/C=C(/[C@@H]1O[C@H]2[C@H]([C@H]([C@@H](C(O2)(C)C)OC(=O)C(C)C)O)O)\C)\C)[C@@H](C)O)\CO[C@H]3[C@H]([C@H]([C@@H]([C@H](O3)C)OC(=O)C4=C(C(=C(C(=C4O)Cl)O)Cl)CC)O)OC)O)\C
2.2 Other Identifiers
2.2.1 UNII
Z5N076G8YQ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Dificid

2. Lipiarmycin

3. Lipiarmycin A3

4. Lipiarmycin A4

5. Lipiarmycin B

6. Lipiarmycin B3

7. Lipiarmycin B4

8. Par 101

9. Par-101

10. Par101

11. Tiacumicin B

12. Tiacumicin C

2.3.2 Depositor-Supplied Synonyms

1. Tiacumicin B

2. Dificid

3. Dificlir

4. Lipiarmycin

5. Opt-80

6. 873857-62-6

7. Par-101

8. Clostomicin B1

9. Lipiarmicin

10. Difimicin

11. Z5n076g8yq

12. Lipiarmycin A3

13. R-tiacumicin B

14. Lipiarmycin A 3

15. Fidaxomicin [usan]

16. Fidaxomicin [usan:inn]

17. Unii-z5n076g8yq

18. Lipiarrmycin

19. Par 01

20. Clostomycin B1

21. Fidaxomicin (dificid)

22. Brn 5228707

23. Fidaxomicin [mi]

24. Fidaxomicin [inn]

25. Fidaxomicin [jan]

26. Fidaxomicin [vandf]

27. Fidaxomicin [who-dd]

28. Chembl1255800

29. Schembl10000818

30. Fidaxomicin, >=98% (hplc)

31. Gtpl10909

32. Fidaxomicin [orange Book]

33. Dtxsid901016415

34. Fi8

35. Mfcd27976367

36. Db08874

37. F1216

38. Opt-80;par-101;clostomicin B1;tiacumicin B

39. Q5446672

40. (2r,3s,4s,5s,6r)-6-{[(3e,5e,8s,9e,11s,12r,13e,15e,18s)-12-{[(2r,3s,4r,5s)-3,4-dihydroxy-6,6-dimethyl-5-[(2-methylpropanoyl)oxy]oxan-2-yl]oxy}-11-ethyl-8-hydroxy-18-[(1r)-1-hydroxyethyl]-9,13,15-trimethyl-2-oxo-1-oxacyclooctadeca-3,5,9,13,15-pentaen-3-yl]methoxy}-4-hydroxy-5-methoxy-2-methyloxan-3-yl 3,5-dichloro-2-ethyl-4,6-dihydroxybenzoate

41. [(2r,3s,4s,5s,6r)-6-[[(3e,5e,8s,9e,11s,12r,13e,15e,18s)-12-[(2r,3s,4r,5s)-3,4-dihydroxy-6,6-dimethyl-5-(2-methylpropanoyloxy)oxan-2-yl]oxy-11-ethyl-8-hydroxy-18-[(1r)-1-hydroxyethyl]-9,13,15-trimethyl-2-oxo-1-oxacyclooctadeca-3,5,9,13,15-pentaen-3-yl]methoxy]-4-hydroxy-5-methoxy-2-methyloxan-3-yl] 3,5-dichloro-2-ethyl-4,6-dihydroxybenzoate

2.4 Create Date
2006-10-25
3 Chemical and Physical Properties
Molecular Weight 1058.0 g/mol
Molecular Formula C52H74Cl2O18
XLogP36.4
Hydrogen Bond Donor Count7
Hydrogen Bond Acceptor Count18
Rotatable Bond Count15
Exact Mass1056.4252209 g/mol
Monoisotopic Mass1056.4252209 g/mol
Topological Polar Surface Area267 Ų
Heavy Atom Count72
Formal Charge0
Complexity1970
Isotope Atom Count0
Defined Atom Stereocenter Count14
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count5
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameDificid
PubMed HealthFidaxomicin (By mouth)
Drug ClassesAntibiotic
Drug LabelDIFICID (fidaxomicin) is a macrolide antibacterial drug for oral administration. Its CAS chemical name is Oxacyclooctadeca-3,5,9,13,15-pentaen-2-one, 3-[[[6-deoxy-4-O-(3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)-2-O-methyl--D-mannopyranosyl]oxy]meth...
Active IngredientFidaxomicin
Dosage FormTablet
RouteOral
Strength200mg
Market StatusPrescription
CompanyCubist Pharms

2 of 2  
Drug NameDificid
PubMed HealthFidaxomicin (By mouth)
Drug ClassesAntibiotic
Drug LabelDIFICID (fidaxomicin) is a macrolide antibacterial drug for oral administration. Its CAS chemical name is Oxacyclooctadeca-3,5,9,13,15-pentaen-2-one, 3-[[[6-deoxy-4-O-(3,5-dichloro-2-ethyl-4,6-dihydroxybenzoyl)-2-O-methyl--D-mannopyranosyl]oxy]meth...
Active IngredientFidaxomicin
Dosage FormTablet
RouteOral
Strength200mg
Market StatusPrescription
CompanyCubist Pharms

4.2 Drug Indication

Fidaxomicin is indicated for the treatment of _Clostridioides_ (formerly _Clostridium_) _difficile_-associated diarrhea in adult and pediatric patients 6 months of age and older. Fidaxomicin should only be used in patients with proven or strongly suspected _C. difficile_ infection to reduce the risk of development of drug-resistant bacteria and maximize the therapeutic effectiveness of fidaxomicin and other antimicrobial agents.


FDA Label


Dificlir film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12. 5 kg.

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.

Dificlir granules for oral suspension is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age.

Consideration should be given to official guidelines on the appropriate use of antibacterial agents.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Fidaxomicin has a narrow-spectrum antibacterial profile, with potent bactericidal activity specifically against C. difficile. The minimum inhibitory concentration for 90% of organisms for fidaxomicin against _C. difficile_ ranged from 0.0078 to 2 g/mL _in vitro_. The bactericidal activity of fidaxomicin is time-dependent. Other than _C. difficile_, fidaxomicin has moderate inhibitory activity against Gram-positive bacteria (_S. aureus_ and _Enterococcus spp._) and poor activity against normal colonic flora, including anaerobes and enteric Gram-negative bacilli. Isolates of _C. difficile_ that are resistant to rifamycins or other antimicrobial classes (such as cephalosporins, fluoroquinolones, clindamycin) were not shown to be cross-resistant to fidaxomicin.


5.2 MeSH Pharmacological Classification

Anti-Bacterial Agents

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


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
FIDAXOMICIN
5.3.2 FDA UNII
Z5N076G8YQ
5.3.3 Pharmacological Classes
Macrolides [CS]; Macrolide Antibacterial [EPC]
5.4 ATC Code

A07AA12


A - Alimentary tract and metabolism

A07 - Antidiarrheals, intestinal antiinflammatory/antiinfective agents

A07A - Intestinal antiinfectives

A07AA - Antibiotics

A07AA12 - Fidaxomicin


5.5 Absorption, Distribution and Excretion

Absorption

Following oral administration of a single dose of 200 mg fidaxomicin in healthy adults, the Cmax of fidaxomicin and its main metabolite OP-1118 were 5.20 2.81 ng/mL and 12.0 6.06, respectively. The median Tmax of fidaxomicin was 2 hours. The systemic absorption of fidaxomicin following oral administration is minimal. In a food-effect study involving healthy adults in either with a high-fat meal versus under fasting conditions, the Cmax of fidaxomicin and OP-1118 were decreased by 21.5% and 33.4%, respectively; however, this effect is deemed to be clinically insignificant as the therapeutic action of fidaxomicin does not depend on drug concentrations in the systemic circulation.


Route of Elimination

Following oral administration, fidaxomicin is mainly excreted in feces. More than 92% of the dose was recovered in the faces as either the unchanged parent drug or metabolites in one study consisting of healthy adults receiving single doses of 200 mg and 300 mg of fidaxomicin. In another study of healthy adults, approximately 0.59% fo the oral dose (200 mg) administered was recovered in the urine as the main metabolite, OP-1118.


Volume of Distribution

Fidaxomicin is mainly confined to the gastrointestinal tract when orally administered. There is limited information on the volume of distribution of fidaxomicin.


Clearance

There is limited information on the clearance of fidaxomicin.


5.6 Metabolism/Metabolites

Following oral administration, fidaxomicin is transformed to its main and pharmacologically active metabolite, OP-1118, via hydrolysis at the isobutyryl ester. As cytochrome enzymes are not involved in the metabolism of fidaxomicin, it is speculated that this biotransformation is mediated by gastric acid or enzymatic activity of intestinal microsomes.


5.7 Biological Half-Life

Following oral administration of a single dose of 200 mg fidaxomicin in healthy adults, the elimination half-life of fidaxomicin was approximately 11.7 4.80 hours.


5.8 Mechanism of Action

_Clostridium difficile_ is a Gram-positive bacterium that causes various gastrointestinal complications, such as antibiotic-associated diarrhea. _C. difficile_ infection can be caused by antibiotic therapy, resulting in the disruption of the human gut flora leads to an overgrowth of _C. difficile_. The consequences of _C. difficile_ infection can be mild to severe and sometimes fatal. Fidaxomicin gets hydrolyzed to its active metabolite, OP-1118, upon oral administration. Both compounds mediate a bactericidal activity against _C. difficile_ by inhibiting bacterial RNA polymerase at the initiation phase of the transcription cycle. The RNA polymerase is an essential bacterial enzyme that regulates gene expression, catalyzes nucleic acid interactions, and promotes several bacterial enzymatic reactions critical for bacterial survival. The core RNA polymerase is composed of a complex of different subunits and contains the active site. To initiate bacterial transcription, the active site of the core RNA polymerase binds to a promoter-specificity initiation factor, which locates and binds to a promoter region of the DNA. The DNA-RNA polymerase interaction promotes subsequent steps of transcription, which involves the separation of DNA strands. Fidaxomicin binds to the DNA template-RNA polymerase complex, thereby preventing the initial separation of DNA strands during transcription and inhibiting messenger RNA synthesis. The narrow spectrum of antimicrobial activity of fidaxomicin may be explained by the unique target site of fidaxomicin and differing subunits of the core structure of RNA polymerase among bacterial species.


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Fidaxomicin

About the Company : Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-s...

Concord Biotech Limited is a leading vertically integrated, R&D driven biotechnological powerhouse that manufactures Active Pharmaceutical Ingredients through fermentation & semi-synthetic process and Finished formulations. Concord founded in the year 2000 has transformed from a single-product company to a broad-spectrum solution provider, offering products across diversified therapeutic segments. Concord is globally known for its products and has a commanding presence in more than 50 countries worldwide with efficient distribution infrastructure in markets like North America, Europe, Japan, Central & Latin America, Africa, Australia, etc.
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ICHH-25
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Lipiarmycin

About the Company : Livzon Group Fuzhou Fuxing Pharmaceutical Co.,Ltd(FFPC),a subsidiary of Livzon Pharmaceutical Group Inc.,was founded in 1989 as a state-owned company.Now Livzon Fuxing has become a...

Livzon Group Fuzhou Fuxing Pharmaceutical Co.,Ltd(FFPC),a subsidiary of Livzon Pharmaceutical Group Inc.,was founded in 1989 as a state-owned company.Now Livzon Fuxing has become a big pharmaceutial company,which is focusing on producing API/Intermediate of Antibiotics and food additive. We has two subsidiary plants:Fuqing Jiangyin New Plant and Gutian Fuxing Pharmaceutical Co.,Ltd. Jiangyin Plant is located in Fuqing Jiang Industrial Park, near to Jiangyin port with very convenient transportation. Gutian Plant is located in Huangtian town Gutian county. Our company has advanced production technology and modern production facilities which have been approved with cGMP. In April of 2010,We got EU-GMP for Colistine Sulphate.
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ICHH-25
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Lipiarmycin

About the Company : Sajjala Bio Labs is a two year old bio pharmaceutical API production company headquartered in Hyderabad. At the moment, we commercially produce and sell Enoxaparin Sodium and L-asp...

Sajjala Bio Labs is a two year old bio pharmaceutical API production company headquartered in Hyderabad. At the moment, we commercially produce and sell Enoxaparin Sodium and L-asparaginase in the Indian market. Our pipeline of products to be launched in the calendar year 2018 include Liraglutide, Pegylated L-asparaginase, Teriparatide and Hyaluronic Acid. In addition to the production of APIs we also offer a range of R&D services including end-to-end technology transfers and contract product development services. Our infrastructure includes a WHO GMP certifies production facility with 2000 litres fermentation capacity, a DSIR recognised R&D lab, in-house Quality Control facilities and a microbiology lab and all the necessary supporting infrastructure.
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FIDAXOMICIN

About the Company : Established in 2002, Tecoland represents selected cGMP manufacturers with proven capabilities in organic synthesis, fermentation production as well as process and method developmen...

Established in 2002, Tecoland represents selected cGMP manufacturers with proven capabilities in organic synthesis, fermentation production as well as process and method development. Tecoland provides high quality APIs to the pharmaceutical industry, with reliable technical and regulatory support such as USDMF, CEP, EDMF that are critical to the speedy approval of our customers’ regulatory filings.
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Lipiarmycin

About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and...

Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a year at 70 manufacturing facilities. We rank among the leading pharmaceutical companies in the world and are active in 60 countries. Approximately 43,000 employees around the world are dedicated to our mission. Building on our strong global footprint, size and scale, Teva is reaffirming its commitment to place people at the center of our strategy, and enable as many as possible to live better, healthier days.
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Drugs in Development

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Details:

DIFICLIR (fidaxomicin) is a macrolide antibacterial medicine indicated as an initial treatment and first recurrence of Clostridioides difficile infection. Fidaxomicin treats CDI with minimal disruption to the microbiota, helping to preserve colonisation resistance.


Lead Product(s): Fidaxomicin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Dificlir

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 07, 2021

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Tillotts Pharma AG

Switzerland
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Tillotts Pharma AG

Switzerland
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Details : DIFICLIR (fidaxomicin) is a macrolide antibacterial medicine indicated as an initial treatment and first recurrence of Clostridioides difficile infection. Fidaxomicin treats CDI with minimal disruption to the microbiota, helping to preserve colonisation ...

Product Name : Dificlir

Product Type : Large molecule

Upfront Cash : Not Applicable

December 07, 2021

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Details:

Dificlir is an anti-toxin which contains the dynamic substance fidaxomicin used for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients.


Lead Product(s): Fidaxomicin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Dificlir

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 20, 2021

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Tillotts Pharma AG

Switzerland
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ICHH-25
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Tillotts Pharma AG

Switzerland
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ICHH-25
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Details : Dificlir is an anti-toxin which contains the dynamic substance fidaxomicin used for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients.

Product Name : Dificlir

Product Type : Large molecule

Upfront Cash : Not Applicable

May 20, 2021

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Details:

Under the agreement, Astellas Europe will transfer its marketing authorizations for Dificlirtm (generic name: fidaxomicin) tablets for Clostridium difficile infections in Europe, Middle East, Africa and selected Commonwealth of Independent States to Tillotts.


Lead Product(s): Fidaxomicin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Dificlir

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Tillotts Pharma AG

Deal Size: $130.3 million Upfront Cash: Undisclosed

Deal Type: Agreement November 27, 2020

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ICHH-25
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ICHH-25
Not Confirmed

Details : Under the agreement, Astellas Europe will transfer its marketing authorizations for Dificlirtm (generic name: fidaxomicin) tablets for Clostridium difficile infections in Europe, Middle East, Africa and selected Commonwealth of Independent States to Till...

Product Name : Dificlir

Product Type : Large molecule

Upfront Cash : Undisclosed

November 27, 2020

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Details:

Dificid (fidaxomicin) is an oral, macrolide antibacterial medicine approved for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.


Lead Product(s): Fidaxomicin

Therapeutic Area: Infections and Infectious Diseases Brand Name: Dificid

Study Phase: ApprovedProduct Type: Large molecule

Sponsor: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable January 27, 2020

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Merck & Co

U.S.A
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ICHH-25
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Merck & Co

U.S.A
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Details : Dificid (fidaxomicin) is an oral, macrolide antibacterial medicine approved for the treatment of Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) in children aged six months and older.

Product Name : Dificid

Product Type : Large molecule

Upfront Cash : Not Applicable

January 27, 2020

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FDF Dossiers

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Actavis Inc

Ireland
ICHH-25
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Actavis Inc

Ireland
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FIDAXOMICIN

Brand Name : FIDAXOMICIN

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 2024-01-16

Application Number : 208443

Regulatory Info : DISCN

Registration Country : USA

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ICHH-25
Not Confirmed
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fidaxomicin

Brand Name : DIFICLIR

Dosage Form : FILM COATED PILL

Dosage Strength : 200 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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ICHH-25
Not Confirmed
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Lipiarmycin

Brand Name : Dificlir

Dosage Form : Fidaxomicina 200Mg 20 Joined' Oral Use

Dosage Strength : 2x10 cpr riv 200 mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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Lipiarmycin

Brand Name : Dificlir

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 200 mg

Packaging : Blister, endose

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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Clinigen Group

United Kingdom
ICHH-25
Not Confirmed
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Clinigen Group

United Kingdom
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ICHH-25
Not Confirmed

Fidaxomicin

Brand Name : Fidicid 200 mg

Dosage Form : TAB

Dosage Strength : 200mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Orginator

Registration Country : South Africa

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CUBIST PHARMS INC

Switzerland
ICHH-25
Not Confirmed
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CUBIST PHARMS INC

Switzerland
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ICHH-25
Not Confirmed

FIDAXOMICIN

Brand Name : DIFICID

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Packaging :

Approval Date : 2011-05-27

Application Number : 201699

Regulatory Info : RX

Registration Country : USA

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CUBIST PHARMS INC

Switzerland
ICHH-25
Not Confirmed
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CUBIST PHARMS INC

Switzerland
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ICHH-25
Not Confirmed

FIDAXOMICIN

Brand Name : DIFICID

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 40MG/ML

Packaging :

Approval Date : 2020-01-24

Application Number : 213138

Regulatory Info : RX

Registration Country : USA

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ICHH-25
Not Confirmed
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FIDAXOMICIN

Brand Name : DIFICID

Dosage Form : TABLET

Dosage Strength : 200MG

Packaging : 20

Approval Date :

Application Number : 2387174

Regulatory Info : Prescription

Registration Country : Canada

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Tillotts Pharma AG

Switzerland
ICHH-25
Not Confirmed
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Tillotts Pharma AG

Switzerland
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ICHH-25
Not Confirmed

Fidaxomicinum

Brand Name : Dificlir

Dosage Form : Film-Coated Tablets

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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FDA Orange Book

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ACTAVIS LABS FL

Ireland
ICHH-25
Not Confirmed
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ACTAVIS LABS FL

Ireland
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ICHH-25
Not Confirmed

FIDAXOMICIN

Brand Name : FIDAXOMICIN

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2024-01-16

Application Number : 208443

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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CUBIST PHARMS LLC

Switzerland
ICHH-25
Not Confirmed
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CUBIST PHARMS LLC

Switzerland
arrow
ICHH-25
Not Confirmed

FIDAXOMICIN

Brand Name : DIFICID

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG

Approval Date : 2011-05-27

Application Number : 201699

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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CUBIST PHARMS LLC

Switzerland
ICHH-25
Not Confirmed
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CUBIST PHARMS LLC

Switzerland
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ICHH-25
Not Confirmed

FIDAXOMICIN

Brand Name : DIFICID

Dosage Form : FOR SUSPENSION;ORAL

Dosage Strength : 40MG/ML

Approval Date : 2020-01-24

Application Number : 213138

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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South Africa

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01

ICHH-25
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Fidaxomicin

Brand Name : Fidicid 200 mg

Dosage Form : TAB

Dosage Strength : 200mg

Packaging : 20X1mg

Approval Date :

Application Number :

Regulatory Info : Orginator

Registration Country : South Africa

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ABOUT THIS PAGE

Looking for 873857-62-6 / Fidaxomicin API manufacturers, exporters & distributors?

Fidaxomicin manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Fidaxomicin 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 Fidaxomicin manufacturer or Fidaxomicin supplier for your needs.

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

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

API | Excipient name

Fidaxomicin

Synonyms

Tiacumicin b, Dificid, Dificlir, Lipiarmycin, Opt-80, 873857-62-6

Cas Number

873857-62-6

Unique Ingredient Identifier (UNII)

Z5N076G8YQ

About Fidaxomicin

A narrow-spectrum macrolide antibacterial agent that is used in the treatment of diarrhea associated with CLOSTRIDIUM DIFFICILE INFECTION.

Fidaxomicin Manufacturers

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

Fidaxomicin Suppliers

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

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

Fidaxomicin USDMF

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

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

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

Fidaxomicin WC

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

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

Fidaxomicin NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Fidaxomicin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Fidaxomicin API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Fidaxomicin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Fidaxomicin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Fidaxomicin NDC to their finished compounded human drug products, they may choose to do so.

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

Fidaxomicin GMP

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

Fidaxomicin CoA

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

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

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

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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