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ACTIVE PHARMA INGREDIENTS

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

15 API Suppliers
2 USDMF
1 EU WC
1 NDC API
14 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

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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

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7 APIs
4 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents, 5 US Exclusivities

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4 US Patents
5 US Exclusivities

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1 Others

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1 Others

Synopsis

ACTIVE PHARMA INGREDIENTS

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API REF. PRICE (USD/KG)

$ 5,896

MARKET PLACE

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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

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US Patents

US Exclusivities

Health Canada Patents

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GLOBAL SALES INFORMATION

US Medicaid (USD)

2,147,056

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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

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API Reference Price

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Number of Transactions

Total Quantity (KGS)

Total Value (USD)

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

API Imports and Exports

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

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Drugs in Development

01 Johnson & Johnson Innovative Medicine

U.S.A

PharmaVenue

Not Confirmed

02 Otsuka Pharmaceutical

Japan

PharmaVenue

Not Confirmed

03 Johnson & Johnson Innovative Medicine

U.S.A

PharmaVenue

Not Confirmed

04 Otsuka Pharmaceutical

Japan

PharmaVenue

Not Confirmed

05 Bill & Melinda Gates Foundation

U.S.A

PharmaVenue

Not Confirmed

06 TB Alliance

U.S.A

PharmaVenue

Not Confirmed

07 Otsuka Pharmaceutical

Japan

PharmaVenue

Not Confirmed

08 TB Alliance

U.S.A

PharmaVenue

Not Confirmed

09 Johnson & Johnson Innovative Medicine

U.S.A

PharmaVenue

Not Confirmed

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INTERMEDIATES SUPPLIERS

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FDF Dossiers

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FDA Orange Book

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Europe

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South Africa

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ABOUT THIS PAGE

Bedaquiline Manufacturers

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

Bedaquiline Suppliers

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

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

Bedaquiline USDMF

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

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

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

Bedaquiline WC

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

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

Bedaquiline 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Bedaquiline GMP

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

Bedaquiline CoA

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

Bedaquiline CoA mostly includes findings from lab analyses of a specific batch. For each Bedaquiline 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Bedaquiline EP), Bedaquiline JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Bedaquiline 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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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

15 API Suppliers

2 USDMF

1 EU WC

1 NDC API

14 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

9 Drugs in Development

INTERMEDIATES

8 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

6 FDF Dossiers

2 FDA Orange Book

3 Europe

1 South Africa

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EXCIPIENTS BY APPLICATIONS

52 Fillers, Diluents & Binders

24 Direct Compression

18 Disintegrants & Superdisintegrants

13 Thickeners and Stabilizers

13 Co-Processed Excipients

11 Granulation

11 Lubricants & Glidants

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

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

2 Finished Drug Prices

MARKET PLACE

7 APIs

4 FDF Dossiers

PATENTS & EXCLUSIVITIES

4 US Patents

5 US Exclusivities

REF. STANDARDS & IMPURITIES

1 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 5,896

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