Synopsis
Synopsis
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CEP/COS
0
JDMF
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KDMF
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VMF
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Canada
DRUG PRODUCT COMPOSITIONS
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EDQM
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USP
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JP
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Weekly News Recap #Phispers
1. Kisqali
2. Lee011
3. Ribociclib
1. Lee011 Succinate
2. 1374639-75-4
3. Lee-011 Succinate
4. Lee011-bba
5. Ribociclib Succinate [usan]
6. Kisqali
7. Lee-011-bba
8. Bg7hlx2919
9. 7-cyclopentyl-n,n-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide Succinate
10. Butanedioic Acid;7-cyclopentyl-n,n-dimethyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrrolo[2,3-d]pyrimidine-6-carboxamide
11. Ribociclib Succinate (usan)
12. Butanedioic Acid, Compd. With 7-cyclopentyl-n,n-dimethyl-2-((5-(1-piperazinyl)-2-pyridinyl)amino)-7h-pyrrolo(2,3-d)pyrimidine-6-carboxamide (1:1)
13. Butanedioic Acid, Compd. With 7-cyclopentyl-n,n-dimethyl-2-[[5-(1-piperazinyl)-2-pyridinyl]amino]-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1:1)
14. Unii-bg7hlx2919
15. Kisqali (tn)
16. Lee011 (succinate)
17. Birociclib [who-dd]
18. Schembl2684999
19. Chembl3707266
20. Ribociclib Succinate [mi]
21. Dtxsid301027923
22. Amy25508
23. Bcp12715
24. Ex-a1586
25. Zec63975
26. Lee011 Succinatelee011 Succinate
27. Hy-15777b
28. S5188
29. Ribociclib Succinate [who-dd]
30. Sb18482
31. Ac-30654
32. As-75241
33. Ribociclib Succinate [orange Book]
34. D10979
35. Lee-011 Succinate Salt, Ribociclib Succinate Salt
36. J-007026
37. Q27274660
38. Kisqali Femara Co-pack Component Ribociclib Succinate
39. Ribociclib Succinate Component Of Kisqali Femara Co-pack
40. 7-cyclopentyl-n,n-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide; Butanedioic Acid
Molecular Weight | 552.6 g/mol |
---|---|
Molecular Formula | C27H36N8O5 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 8 |
Exact Mass | 552.28086628 g/mol |
Monoisotopic Mass | 552.28086628 g/mol |
Topological Polar Surface Area | 166 Ų |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 728 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | KISQALI |
Active Ingredient | RIBOCICLIB SUCCINATE |
Company | NOVARTIS PHARMS CORP (Application Number: N209092. Patents: 8324225, 8415355, 8685980, 8962630, 9193732, 9416136, 9868739) |
2 of 2 | |
---|---|
Drug Name | KISQALI FEMARA CO-PACK (COPACKAGED) |
Active Ingredient | LETROZOLE; RIBOCICLIB SUCCINATE |
Company | NOVARTIS PHARMS CORP (Application Number: N209935. Patents: 8324225, 8415355, 8685980, 8962630, 9193732, 9416136, 9868739) |
Kisqali is indicated for the treatment of women with hormone receptor (HR)positive, human epidermal growth factor receptor 2 (HER2)negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
In pre or perimenopausal women, the endocrine therapy should be combined with a luteinising hormonereleasing hormone (LHRH) agonist.
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ABOUT THIS PAGE
A Ribociclib Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ribociclib Succinate, including repackagers and relabelers. The FDA regulates Ribociclib Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ribociclib Succinate 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 Ribociclib Succinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ribociclib Succinate supplier is an individual or a company that provides Ribociclib Succinate active pharmaceutical ingredient (API) or Ribociclib Succinate finished formulations upon request. The Ribociclib Succinate suppliers may include Ribociclib Succinate API manufacturers, exporters, distributors and traders.
click here to find a list of Ribociclib Succinate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ribociclib Succinate DMF (Drug Master File) is a document detailing the whole manufacturing process of Ribociclib Succinate active pharmaceutical ingredient (API) in detail. Different forms of Ribociclib Succinate DMFs exist exist since differing nations have different regulations, such as Ribociclib Succinate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ribociclib Succinate DMF submitted to regulatory agencies in the US is known as a USDMF. Ribociclib Succinate USDMF includes data on Ribociclib Succinate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ribociclib Succinate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ribociclib Succinate suppliers with USDMF on PharmaCompass.
A Ribociclib Succinate written confirmation (Ribociclib Succinate WC) is an official document issued by a regulatory agency to a Ribociclib Succinate manufacturer, verifying that the manufacturing facility of a Ribociclib Succinate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ribociclib Succinate APIs or Ribociclib Succinate finished pharmaceutical products to another nation, regulatory agencies frequently require a Ribociclib Succinate WC (written confirmation) as part of the regulatory process.
click here to find a list of Ribociclib Succinate 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 Ribociclib Succinate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ribociclib Succinate 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 Ribociclib Succinate 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 Ribociclib Succinate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ribociclib Succinate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ribociclib Succinate suppliers with NDC on PharmaCompass.
Ribociclib Succinate 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 Ribociclib Succinate 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 Ribociclib Succinate GMP manufacturer or Ribociclib Succinate GMP API supplier for your needs.
A Ribociclib Succinate CoA (Certificate of Analysis) is a formal document that attests to Ribociclib Succinate's compliance with Ribociclib Succinate specifications and serves as a tool for batch-level quality control.
Ribociclib Succinate CoA mostly includes findings from lab analyses of a specific batch. For each Ribociclib Succinate 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.
Ribociclib Succinate may be tested according to a variety of international standards, such as European Pharmacopoeia (Ribociclib Succinate EP), Ribociclib Succinate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ribociclib Succinate USP).
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