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ACTIVE PHARMA INGREDIENTS

14 API Suppliers, 2 USDMF, 1 EU WC, 1 NDC API, 13 Listed Suppliers, $ API Reference Price

14 API Suppliers
2 USDMF
1 EU WC
1 NDC API
13 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

9 Drugs in Development

INTERMEDIATES

8 Intermediates Suppliers

8 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

6 FDF Dossiers, 2 FDA Orange Book, 3 Europe, 1 South Africa

6 FDF Dossiers
2 FDA Orange Book
3 Europe
1 South Africa

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 1 DKSH, 4 Faran Shimi Pharmaceutical, 11 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 5 DFE Pharma, 4 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 18 Kerry, 9 Microlex e.U, 1 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 14 Roquette, 3 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

52 Fillers, Diluents & Binders, 24 Direct Compression, 18 Disintegrants & Superdisintegrants, 13 Thickeners and Stabilizers, 13 Co-Processed Excipients, 11 Lubricants & Glidants, 11 Granulation, 5 Taste Masking, 5 Controlled & Modified Release, 5 Chewable & Orodispersible Aids, 4 Solubilizers, 4 Emulsifying Agents, 3 Coating Systems & Additives, 3 Parenteral, 2 Surfactant & Foaming Agents, 2 Topical, 2 Rheology Modifiers, 1 Film Formers & Plasticizers, 1 API Stability Enhancers

DIGITAL CONTENT

38 NEWS #PharmaBuzz

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38 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 2 Finished Drug Prices

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1 US Medicaid Prescriptions
2 Finished Drug Prices

MARKET PLACE

7 APIs, 4 FDF Dossiers

marketPlace
7 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 5 US Exclusivities

patents
4 US Patents
5 US Exclusivities

REF. STANDARDS & IMPURITIES

1 Others

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1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

API Suppliers

USDMF

CEP/COS

JDMF

EU WC

KDMF

NDC API

VMF

Listed Suppliers

API REF. PRICE (USD/KG)

$ 7,943

MARKET PLACE

API

FDF

8INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

FDF Dossiers

FDA Orange Book

Europe

Canada

Australia

South Africa

Listed Dossiers

9DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

EDQM

USP

Others

PATENTS & EXCLUSIVITIES

US Patents

US Exclusivities

Health Canada Patents

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Data Compilation #PharmaFlow

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GLOBAL SALES INFORMATION

US Medicaid (USD)

2,147,056

Annual Reports (USD Million)

Finished Drug Prices

111 RELATED EXCIPIENT COMPANIES

179EXCIPIENTS BY APPLICATIONS

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

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 Formula	C₃₆H₃₅BrN₂O₆
Molecular Weight	671.6 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	10
Exact Mass	670.16785 g/mol
Monoisotopic Mass	670.16785 g/mol
Topological Polar Surface Area	120 Å²
Heavy Atom Count	45
Formal Charge	0
Complexity	834
Isotope Atom Count	0
Defined Atom Stereocenter Count	2
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	1
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

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 SUPPLIERS

01

Nuray Chemicals Private Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

Contact Supplier

India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

02

Omgene Life Sciences Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Contact Supplier

India

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT

03

Viatris

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

04

MSN Laboratories

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

Antibody Engineering

Not Confirmed

Not Confirmed

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API Reference Price

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