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Chemistry

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Also known as: 845533-86-0, Bedaquiline (fumarate), Sirturo, R403323, Bedaquiline fumarate [usan], P04qx2c1a5
Molecular Formula
C36H35BrN2O6
Molecular Weight
671.6  g/mol
InChI Key
ZLVSPMRFRHMMOY-WWCCMVHESA-N
FDA UNII
P04QX2C1A5

Bedaquiline
1 2D Structure

Bedaquiline

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(1R,2S)-1-(6-bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-naphthalen-1-yl-1-phenylbutan-2-ol;(E)-but-2-enedioic acid
2.1.2 InChI
InChI=1S/C32H31BrN2O2.C4H4O4/c1-35(2)19-18-32(36,28-15-9-13-22-10-7-8-14-26(22)28)30(23-11-5-4-6-12-23)27-21-24-20-25(33)16-17-29(24)34-31(27)37-3;5-3(6)1-2-4(7)8/h4-17,20-21,30,36H,18-19H2,1-3H3;1-2H,(H,5,6)(H,7,8)/b;2-1+/t30-,32-;/m1./s1
2.1.3 InChI Key
ZLVSPMRFRHMMOY-WWCCMVHESA-N
2.1.4 Canonical SMILES
CN(C)CCC(C1=CC=CC2=CC=CC=C21)(C(C3=CC=CC=C3)C4=C(N=C5C=CC(=CC5=C4)Br)OC)O.C(=CC(=O)O)C(=O)O
2.1.5 Isomeric SMILES
CN(C)CC[C@@](C1=CC=CC2=CC=CC=C21)([C@H](C3=CC=CC=C3)C4=C(N=C5C=CC(=CC5=C4)Br)OC)O.C(=C/C(=O)O)\C(=O)O
2.2 Other Identifiers
2.2.1 UNII
P04QX2C1A5
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (1r,2s)-1-(6-bromo-2-methoxy-quinolin-3-yl)-4-dimethylamino-2-(3-fluorophenyl)-1-phenyl-butan-2-ol

2. Aids-222089

3. Aids222088

4. Bedaquiline

5. R207910

6. Tmc207

2.3.2 Depositor-Supplied Synonyms

1. 845533-86-0

2. Bedaquiline (fumarate)

3. Sirturo

4. R403323

5. Bedaquiline Fumarate [usan]

6. P04qx2c1a5

7. Chebi:72295

8. 845533-86-0 (fumarate)

9. R-403323

10. R 403323

11. Unii-p04qx2c1a5

12. (1r,2s)-1-(6-bromo-2-methoxy-3-quinolyl)-4-dimethylamino-2-(1-naphthyl)-1-phenyl-butan-2-ol Fumarate

13. Bedaquilinefumarate

14. Sirturo (tn)

15. Chembl2105700

16. Schembl20496928

17. Bedaquiline Fumarate [mi]

18. Bedaquiline Fumarate; R403323

19. Bedaquiline Fumarate (jan/usan)

20. Bedaquiline Fumarate [jan]

21. Dtxsid401004837

22. Ex-a2647

23. Hy-14881a

24. S4854

25. Bedaquiline Fumarate [who-dd]

26. Ccg-270358

27. Ac-28750

28. As-57710

29. Bedaquiline Fumarate [orange Book]

30. D09873

31. R403323;tmc207 Fumarate;r207910 Fumarate

32. Q27139886

33. (1r,2s)-1-(6-bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-(1-naphthyl)-1-phenylbutan-2-ol Bis[(2z)-but-2-enedioate]

34. (1r,2s)-1-(6-bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-(naphthalen-1-yl)-1- Phenylbutan-2-ol (2e)-but-2-enedioate Salt (1:1)

35. (1r,2s)-1-(6-bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-(naphthalen-1-yl)-1-phenylbutan-2-ol Fumarate

36. (1r,2s)-1-(6-bromo-2-methoxyquinolin-3-yl)-4-(dimethylamino)-2-naphthalen-1-yl-1-phenylbutan-2-ol;(e)-but-2-enedioic Acid

37. 3-quinolineethanol, 6-bromo-.alpha.-(2-(dimethylamino)ethyl)-2-methoxy-.alpha.-1-naphthalenyl-.beta.-phenyl-, (.alpha.s,.beta.r)-, (2e)-2-butenedioate (1:1) (salt)

38. 3-quinolineethanol, 6-bromo-alpha-(2-(dimethylamino)ethyl)-2-methoxy-alpha-1-naphthalenyl- -phenyl-, (s,r)-, (2e)-2-butenedioate (1:1) (salt)

39. 6-bromo-3-[(1r,2s)-4-(dimethylammonio)-2-hydroxy-2-(1-naphthyl)-1-phenylbutyl]-2-methoxyquinolinium (2e)-but-2-enedioate

2.4 Create Date
2008-06-23
3 Chemical and Physical Properties
Molecular Weight 671.6 g/mol
Molecular Formula C36H35BrN2O6
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count8
Rotatable Bond Count10
Exact Mass670.16785 g/mol
Monoisotopic Mass670.16785 g/mol
Topological Polar Surface Area120 Ų
Heavy Atom Count45
Formal Charge0
Complexity834
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Sirturo is indicated for use as part of an appropriate combination regimen for pulmonary multidrug resistant tuberculosis (MDR TB) in adults and adolescent patients (12 years to less than 18 years of age and weighing at least 30 kg) when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability. Consideration should be given to official guidance on the appropriate use of antibacterial agents.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antitubercular Agents

Drugs used in the treatment of tuberculosis. They are divided into two main classes: "first-line" agents, those with the greatest efficacy and acceptable degrees of toxicity used successfully in the great majority of cases; and "second-line" drugs used in drug-resistant cases or those in which some other patient-related condition has compromised the effectiveness of primary therapy. (See all compounds classified as Antitubercular Agents.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Diarylquinolines [CS]; Diarylquinoline Antimycobacterial [EPC]
5.3 ATC Code

J04AK05


USDMF

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PEGS Boston Summit
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PEGS Boston Summit
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35426

Submission : 2020-12-14

Status : Active

Type : II

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EU WC

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BEDAQUILINE FUMARATE IH

Date of Issue : 2020-07-27

Valid Till : 2022-08-08

Written Confirmation Number : WC-0383A6

Address of the Firm : Sy. No.455/A, 455/AA, 455/E & 455/EE Chandampet Village Shankarampet Mandal Meda...

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BEDAQUILINE FUMARATE

NDC Package Code : 69766-058

Start Marketing Date : 2018-10-29

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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API Reference Price

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Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705516200,"product":"(FOC) BEDAQUILINE FUMARATE (PORTON GEL)","address":"34TH KM TUMKUR ROAD,TEPPADA BEGUR","city":"BANGALORE,KARNATAKA","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"268.90","actualQuantity":"268.9","unit":"KGS","unitRateFc":"3590","totalValueFC":"978572.4","currency":"USD","unitRateINR":"302457.5","date":"18-Jan-2024","totalValueINR":"81330821.75","totalValueInUsd":"978572.4","indian_port":"Bangalore Air","hs_no":"29334900","bill_no":"9723525","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG-30 B-2340 BEERSE BEERSE, , BelgiumSDNF Belgium","customerAddress":"34TH KM TUMKUR ROAD,TEPPADA BEGUR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q1","strtotime":1705516200,"product":"(FOC) BEDAQUILINE FUMARATE (PORTON GEL)","address":"34TH KM TUMKUR ROAD,TEPPADA BEGUR","city":"BANGALORE,KARNATAKA","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"687.37","actualQuantity":"687.367","unit":"KGS","unitRateFc":"3590","totalValueFC":"2501444.4","currency":"USD","unitRateINR":"302457.5","date":"18-Jan-2024","totalValueINR":"207899304.4","totalValueInUsd":"2501444.4","indian_port":"Bangalore Air","hs_no":"29334900","bill_no":"9723525","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG-30 B-2340 BEERSE BEERSE, , BelgiumSDNF Belgium","customerAddress":"34TH KM TUMKUR ROAD,TEPPADA BEGUR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1720463400,"product":"(N.C.V.) BEDAQUILINE FUMARATE (30C PLASTIC JAR IN ALU FOILE2\/2)(FOR TESTING PURPOSE ONLY)","address":"30 FORJETT STREET","city":"MUMBAI, MAHARASHTRA.","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"JOHNSON & JOHNSON","customerCountry":"INDIA","quantity":"0.48","actualQuantity":"481.69","unit":"GMS","unitRateFc":"2.3","totalValueFC":"1237.2","currency":"EUR","unitRateINR":"214.7","date":"09-Jul-2024","totalValueINR":"103415.99","totalValueInUsd":"1237.2","indian_port":"Bombay Air","hs_no":"29334900","bill_no":"4404760","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG 30 B-2340 Beerse, , BelgiumSDNF Belgium","customerAddress":"30 FORJETT STREET"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722969000,"product":"[FOC]BEDAQUILINE FUMARATE","address":"34TH KM TUMKUR ROAD,TEPPADA BEGUR","city":"BANGALORE,KARNATAKA","supplier":"JOHNSON & JOHNSON","supplierCountry":"INDIA","foreign_port":"BRUSSELS","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"41.29","actualQuantity":"41.29","unit":"KGS","unitRateFc":"2973.3","totalValueFC":"135020.3","currency":"EUR","unitRateINR":"274286.9","date":"07-Aug-2024","totalValueINR":"11325307.41","totalValueInUsd":"135020.3","indian_port":"Bangalore Air","hs_no":"29334900","bill_no":"4933656","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG-30 B-2340 BEERSE BEERSE, , BelgiumSDNF Belgium","customerAddress":"34TH KM TUMKUR ROAD,TEPPADA BEGUR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"[FOC] BEDAQUILINE FUMARATE [PORTON GEEL]","address":"34TH KM TUMKUR ROAD,TEPPADA BEGUR","city":"BANGALORE,KARNATAKA","supplier":"JOHNSON & JOHNSON","supplierCountry":"CHINA","foreign_port":"BRUSSELS","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"10.00","actualQuantity":"10","unit":"KGS","unitRateFc":"3590","totalValueFC":"36349.3","currency":"USD","unitRateINR":"304611.5","date":"05-Sep-2024","totalValueINR":"3046115","totalValueInUsd":"36349.3","indian_port":"Bangalore Air","hs_no":"29334900","bill_no":"5447630","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG-30 B-2340 BEERSE BEER SE, , Belgium SDNF Belgium Belgium","customerAddress":"34TH KM TUMKUR ROAD,TEPPADA BEGUR"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1725474600,"product":"[FOC] BEDAQUILINE FUMARATE [PORTON GEEL]","address":"34TH KM TUMKUR ROAD,TEPPADA BEGUR","city":"BANGALORE,KARNATAKA","supplier":"JOHNSON & JOHNSON","supplierCountry":"CHINA","foreign_port":"BRUSSELS","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"382.59","actualQuantity":"382.59","unit":"KGS","unitRateFc":"3590","totalValueFC":"1390687.5","currency":"USD","unitRateINR":"304611.5","date":"05-Sep-2024","totalValueINR":"116541313.8","totalValueInUsd":"1390687.5","indian_port":"Bangalore Air","hs_no":"29334900","bill_no":"5447630","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG-30 B-2340 BEERSE BEER SE, , Belgium SDNF Belgium Belgium","customerAddress":"34TH KM TUMKUR ROAD,TEPPADA BEGUR"}]
04-Feb-2021
25-Jan-2025
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Drugs in Development

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Details:

OPC-167832 (quabodepistat) is a potent and orally active dprE1 inhibitor, which is being evaluated in combination with delamanid & bedaquiline for the treatment of pulmonary tuberculosis.


Lead Product(s): OPC-167832,Bedaquiline,Delamanid

Therapeutic Area: Infections and Infectious Diseases Brand Name: OPC-167832

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 22, 2024

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01

BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : OPC-167832 (quabodepistat) is a potent and orally active dprE1 inhibitor, which is being evaluated in combination with delamanid & bedaquiline for the treatment of pulmonary tuberculosis.

Product Name : OPC-167832

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

March 22, 2024

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Details:

Sirturo (bedaquiline) is an approved ATP synthase inhibitor. It is given orally for the treatment in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary MDR-TB.


Lead Product(s): Bedaquiline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Sirturo

Study Phase: Approved FDFProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 07, 2024

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02

BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : Sirturo (bedaquiline) is an approved ATP synthase inhibitor. It is given orally for the treatment in adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary MDR-TB.

Product Name : Sirturo

Product Type : Antibiotic

Upfront Cash : Inapplicable

February 07, 2024

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Details:

This program is evaluating two novel drug regimens comprising five antibacterial agents—bedaquiline, delamanid, pretomanid, quabodepistat (formerly known as OPC-167832), and sutezolid.


Lead Product(s): Delamanid,Bedaquiline,OPC-167832

Therapeutic Area: Infections and Infectious Diseases Brand Name: Deltyba

Study Phase: Phase IIProduct Type: Antibiotic

Sponsor: Bill & Melinda Gates Foundation

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 08, 2023

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BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : This program is evaluating two novel drug regimens comprising five antibacterial agents—bedaquiline, delamanid, pretomanid, quabodepistat (formerly known as OPC-167832), and sutezolid.

Product Name : Deltyba

Product Type : Antibiotic

Upfront Cash : Inapplicable

September 08, 2023

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Details:

Sirturo (bedaquiline) is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary MDR-TB.


Lead Product(s): Bedaquiline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Sirturo

Study Phase: Approved FDFProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 11, 2023

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BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : Sirturo (bedaquiline) is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary MDR-TB.

Product Name : Sirturo

Product Type : Antibiotic

Upfront Cash : Inapplicable

July 11, 2023

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Details:

The PAN-TB collaboration is a first-of-its-kind effort to accelerate development of a drug regimen capable of treating all forms of TB, and identifying promising regimens for further development including OPC-167832.


Lead Product(s): OPC-167832,Bedaquiline,Delamanid

Therapeutic Area: Infections and Infectious Diseases Brand Name: OPC-167832

Study Phase: PreclinicalProduct Type: Other Small Molecule

Sponsor: GSK

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration August 17, 2022

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BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : The PAN-TB collaboration is a first-of-its-kind effort to accelerate development of a drug regimen capable of treating all forms of TB, and identifying promising regimens for further development including OPC-167832.

Product Name : OPC-167832

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

August 17, 2022

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Details:

The grant will enable Otsuka to advance clinical trials of its investigational compound OPC-167832, in combination with its delamanid and Johnson & Johnson’s bedaquiline, for patients with drug-susceptible pulmonary tuberculosis (DS-TB).


Lead Product(s): OPC-167832,Bedaquiline,Delamanid

Therapeutic Area: Infections and Infectious Diseases Brand Name: OPC-167832

Study Phase: Phase I/ Phase IIProduct Type: Other Small Molecule

Sponsor: Bill & Melinda Gates Foundation

Deal Size: $17.8 million Upfront Cash: Undisclosed

Deal Type: Funding October 08, 2021

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BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : The grant will enable Otsuka to advance clinical trials of its investigational compound OPC-167832, in combination with its delamanid and Johnson & Johnson’s bedaquiline, for patients with drug-susceptible pulmonary tuberculosis (DS-TB).

Product Name : OPC-167832

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

October 08, 2021

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Details:

Lupin intends to commercialize the anti-tuberculosis (TB) medicine, Pretomanid, in approximately 140 countries and territories, including many of the highest TB burden countries around the world.


Lead Product(s): Pretomanid,Bedaquiline,Linezolid

Therapeutic Area: Infections and Infectious Diseases Brand Name: PA-824

Study Phase: Approved FDFProduct Type: Antibiotic

Sponsor: Lupin Ltd

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership June 09, 2021

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TB Alliance

U.S.A
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BioProcess International Europe
Not Confirmed

TB Alliance

U.S.A
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BioProcess International Europe
Not Confirmed

Details : Lupin intends to commercialize the anti-tuberculosis (TB) medicine, Pretomanid, in approximately 140 countries and territories, including many of the highest TB burden countries around the world.

Product Name : PA-824

Product Type : Antibiotic

Upfront Cash : Undisclosed

June 09, 2021

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Details:

SIRTURO® is now indicated for use as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multidrug-resistant tuberculosis (MDR‑TB).


Lead Product(s): Bedaquiline

Therapeutic Area: Infections and Infectious Diseases Brand Name: Sirturo

Study Phase: Approved FDFProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 27, 2020

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BioProcess International Europe
Not Confirmed
BioProcess International Europe
Not Confirmed

Details : SIRTURO® is now indicated for use as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multidrug-resistant tuberculosis (MDR‑TB).

Product Name : Sirturo

Product Type : Antibiotic

Upfront Cash : Inapplicable

May 27, 2020

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Details:

The new drug was authorised as part of a three-drug, six month, all-oral regimen for the treatment of adults with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.


Lead Product(s): Pretomanid,Bedaquiline,Linezolid

Therapeutic Area: Infections and Infectious Diseases Brand Name: PA-824

Study Phase: Approved FDFProduct Type: Antibiotic

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 08, 2020

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TB Alliance

U.S.A
arrow
BioProcess International Europe
Not Confirmed

TB Alliance

U.S.A
arrow
BioProcess International Europe
Not Confirmed

Details : The new drug was authorised as part of a three-drug, six month, all-oral regimen for the treatment of adults with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.

Product Name : PA-824

Product Type : Antibiotic

Upfront Cash : Inapplicable

March 08, 2020

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INTERMEDIATE SUPPLIERS

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01

DKSH

Switzerland
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDKSH is your trusted partner for companies looking to grow their business in Asia & beyond.

CAS Number : 941-98-0

End Use API : Bedaquiline

About The Company : DKSH, founded with the goal of improving people's lives, assists businesses with market expansion and business growth in both existing and emerging markets. It ...

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02

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed
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CAS Number : 645-45-4

End Use API : Bedaquiline

About The Company : Bhushilpa Chemicals was set up in 2001 with a vision to develop, manufacture and market specialty chemicals and drug intermediates through implementation of qu...

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03

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed
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CAS Number : 654655-69-3

End Use API : Bedaquiline

About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...

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PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed
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CAS Number : 39648-67-4

End Use API : Bedaquiline

About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...

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PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed
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CAS Number : 5409-58-5

End Use API : Bedaquiline

About The Company : Cangzhou Enke Pharma Tech Co.,ltd. is located in Cangzhou City, Hebei province ,where is a famous petroleum chemical industry city in China. Enke Pharma a high-...

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PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed
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CAS Number : 654655-69-3

End Use API : Bedaquiline

About The Company : Corey Organics is focused in developing and manufacturing of Active Pharmaceutical Ingredients (APIs), registered Pharma Intermediates, Fine Chemicals and Pyrid...

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07

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed
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CAS Number : 5409-58-5

End Use API : Bedaquiline

About The Company : Corey Organics is focused in developing and manufacturing of Active Pharmaceutical Ingredients (APIs), registered Pharma Intermediates, Fine Chemicals and Pyrid...

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08

PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed
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CAS Number : 941-98-0

End Use API : Bedaquiline

About The Company : We are a top producer of Pharmaceutical Intermediates, Specialty Chemicals, and More, with origins dating back to 1998. Globally renowned for its Organic Compou...

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PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed
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CAS Number : 941-98-0

End Use API : Bedaquiline

About The Company : A journey of thousand miles begins with a small step. The story of Sodium Metal Pvt. Ltd. is no different. Established in 1971 the Company began its operations ...

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PEGS Boston Summit
Not Confirmed
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PEGS Boston Summit
Not Confirmed
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CAS Number : CAS-654655-69-3

End Use API : Bedaquiline

About The Company : Venkata Narayana Active Ingredients (Formerly Nutra Specialties Private Limited) Promoted by a well-known business house of India, Mr. Abhaya Kumar Jain who has...

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Europe

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01

China Battery Fair
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China Battery Fair
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bedakilinfumarat

Brand Name : SIRTURO

Dosage Form : TABLET

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

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02

China Battery Fair
Not Confirmed
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China Battery Fair
Not Confirmed

Bedaquiline

Brand Name : Sirturo

Dosage Form : Bedaquilina 100Mg 188 Unita' Oral Use

Dosage Strength : 188 CPR 100 mg bottle

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Italy

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03

China Battery Fair
Not Confirmed
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China Battery Fair
Not Confirmed

Bedaquiline

Brand Name : Sirturo

Dosage Form : Antic-calc Tablet

Dosage Strength : 100 mg

Packaging : Bottle

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

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South Africa

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China Battery Fair
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China Battery Fair
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Bedaquiline

Brand Name : SIRTURO

Dosage Form : CAP

Dosage Strength : 100mg

Packaging : 188X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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ABOUT THIS PAGE

Looking for 845533-86-0 / Bedaquiline API manufacturers, exporters & distributors?

Bedaquiline manufacturers, exporters & distributors 1

29

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

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

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

API | Excipient name

Bedaquiline

Synonyms

845533-86-0, Bedaquiline (fumarate), Sirturo, R403323, Bedaquiline fumarate [usan], P04qx2c1a5

Cas Number

845533-86-0

Unique Ingredient Identifier (UNII)

P04QX2C1A5

Bedaquiline Fumarate Manufacturers

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

Bedaquiline Fumarate Suppliers

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

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

Bedaquiline Fumarate USDMF

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

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

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

Bedaquiline Fumarate WC

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

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

Bedaquiline Fumarate 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 Bedaquiline Fumarate as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Bedaquiline Fumarate GMP

Bedaquiline Fumarate 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 Bedaquiline Fumarate 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 Bedaquiline Fumarate GMP manufacturer or Bedaquiline Fumarate GMP API supplier for your needs.

Bedaquiline Fumarate CoA

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

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

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