Synopsis
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1. Gs-ca1
1. Gs-6207
2. 2189684-44-2
3. Gs-hiv
4. Gs-ca2
5. Gs-ca-2
6. Lenacapavir [usan]
7. Gs-ca1
8. A9a0o6fb4h
9. Gs-714207
10. Gs6207
11. N-[(1s)-1-[3-[4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)indazol-7-yl]-6-(3-methyl-3-methylsulfonylbut-1-ynyl)pyridin-2-yl]-2-(3,5-difluorophenyl)ethyl]-2-[(2s,4r)-5,5-difluoro-9-(trifluoromethyl)-7,8-diazatricyclo[4.3.0.02,4]nona-1(6),8-dien-7-yl]acetamide
12. N-((s)-1-(3-(4-chloro-3-(methylsulfonamido)-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl)-6-(3-methyl-3-(methylsulfonyl)but-1-yn-1-yl)pyridin-2-yl)-2-(3,5-difluorophenyl)ethyl)-2-((3bs,4ar)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1h-cyclopropa[3,4]cyclopenta[1,2-c]pyrazol-1-yl)acetamide
13. N-[(1s)-1-(3-{4-chloro-3-[(methylsulfonyl)amino]-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl}-6-[3-methyl-3-(methylsulfonyl)but-1-yn-1-yl]pyridin-2-yl)-2-(3,5-difluorophenyl)ethyl]-2-[(3bs,4ar)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1h-cyclopropa[3,4]cyclopenta[1,2-c]pyrazol-1-yl]acetamide
14. Qng
15. Lenacapavir [inn]
16. Unii-a9a0o6fb4h
17. Lenacapavir [who-dd]
18. Chembl4594438
19. Schembl19875642
20. Gtpl11446
21. Ex-a5518
22. Who 11108
23. At20076
24. Hy-111964
25. Cs-0094695
26. 1h-cyclopropa(3,4)cyclopenta(1,2-c)pyrazole, N-((1s)-1-(3-(4-chloro-3-((methylsulfonyl)amino)-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl)-6-(3-methyl-3-(methylsulfonyl)-1-butyn-1-yl)-2-pyridinyl)-2-(3,5-difluorophenyl)ethyl)-5,5-difluoro-3b,4,4a,5-tetrahydro-3-(trifluoromethyl)-, (3bs,4ar)-
27. N-((1s)-1-(3-(4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)-1h-indazol-7-yl)-6-(3-(methanesulfonyl)-3-methylbut-1-yn-1-yl)pyridin-2-yl)-2-(3,5- Difluorophenyl)ethyl)-2-((3bs,4ar)-5,5-difluoro-3-(trifluoromethyl)-3b,4,4a,5-tetrahydro-1h-cyclopropa(3,4)cyclopenta(1,2-c)pyrazol-1-yl)acetamide
28. N-[(1s)-1-[3-[4-chloro-3-(methanesulfonamido)-1-(2,2,2-trifluoroethyl)indazol-7-yl]-6-(3-methyl-3-methylsulfonyl-but-1-ynyl)-2-pyridyl]-2-(3,5-difluorophenyl)ethyl]-2-[difluoro(trifluoromethyl)[?]yl]acetamide
Molecular Weight | 968.3 g/mol |
---|---|
Molecular Formula | C39H32ClF10N7O5S2 |
XLogP3 | 6.4 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 19 |
Rotatable Bond Count | 13 |
Exact Mass | 967.1435188 g/mol |
Monoisotopic Mass | 967.1435188 g/mol |
Topological Polar Surface Area | 175 Ų |
Heavy Atom Count | 64 |
Formal Charge | 0 |
Complexity | 2040 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 3 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Treatment of human immunodeficiency virus (HIV-1) infection
* Sunlenca injection: , in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen (see sections 4. 2 and 5. 1).
* Sunlenca tablet: , in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV 1 infection for whom it is otherwise not possible to construct a suppressive anti viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4. 2 and 5. 1).
J05AX
J - Antiinfectives for systemic use
J05 - Antivirals for systemic use
J05A - Direct acting antivirals
J05AX - Other antivirals
J05AX31 - Lenacapavir
NDC Package Code : 54014-6902
Start Marketing Date : 2022-12-22
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
NDC Package Code : 66721-830
Start Marketing Date : 2022-08-17
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (20kg/20kg)
Marketing Category : BULK INGREDIENT
2-((3bS,4aR)-5,5-Difluoro-3-(trifluoromethyl)-3b,4...
CAS Number : 1620056-83-8
End Use API : Lenacapavir
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
3-Methyl-3-(methylsulfonyl)but-1-yne
CAS Number : 2109226-54-0
End Use API : Lenacapavir
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
tert-butylN-[(1S)-1-(3,6-dibromopyridin-2-yl)-2-(3...
CAS Number : 1620056-47-4
End Use API : Lenacapavir
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
Carbamic acid, N-[(1S)-1-[3-bromo-6-[3-methyl-3-(...
CAS Number : 2189684-54-4
End Use API : Lenacapavir
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
4-Chloro-7-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan...
CAS Number : 2189684-53-3
End Use API : Lenacapavir
About The Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediate...
2-((3bS,4aR)-5,5-difluoro-3- (trifluoromethyl)-3b,...
CAS Number : 1620056-83-8
End Use API : Lenacapavir
About The Company : Porton Pharma Solutions Ltd. was founded in 2005, & the company's stock was successfully listed in Shenzhen Stock Exchange in 2014. Our R&D, manufacturing & ope...
CAS Number : 91-00-9
End Use API : Lenacapavir
About The Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pil...
CAS Number : 91-00-9
End Use API : Lenacapavir
About The Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pil...
4-Chloro-7-(4,4,5,5-tetramethyl-1,3,2-dioxaborolan...
CAS Number : 2189684-53-3
End Use API : Lenacapavir
About The Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide rang...
Tert-butyl (S)-[1-(3-bromo-6-[3-methyl-3-(methyl s...
CAS Number : 2189684-54-4
End Use API : Lenacapavir
About The Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide rang...
Regulatory Info : RX
Registration Country : USA
Brand Name : SUNLENCA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)
Packaging :
Approval Date : 2022-12-22
Application Number : 215973
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : SUNLENCA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 300MG BASE
Packaging :
Approval Date : 2022-12-22
Application Number : 215974
Regulatory Info : RX
Registration Country : USA
RLD : Yes
TE Code :
Brand Name : SUNLENCA
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : EQ 463.5MG BASE/1.5ML (EQ 309MG BASE/ML)
Approval Date : 2022-12-22
Application Number : 215973
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Brand Name : SUNLENCA
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 300MG BASE
Approval Date : 2022-12-22
Application Number : 215974
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
https://www.pharmacompass.com/radio-compass-blog/fda-s-drug-approvals-drop-26-due-to-covid-okays-three-costly-gene-therapies-in-h2
Patents & EXCLUSIVITIES
ABOUT THIS PAGE
A Lenacapavir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lenacapavir, including repackagers and relabelers. The FDA regulates Lenacapavir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lenacapavir API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Lenacapavir supplier is an individual or a company that provides Lenacapavir active pharmaceutical ingredient (API) or Lenacapavir finished formulations upon request. The Lenacapavir suppliers may include Lenacapavir API manufacturers, exporters, distributors and traders.
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 Lenacapavir as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lenacapavir 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 Lenacapavir 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 Lenacapavir and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lenacapavir NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lenacapavir suppliers with NDC on PharmaCompass.
Lenacapavir 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 Lenacapavir 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 Lenacapavir GMP manufacturer or Lenacapavir GMP API supplier for your needs.
A Lenacapavir CoA (Certificate of Analysis) is a formal document that attests to Lenacapavir's compliance with Lenacapavir specifications and serves as a tool for batch-level quality control.
Lenacapavir CoA mostly includes findings from lab analyses of a specific batch. For each Lenacapavir 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.
Lenacapavir may be tested according to a variety of international standards, such as European Pharmacopoeia (Lenacapavir EP), Lenacapavir JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lenacapavir USP).
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