Synopsis
Synopsis
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CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
Europe
0
South Africa
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1. Myk-461
1. Camzyos
2. 1642288-47-8
3. Mavacamten [inn]
4. Mavacamten [usan]
5. Mavacamten [who-dd]
6. Myk-461
7. 6-[[(1s)-1-phenylethyl]amino]-3-propan-2-yl-1h-pyrimidine-2,4-dione
8. Qx45b99r3j
9. Sar-439152
10. (s)-3-isopropyl-6-((1-phenylethyl)amino)pyrimidine-2,4(1h,3h)-dione
11. Sar439152
12. 2,4(1h,3h)-pyrimidinedione, 3-(1-methylethyl)-6-(((1s)-1-phenylethyl)amino)-
13. 2,4(1h,3h)-pyrimidinedione, 3-(1-methylethyl)-6-[[(1s)-1-phenylethyl]amino]-
14. Mavacamten (myk-461)
15. Unii-qx45b99r3j
16. Myk461
17. Chembl4297517
18. Schembl16320785
19. Gtpl11265
20. Ex-a2072
21. Bdbm50575174
22. S8861
23. Who 10492
24. Db14921
25. Myk-461; Mavacamten; Sar439152
26. Sar-439152; Myk-461
27. Hy-109037
28. Cs-0031211
29. E83742
30. (s)-3-isopropyl-6-((1-phenylethyl)amino) Pyrimidine-2,4(1h,3h)-dione
31. (s)-3-isopropyl-6-((1-phenylethyl)amino)pyrimidine-2, 4(1h,3h)-dione
32. (s)-3-isopropyl-6-(1-phenylethylamino)pyrimidine-2,4(1h,3h)-dione
33. 3-(1-methylethyl)-6-[[(1s)-1-phenylethyl]amino]-2,4(1h,3h)-pyrimidinedione
34. 6-(((1s)-1-phenylethyl)amino)-3-(propan-2-yl)-1,2,3,4 Tetrahydropyrimidine-2,4-dione
35. 6-{[(1s)-1-phenylethyl]amino}-3-(propan-2-yl)pyrimidine-2,4(1h,3h)-dione
Molecular Weight | 273.33 g/mol |
---|---|
Molecular Formula | C15H19N3O2 |
XLogP3 | 2.1 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 3 |
Rotatable Bond Count | 4 |
Exact Mass | 273.147726857 g/mol |
Monoisotopic Mass | 273.147726857 g/mol |
Topological Polar Surface Area | 61.4 Ų |
Heavy Atom Count | 20 |
Formal Charge | 0 |
Complexity | 411 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Treatment of hypertrophic cardiomyopathy
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38462
Submission : 2023-06-22
Status : Active
Type : II
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
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Tagoor's product development expertise, backed by our comprehensive understanding of the processes, helps us offer high-quality APIs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Maithri Drugs: Delivering Trusted, High-Quality APIs to 35+ Countries with Innovation, Compliance, and Excellence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39772
Submission : 2024-03-29
Status : Active
Type : II
Available Reg Filing : BR |
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PharmaCompass offers a list of Mavacamten 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 Mavacamten manufacturer or Mavacamten supplier for your needs.
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A QX45B99R3J manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of QX45B99R3J, including repackagers and relabelers. The FDA regulates QX45B99R3J manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. QX45B99R3J API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A QX45B99R3J DMF (Drug Master File) is a document detailing the whole manufacturing process of QX45B99R3J active pharmaceutical ingredient (API) in detail. Different forms of QX45B99R3J DMFs exist exist since differing nations have different regulations, such as QX45B99R3J USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A QX45B99R3J DMF submitted to regulatory agencies in the US is known as a USDMF. QX45B99R3J USDMF includes data on QX45B99R3J's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The QX45B99R3J USDMF is kept confidential to protect the manufacturer’s intellectual property.
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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 QX45B99R3J as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for QX45B99R3J 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 QX45B99R3J 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 QX45B99R3J and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a QX45B99R3J NDC to their finished compounded human drug products, they may choose to do so.
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QX45B99R3J 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 QX45B99R3J 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 QX45B99R3J GMP manufacturer or QX45B99R3J GMP API supplier for your needs.
A QX45B99R3J CoA (Certificate of Analysis) is a formal document that attests to QX45B99R3J's compliance with QX45B99R3J specifications and serves as a tool for batch-level quality control.
QX45B99R3J CoA mostly includes findings from lab analyses of a specific batch. For each QX45B99R3J 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.
QX45B99R3J may be tested according to a variety of international standards, such as European Pharmacopoeia (QX45B99R3J EP), QX45B99R3J JP (Japanese Pharmacopeia) and the US Pharmacopoeia (QX45B99R3J USP).