Synopsis
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Listed Dossiers
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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
API SUPPLIERS
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35426
Submission : 2020-12-14
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33268
Submission : 2018-10-30
Status : Active
Type : II
Date of Issue : 2020-07-27
Valid Till : 2022-08-08
Written Confirmation Number : WC-0383A6
Address of the Firm :
NDC Package Code : 69766-058
Start Marketing Date : 2018-10-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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USDMF
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
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EU WC
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
NDC Package Code : 69766-058
Start Marketing Date : 2018-10-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
About the Company : Established in 2012, Nuray Chemicals Pvt Ltd is an API manufacturer for highly regulated markets. Its manufacturing facility with state-of-the-art R&D is located near Chennai in th...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
About the Company : Since 2004, Arene Lifesciences Private Limited is committed to a cause to deliver the best and to aim for continuous improvement in order to transform new knowledge into innovative...
About the Company : In the dinamic pharmaceutical field, DEAFARMA is the reference point for primaries Pharmaceutical Laboratories for over twenty years, even in the national and international territo...
About the Company : Epoch-Labs is a Hyderabad, India based Research Organization that gives science administrations to expansive pharmaceutical organization, agrochemical organizations crosswise over ...
About the Company : Haoyuan Chemexpress Co., Ltd., located in Shanghai Zhangjiang Biomedical Base, is a high-tech company specializing in customized chemical synthesis and R&D of pharmaceutical interm...
About the Company : "The company was named after the Lupin flower because of the inherent qualities of the flower and what it personifies and stands for. The Lupin flower is known to nourish the land,...
About the Company : Founded in 2003, Hyderabad-based MSN Labs is one of the fastest-growing research-based pharmaceutical company in India. Boasting a diverse product portfolio, with multiple products...
About the Company : NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 e...
About the Company : Shanvr Life Sciences Pvt Ltd is a pharmaceutical product development company with a strong emphasis on research. Our approach centers around the creation of specialized generic, on...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API Imports and Exports
| Importing Country | Total Quantity (KGS) |
Average Price (USD/KGS) |
Number of Transactions |
|---|
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Drugs in Development
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: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 02, 2024
Lead Product(s) : Bedaquiline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Sirturo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
July 02, 2024
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,Delamanid,Bedaquiline
Therapeutic Area: Infections and Infectious Diseases Brand Name: OPC-167832
Study Phase: Phase IIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 22, 2024
Lead Product(s) : OPC-167832,Delamanid,Bedaquiline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : OPC-167832
Molecule Type : Small molecule
Upfront Cash : Not Applicable
March 22, 2024
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: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 07, 2023
Lead Product(s) : Bedaquiline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Sirturo
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 07, 2023
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: Small molecule
Sponsor: Bill & Melinda Gates Foundation
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 09, 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 : Not Applicable
Deal Type : Not Applicable
Details : This program is evaluating two novel drug regimens comprising five antibacterial agents—bedaquiline, delamanid, pretomanid, quabodepistat (formerly known as OPC-167832), and sutezolid.
Brand Name : Deltyba
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 09, 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,Delamanid,Bedaquiline
Therapeutic Area: Infections and Infectious Diseases Brand Name: OPC-167832
Study Phase: PreclinicalProduct Type: Small molecule
Sponsor: Johnson & Johnson Innovative Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration August 17, 2022
Lead Product(s) : OPC-167832,Delamanid,Bedaquiline
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Preclinical
Partner/Sponsor/Collaborator : Johnson & Johnson Innovative Medicine
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.
Brand Name : OPC-167832
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 17, 2022
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: ApprovedProduct Type: Small molecule
Sponsor: Lupin Ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership September 06, 2021
Lead Product(s) : Pretomanid,Bedaquiline,Linezolid
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
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.
Brand Name : PA-824
Molecule Type : Small molecule
Upfront Cash : Undisclosed
September 06, 2021
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,Delamanid,Bedaquiline
Therapeutic Area: Infections and Infectious Diseases Brand Name: OPC-167832
Study Phase: Phase I/ Phase IIProduct Type: Small molecule
Sponsor: Bill & Melinda Gates Foundation
Deal Size: $17.8 million Upfront Cash: Undisclosed
Deal Type: Funding August 10, 2021
Lead Product(s) : OPC-167832,Delamanid,Bedaquiline
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).
Brand Name : OPC-167832
Molecule Type : Small molecule
Upfront Cash : Undisclosed
August 10, 2021
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: Pulmonary/Respiratory Diseases Brand Name: PA-824
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 03, 2020
Lead Product(s) : Pretomanid,Bedaquiline,Linezolid
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : PA-824
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 03, 2020
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: Pulmonary/Respiratory Diseases Brand Name: Undisclosed
Study Phase: ApprovedProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 27, 2020
Lead Product(s) : Bedaquiline
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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).
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
May 27, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATES SUPPLIERS
DKSH is your trusted partner for companies looking to grow their business in Asia & beyond.
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-...
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...
3-(Dimethylamino)-1-(naphthalen-1-yl)propan-1-one ...
CAS Number : CAS-5409-58-5
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...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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 : RX
Registration Country : USA
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
Regulatory Info : RX
Registration Country : USA
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
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
RLD : Yes
TE Code :
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 :
RLD : Yes
TE Code :
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 :
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]South Africa
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Related Excipient Companies
SPI Pharma
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
Grade : Oral
Application : Coating Systems & Additives
Excipient Details : ACTILLETS™ are microcrystalline cellulose spheres used in advanced drug formulations as starter cores for drug layering and coating.
Pharmacopoeia Ref : NA
Technical Specs : Bulk density: 0.80
Ingredient(s) : Microcrystalline Cellulose
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Tablet
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SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : CS90 is a directly compressible calcium carbonate with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-175, Tapped Density: 0.85
Ingredient(s) : Calcium Carbonate Excipient
SPI Pharma has been solving formulation challenges using superior functional materials.
Dosage Form : Orodispersible Tablet
Grade : Oral
Application : Chewable & Orodispersible Aids
Excipient Details : MS90 is a directly compressible magnesium hydroxide with starch used for chewable tablets due to its smooth mouthfeel and creamy texture.
Pharmacopoeia Ref : NA
Technical Specs : PSD D50: 150-170, Taped Density: 0.80
Ingredient(s) : Starch
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients by Applications
Fillers, Diluents & Binders
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Dosage Form : Capsule, Orodispersible Tablet, Tablet
Grade : Oral
Category : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
Brand Name : Croscarmellose Sodium
Application : Disintegrants & Superdisintegrants, Fillers, Diluents & Binders
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Grade : Oral
Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders
Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders
Excipient Details : STARLOSE is used as a diluent, binder, directly compressible (DC), and co-processed excipient in tablets and capsules.
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Grade : Oral
Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Thickeners and Stabilizers
Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders, Thickeners and Stabilizers
Excipient Details : DiCOM-DC SP204 is used as a stabilizer, filler, binder, directly compressible, and co-processed excipient in tablets and capsules.
Nanjing Well is focused on R&D, production & sales of Pharmaceutical Excipients & Synthetic Lubricating base oils.
Brand Name : Lactose Monohydrate
Application : Parenteral
Excipient Details : Lactose monohydrate is used as a diluent in inhalation and lyophilized preparations.
Dosage Form : Capsule, Granule / Pellet, Tablet
Grade : Oral
Category : Disintegrants & Superdisintegrants
Brand Name : Croscarmellose Sodium
Application : Disintegrants & Superdisintegrants
Excipient Details : Croscarmellose Sodium is used as a super disintegrant in various oral solid dosage forms such as tablets, capsules, and orodispersible tablets (ODTs).
Dosage Form : Capsule, Injectable / Parenteral, Tablet
Grade : Oral, Parenteral
Category : Fillers, Diluents & Binders, Parenteral
Brand Name : Lactose Monohydrate
Application : Fillers, Diluents & Binders, Parenteral
Excipient Details : Lactose Monohydrate is widely used as a filler and diluent in tablets and capsules and in the production of lyophilized and parenteral products.
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Grade : Oral
Category : Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Lubricants & Glidants
Application : Co-Processed Excipients, Direct Compression, Disintegrants & Superdisintegrants, Fillers, Diluents & Binders, Lubricants & Glidants
Excipient Details : ProBlend (Microcrystalline Cellulose) is used as a filler, binder, glidant, DC & co-processed excipient in tablets, capsules, and MUPS formulations.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Grade : Oral
Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders
Brand Name : DiCOM-DC® PL009 P60
Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders
Excipient Details : DiCOM-DC PL009 P60 is used as a filler, binder, directly compressible, and co-processed excipient in tablets and capsules.
Application : Fillers, Diluents & Binders
Excipient Details : Corn Starch is used as a filler and binder in pharmaceutical oral solid dosage forms including tablets and capsules.
Gangwal Healthcare is powered by innovation, driving health, wellness & healing.
Grade : Oral
Category : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders
Application : Co-Processed Excipients, Direct Compression, Fillers, Diluents & Binders
Excipient Details : DiCOM-DC S-Star (Maize Starch) is used as a filler, binder, and directly compressible co-processed excipient in tablets and capsules.
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