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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

    API Reference Price

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MARG,,MULUND-WEST"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1684261800,"product":"FOC BEDAQUILINE FUMARATE PORTON GEEL IH FREE OF COST MATERIAL SUPPLIED BY THE CUSTOMER","address":"34TH KM TUMKUR ROAD, TEPPADA BEGURNELAMANGALA","city":"BANGALORE RURAL","supplier":"JOHNSON & JOHNSON","supplierCountry":"CHINA","foreign_port":"BRUSSELS","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"483.54","actualQuantity":"483.54","unit":"KGS","unitRateFc":"3590","totalValueFC":"1742570.7","currency":"USD","unitRateINR":"296534","date":"17-May-2023","totalValueINR":"143386050.4","totalValueInUsd":"1742570.7","indian_port":"BANGALORE AIR","hs_no":"29334900","bill_no":"0","productDescription":"API","marketType":"REGULATED MARKET","country":"China","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"","customerAddress":"34TH KM TUMKUR ROAD, TEPPADA BEGURNELAMANGALA"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1691173800,"product":"FOC BEDAQUILINE FUMARATE MICROFINEIHDISHGEEL","address":"34TH KM TUMKUR ROAD,TEPPADA BEGUR NELAMANGALA ,","city":"BENGALURU","supplier":"JOHNSON & JOHNSON","supplierCountry":"INDIA","foreign_port":"NA","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"293.02","actualQuantity":"293.02","unit":"KGS","unitRateFc":"2973.3","totalValueFC":"968487.3","currency":"EUR","unitRateINR":"271052","date":"05-Aug-2023","totalValueINR":"80225915.7","totalValueInUsd":"968487.3","indian_port":"BANGALORE AIR","hs_no":"29334900","bill_no":"0","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"34TH KM TUMKUR ROAD,TEPPADA BEGUR NELAMANGALA ,"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q4","strtotime":1699209000,"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":"162.86","actualQuantity":"162.862","unit":"KGS","unitRateFc":"3590","totalValueFC":"590847.2","currency":"USD","unitRateINR":"302098.5","date":"06-Nov-2023","totalValueINR":"49200365.91","totalValueInUsd":"590847.2","indian_port":"Bangalore Air","hs_no":"29334900","bill_no":"8648031","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","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":"2023","qtr":"Q4","strtotime":1699209000,"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":"312.17","actualQuantity":"312.17","unit":"KGS","unitRateFc":"3590","totalValueFC":"1132521.8","currency":"USD","unitRateINR":"302098.5","date":"06-Nov-2023","totalValueINR":"94306088.74","totalValueInUsd":"1132521.8","indian_port":"Bangalore Air","hs_no":"29334900","bill_no":"8648031","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","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":"2023","qtr":"Q4","strtotime":1701973800,"product":"(FOC) BEDAQUILINE FUMARATE","address":"34TH KM TUMKUR ROAD,TEPPADA BEGUR","city":"BANGALORE,KARNATAKA","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"231.10","actualQuantity":"231.1","unit":"KGS","unitRateFc":"2973.3","totalValueFC":"754047.5","currency":"EUR","unitRateINR":"271611","date":"08-Dec-2023","totalValueINR":"62769291.7","totalValueInUsd":"754047.5","indian_port":"Bangalore Air","hs_no":"29334900","bill_no":"9131123","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":"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":1710873000,"product":"BEDAQUILINE FUMARATE(RE IMPOT VIDE SB NO:9367238 DT:18.04.2023)","address":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL","city":"HYDERABAD, AP","supplier":"BIOBETTA LIMITED","supplierCountry":"INDIA","foreign_port":"HONG KONG","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"17.52","actualQuantity":"17.518","unit":"KGS","unitRateFc":"8500","totalValueFC":"150183.8","currency":"USD","unitRateINR":"711875","date":"20-Mar-2024","totalValueINR":"12470626.25","totalValueInUsd":"150183.8","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"2668171","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HONG KONG","supplierAddress":"(SHANGHAI)CO.,LTD,SUITE 506-507,BUILDING 35,HH PARK,NO.2777 EAST JINXIU ROAD,PUDONG NEW AREA,SHANGHAI-201 China","customerAddress":"PLOT NO.C-24, MSN HOUSE, INDUSTRIAL"},{"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":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":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"2973.3","totalValueFC":"327004.9","currency":"EUR","unitRateINR":"274286.9","date":"07-Aug-2024","totalValueINR":"27428692.69","totalValueInUsd":"327004.9","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":"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"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1740162600,"product":"[FOC]BEDAQUILINE FUMARATE [FOC] BEDAQUILINE FUMARATE","address":"34TH KM TUMKUR ROAD,TEPPADA BEGUR","city":"BANGALORE,KARNATAKA","supplier":"JOHNSON & JOHNSON","supplierCountry":"BELGIUM","foreign_port":"BRUSSELS","customer":"RECIPHARM AB","customerCountry":"INDIA","quantity":"5.24","actualQuantity":"5.244","unit":"KGS","unitRateFc":"3127.5","totalValueFC":"16548.7","currency":"EUR","unitRateINR":"274435.7","date":"22-Feb-2025","totalValueINR":"1439140.68","totalValueInUsd":"16548.7","indian_port":"Bangalore Air","hs_no":"29334900","bill_no":"8518909","productDescription":"API","marketType":"REGULATED MARKET","country":"BELGIUM","selfForZScoreResived":"Pharma Grade","supplierPort":"BRUSSELS","supplierAddress":"TURNHOUTSEWEG-30 B-2340 BEERSE BEER SE, , Belgium SDNF Belgium","customerAddress":"34TH KM TUMKUR ROAD,TEPPADA BEGUR"}]
    04-Feb-2021
    22-Feb-2025
    KGS
    overview
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    Average Price (USD/KGS)

    Number of Transactions

    Total Quantity (KGS)

    Total Value (USD)

    Quantity (KGS) & Unit rate (USD/KGS) over time

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    API Imports and Exports

    Importing Country Total Quantity
    (KGS)    		 Average Price
    (USD/KGS)    		 Number of Transactions

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    FDF Dossiers

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    01

    Janssen-Cilag

    Italy
    BePharma
    Not Confirmed
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    Janssen-Cilag

    Italy
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    BePharma
    Not Confirmed
    • fda
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    Flag Italy
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Sweden

    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

    Janssen-Cilag

    Italy
    BePharma
    Not Confirmed
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    Janssen-Cilag

    Italy
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    BePharma
    Not Confirmed
    • fda
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    Flag Italy
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Italy

    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

    Janssen-Cilag

    Italy
    BePharma
    Not Confirmed
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    Janssen-Cilag

    Italy
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    BePharma
    Not Confirmed
    • fda
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    Regulatory Info :

    Registration Country : Norway

    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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    04

    Johnson & Johnson Innovative Medici...

    U.S.A
    BePharma
    Not Confirmed
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    Johnson & Johnson Innovative Medici...

    U.S.A
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    BePharma
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    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info : RX

    Registration Country : USA

    BEDAQUILINE FUMARATE

    Brand Name : SIRTURO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 100MG BASE

    Packaging :

    Approval Date : 2012-12-28

    Application Number : 204384

    Regulatory Info : RX

    Registration Country : USA

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    05

    Johnson & Johnson Innovative Medici...

    U.S.A
    BePharma
    Not Confirmed
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    Johnson & Johnson Innovative Medici...

    U.S.A
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    BePharma
    Not Confirmed
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    Regulatory Info : RX

    Registration Country : USA

    BEDAQUILINE FUMARATE

    Brand Name : SIRTURO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 20MG BASE

    Packaging :

    Approval Date : 2020-05-27

    Application Number : 204384

    Regulatory Info : RX

    Registration Country : USA

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    06

    Johnson & Johnson Innovative Medici...

    U.S.A
    BePharma
    Not Confirmed
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    Johnson & Johnson Innovative Medici...

    U.S.A
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    BePharma
    Not Confirmed
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    Flag U.S.A
    Virtual Booth Virtual Booth
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    Regulatory Info : Originator

    Registration Country : South Africa

    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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    FDA Orange Book

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    01

    JANSSEN THERAP

    U.S.A
    BePharma
    Not Confirmed
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    JANSSEN THERAP

    U.S.A
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    BePharma
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    RLD : Yes

    TE Code :

    BEDAQUILINE FUMARATE

    Brand Name : SIRTURO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 100MG BASE

    Approval Date : 2012-12-28

    Application Number : 204384

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

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    02

    JANSSEN THERAP

    U.S.A
    BePharma
    Not Confirmed
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    JANSSEN THERAP

    U.S.A
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    BePharma
    Not Confirmed
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    Flag U.S.A
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    RLD : Yes

    TE Code :

    BEDAQUILINE FUMARATE

    Brand Name : SIRTURO

    Dosage Form : TABLET;ORAL

    Dosage Strength : EQ 20MG BASE

    Approval Date : 2020-05-27

    Application Number : 204384

    RX/OTC/DISCN : RX

    RLD : Yes

    TE Code :

    blank

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    Europe

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    01

    Janssen-Cilag International NV

    Italy
    BePharma
    Not Confirmed
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    Janssen-Cilag International NV

    Italy
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    BePharma
    Not Confirmed
    • fda
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    Flag Italy
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Regulatory Info :

    Registration Country : Sweden

    bedakilinfumarat

    Brand Name : SIRTURO

    Dosage Form : TABLET

    Dosage Strength : 100 MG

    Packaging :

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

    blank

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    02

    JANSSEN CILAG INTERNAT.N.V.

    Italy
    BePharma
    Not Confirmed
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    JANSSEN CILAG INTERNAT.N.V.

    Italy
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    BePharma
    Not Confirmed
    • fda
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    Flag Italy
    Virtual Booth Virtual Booth
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    Regulatory Info :

    Registration Country : Italy

    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

    Janssen-Cilag International N.V.

    Italy
    BePharma
    Not Confirmed
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    Janssen-Cilag International N.V.

    Italy
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    BePharma
    Not Confirmed
    • fda
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    Flag Italy
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    Regulatory Info :

    Registration Country : Norway

    Bedaquiline

    Brand Name : Sirturo

    Dosage Form : Antic-calc Tablet

    Dosage Strength : 100 mg

    Packaging : Bottle

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Norway

    blank

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    Virtual Booth

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    Website

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    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    South Africa

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    01

    Janssen Pharmaceutica (Pty) Ltd

    U.S.A
    BePharma
    Not Confirmed
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    Janssen Pharmaceutica (Pty) Ltd

    U.S.A
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    BePharma
    Not Confirmed
    • fda
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    Regulatory Info : Originator

    Registration Country : South Africa

    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

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    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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