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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
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
Molecular Weight | 671.6 g/mol |
---|---|
Molecular Formula | C36H35BrN2O6 |
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 Ų |
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 |
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.
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.)
J04AK05
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33268
Submission : 2018-10-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35426
Submission : 2020-12-14
Status : Active
Type : II
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...
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 Imports and Exports
Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
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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
Lead Product(s) : OPC-167832,Bedaquiline,Delamanid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Otsuka Reports Interim Phase 2b/c Data Indicating New Compound May Shorten Tuberculosis
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
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
Lead Product(s) : Bedaquiline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
J&J’s Sirturo for Tuberculosis Receives Full US, EU Approvals
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
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
Lead Product(s) : Delamanid,Bedaquiline,OPC-167832
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Bill & Melinda Gates Foundation
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : Bedaquiline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
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
Lead Product(s) : OPC-167832,Bedaquiline,Delamanid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : GSK
Deal Size : Undisclosed
Deal Type : Collaboration
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
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
Lead Product(s) : OPC-167832,Bedaquiline,Delamanid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Bill & Melinda Gates Foundation
Deal Size : $17.8 million
Deal Type : Funding
Otsuka Awarded Grant for Phase 2 Trial Combining Novel Anti-TB Combo
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
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
Lead Product(s) : Pretomanid,Bedaquiline,Linezolid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Lupin Ltd
Deal Size : Undisclosed
Deal Type : Partnership
TB Alliance and Lupin Announce Commercial Partnership for New Therapy for Highly Drug-Resistant TB
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
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
Lead Product(s) : Bedaquiline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
U.S. FDA Approves New Pediatric Formulation of SIRTURO® (bedaquiline) as Part of Combination Ther...
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
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
Lead Product(s) : Pretomanid,Bedaquiline,Linezolid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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
1 Acetyl Naphthalene (1 Acetonaphthone)
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 ...
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...
3-Benzyl-6-bromo-2-methoxyquinoline
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-...
(R)-(-)-1,1'-Binaphthyl-2,2'-diyl hydrogenphosphat...
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-...
3-Dimethylamino-1-(naphthalen-1-yl)propan-1-one hy...
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-...
3-Benzyl-6-Bromo-2-Methoxy Quinoline
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...
3-(Dimlamino)-1-(Naphthalen-1-yl) Propan-1-one Hcl...
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...
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...
1 Acetyl Naphthalene (1 Acetonaphthone)
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 ...
3-Benzyl-6-bromo-2-methoxyquinoline
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...
Regulatory Info :
Registration Country : Sweden
Brand Name : SIRTURO
Dosage Form : TABLET
Dosage Strength : 100 MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Italy
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
Regulatory Info :
Registration Country : Norway
Brand Name : Sirturo
Dosage Form : Antic-calc Tablet
Dosage Strength : 100 mg
Packaging : Bottle
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Originator
Registration Country : South Africa
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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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.
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.
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.
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.
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.
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).
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.
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.
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) 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.
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).