Synopsis
Synopsis
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CEP/COS
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JDMF
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VMF
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EDQM
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USP
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JP
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Others
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Canada
DRUG PRODUCT COMPOSITIONS
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Data Compilation #PharmaFlow
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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.
L01XE
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36174
Submission : 2021-11-30
Status : Active
Type : II
NDC Package Code : 52076-6261
Start Marketing Date : 2018-10-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC Package Code : 52076-6203
Start Marketing Date : 2017-09-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-22
Pay. Date : 2020-10-09
DMF Number : 35288
Submission : 2020-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35027
Submission : 2020-09-10
Status : Inactive
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36174
Submission : 2021-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41518
Submission : 2025-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35027
Submission : 2020-09-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-18
Pay. Date : 2021-09-24
DMF Number : 36335
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41179
Submission : 2025-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-03
Pay. Date : 2020-09-25
DMF Number : 35098
Submission : 2020-09-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-22
Pay. Date : 2020-10-09
DMF Number : 35288
Submission : 2020-11-26
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41424
Submission : 2025-03-14
Status : Active
Type : II
Portfolio PDF
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Corporate PDF
Registrant Name : Novartis Korea Ltd.
Registration Date : 2019-10-28
Registration Number : 196-18-ND
Manufacturer Name : Novartis Grimsby Limited
Manufacturer Address : Moody Lane, Pyewipe, Grimsby, NE Lincolnshire, DN31 2SR, England
Registrant Name : Novartis Korea Ltd.
Registration Date : 2022-10-25
Registration Number : 196-25-ND
Manufacturer Name : Raybow(Suzhou) Pharmaceutica...
Manufacturer Address : 18 Tonglian Road, Bixi Subdistrict, Changshu City, Jiangsu Province 215537, China
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
About the Company : Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical indus...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutica...
About the Company : Arevipharma GmbH is a modern manufacturer of active pharmaceutical ingredients and intermediates with more than 140 years of expertise. Our customers are generic and research-based...
About the Company : Cdymax (India) Pharma Private Limited was founded in 1994. The company's line of business includes the manufacturing, fabricating, or processing of drugs in pharmaceutical preparat...
About the Company : Cipla is a global pharmaceutical company whose goal is ensuring no patient shall be denied access to high quality & affordable medicine and support. Mission: Cipla’s mission i...
About the Company : Globe Quimica S.A. is a major Brazilian API producer, GMP certificated by ANVISA, manufactures more than 20 different API's such as Antiretrovirals, Anxiolytic, Antidepressant, Ant...
Details:
AZD9833 (camizestrant) is an investigational, potent, next-generation oral SERD and ER antagonist that is currently being investigated for the treatment of HR-positive breast cancer.
Lead Product(s): Camizestrant,Palbociclib,Ribociclib
Therapeutic Area: Oncology Brand Name: AZD9833
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 26, 2025
Lead Product(s) : Camizestrant,Palbociclib,Ribociclib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Camizestrant Improves PFS in HR+ Breast Cancer SERENA-6
Details : AZD9833 (camizestrant) is an investigational, potent, next-generation oral SERD and ER antagonist that is currently being investigated for the treatment of HR-positive breast cancer.
Product Name : AZD9833
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 26, 2025
Details:
Kisqali (ribociclib) is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Lead Product(s): Ribociclib
Therapeutic Area: Oncology Brand Name: Kisqali
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 10, 2024
Lead Product(s) : Ribociclib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Kisqali® NATALEE Data Show Durable Reduction in Recurrence in Early Breast Cancer
Details : Kisqali (ribociclib) is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Product Name : Kisqali
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 10, 2024
Details:
Kisqali (ribociclib) is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Lead Product(s): Ribociclib
Therapeutic Area: Oncology Brand Name: Kisqali
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 27, 2024
Lead Product(s) : Ribociclib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Kisqali® Receives European Commission Approval for High-Risk Early Breast Cancer
Details : Kisqali (ribociclib) is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Product Name : Kisqali
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 27, 2024
Details:
Kisqali (ribociclib) is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Lead Product(s): Ribociclib
Therapeutic Area: Oncology Brand Name: Kisqali
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 18, 2024
Lead Product(s) : Ribociclib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Gets Positive CHMP Opinion for Kisqali® in Breast Cancer
Details : Kisqali (ribociclib) is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
Product Name : Kisqali
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 18, 2024
Details:
Kisqali-Generic (ribociclib) is a cyclin-dependent kinase 4/6 inhibitor, indicated in combination with aromatase inhibitor for HR-positive, HER2-negative advanced or metastatic breast cancer.
Lead Product(s): Ribociclib,Undisclosed
Therapeutic Area: Oncology Brand Name: Kisqali
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 17, 2024
Lead Product(s) : Ribociclib,Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Kisqali® to Reduce Recurrence in HR+/HER2- Breast Cancer
Details : Kisqali-Generic (ribociclib) is a cyclin-dependent kinase 4/6 inhibitor, indicated in combination with aromatase inhibitor for HR-positive, HER2-negative advanced or metastatic breast cancer.
Product Name : Kisqali
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 17, 2024
Details:
The net proceeds will be used to fund the clinical development of company's lead product OP-1250 (palazestrant), which is being evaluated for the treatment of ER+/HER2-metastatic breast cancer.
Lead Product(s): Palazestrant,Ribociclib
Therapeutic Area: Oncology Brand Name: OP-1250
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Adage Capital Partners
Deal Size: $250.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement February 12, 2024
Lead Product(s) : Palazestrant,Ribociclib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Adage Capital Partners
Deal Size : $250.0 million
Deal Type : Private Placement
Olema & Novartis Collaborate on Breast Cancer Trials, Raise $250M Equity Placement
Details : The net proceeds will be used to fund the clinical development of company's lead product OP-1250 (palazestrant), which is being evaluated for the treatment of ER+/HER2-metastatic breast cancer.
Product Name : OP-1250
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 12, 2024
Details:
Through collaboration, Novartis will provide Olema with ribociclib for the planned late-stage OP-1250 (palazestrant) trial with ribociclib in ER+/HER2-metastatic breast cancer.
Lead Product(s): Palazestrant,Ribociclib
Therapeutic Area: Oncology Brand Name: OP-1250
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration February 12, 2024
Lead Product(s) : Palazestrant,Ribociclib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Undisclosed
Deal Type : Collaboration
Olema & Novartis Collaborate on Breast Cancer Trials, Raise $250M Equity Placement
Details : Through collaboration, Novartis will provide Olema with ribociclib for the planned late-stage OP-1250 (palazestrant) trial with ribociclib in ER+/HER2-metastatic breast cancer.
Product Name : OP-1250
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 12, 2024
Details:
Kisqali-Generic (ribociclib) is a cyclin-dependent kinase 4/6 inhibitor, which is indicated for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
Lead Product(s): Ribociclib
Therapeutic Area: Oncology Brand Name: Kisqali-Generic
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 04, 2024
Lead Product(s) : Ribociclib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alembic Pharma Gets Tentative USFDA Nod for Breast Cancer Drug
Details : Kisqali-Generic (ribociclib) is a cyclin-dependent kinase 4/6 inhibitor, which is indicated for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer.
Product Name : Kisqali-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
February 04, 2024
Details:
Under the collaboration, Novartis will increase the size of the ongoing Phase 1/2 study testing OP-1250 (palazestrant), an orally-available small molecule with dual activity as both a complete ER antagonist and a selective ER degrader, in combination with ribociclib.
Lead Product(s): Palazestrant,Ribociclib
Therapeutic Area: Oncology Brand Name: OP-1250
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Novartis Pharmaceuticals Corporation
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Expanded Collaboration October 10, 2023
Lead Product(s) : Palazestrant,Ribociclib
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
Deal Size : Undisclosed
Deal Type : Expanded Collaboration
Olema Oncology Announces Expansion of Collaboration Agreement with Novartis
Details : Under the collaboration, Novartis will increase the size of the ongoing Phase 1/2 study testing OP-1250 (palazestrant), an orally-available small molecule with dual activity as both a complete ER antagonist and a selective ER degrader, in combination wit...
Product Name : OP-1250
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
October 10, 2023
Details:
Kisqali® (ribociclib) is the only USFDA approved category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an AI.
Lead Product(s): Ribociclib,Anastrozole
Therapeutic Area: Oncology Brand Name: Kisqali
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 27, 2023
Lead Product(s) : Ribociclib,Anastrozole
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Kisqali® Phase III NATALEE Trial Meets Primary Endpoint at Interim Analysis Demonstratin...
Details : Kisqali® (ribociclib) is the only USFDA approved category 1 preferred CDK4/6 inhibitor for first-line treatment of patients with HR+/HER2- MBC when combined with an AI.
Product Name : Kisqali
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 27, 2023
Tert-Butyl4-(6-aminopyridin-3-yl)piperazine-1 -car...
CAS Number : 571188-59-5
End Use API : Ribociclib
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
CAS Number : 39856-50-3
End Use API : Ribociclib
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
6-BROMO-2-CHLORO-8-CYCLOPENTYL-5-METHYLPYRIDO[2,3-...
CAS Number : 1016636-76-2
End Use API : Ribociclib
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
5-BROMO-2-CHLORO-N-CYCLOPENTYLPYRIMIDIN-4-AMINE
CAS Number : 733039-20-8
End Use API : Ribociclib
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
5-BROMO-2,4-DICHLOROPYRIMIDINE
CAS Number : 36082-50-5
End Use API : Ribociclib
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
1-BOC- 4-(6-NITRO-3-PYRIDYL)PIPERAZINE
CAS Number : 571189-16-7
End Use API : Ribociclib
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
1-BOC- 4-(6-AMINO-3-PYRIDYL)PIPERAZINE
CAS Number : 571188-59-5
End Use API : Ribociclib
About The Company : Founded with a mission to transform strategic capital into specialty chemicals, Ami Group focuses on Agrochemicals, Cosmetics, and Polymers. Ami Organics Ltd. i...
2-Chloro-7-cyclopentyl-N,N-dimethyl-7H-pyrrolo[2,3...
CAS Number : 1211443-61-6
End Use API : Ribociclib
About The Company : We are into manufacturing of bulk drug Intermediates and Active Pharmaceutical Ingredients (API). Our core competence is contract manufacturing for our clients ...
Tert-Butyl 4-(6-aminopyridin-3-yl)piperazine-1-car...
CAS Number : 571188-59-5
End Use API : Ribociclib
About The Company : Aventus Labs is a forward-thinking pharmaceutical company committed to developing and delivering high-quality, effective healthcare solutions. With a focus on r...
2-chloro-7-cyclopentyl-N,N-dimethyl-7H-pyrrolo[2,3...
CAS Number : 1211443-61-6
End Use API : Ribociclib
About The Company : Royal pharma was started in 2007 – it’s a small scale Advanced Intermediates Manufacturing company. Facilities are in accordance to GMP standards. Currently...
RLD :
TE Code :
Brand Name : RIBOCICLIB
Dosage Form : TABLET; ORAL
Dosage Strength : 200MG
Approval Date :
Application Number : 215677
RX/OTC/DISCN :
RLD :
TE Code :
RLD : Yes
TE Code :
Brand Name : KISQALI
Dosage Form : TABLET;ORAL
Dosage Strength : EQ 200MG BASE
Approval Date : 2017-03-13
Application Number : 209092
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
LETROZOLE; RIBOCICLIB SUCCINATE
Brand Name : KISQALI FEMARA CO-PACK (COPACKAGED)
Dosage Form : TABLET;ORAL
Dosage Strength : 2.5MG;EQ 200MG BASE
Approval Date : 2017-05-04
Application Number : 209935
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
Related Excipient Companies
Dosage Form : Tablet
Grade : Oral
Application : Fillers, Diluents & Binders
Excipient Details : It is used as a filler in formulation.
Pharmacopoeia Ref : Not Available
Technical Specs : Also Available as Comprecel M102, M102CG, M103, M105, M124, M113, M200, M224, M301, M302
Ingredient(s) : Microcrystalline Cellulose
Dosage Form : Tablet
Grade : Oral
Application : Lubricants & Glidants
Excipient Details : It is used as a lubricant.
Pharmacopoeia Ref : Not Available
Technical Specs : Not Available
Ingredient(s) : Magnesium Stearate
Excipients by Applications
https://www.pharmacompass.com/pipeline-prospector-blog/biotech-indices-inch-up-post-svb-bloodbath-covid-drugmakers-report-drop-in-q1-sales
28 Mar 2025
// PRESS RELEASE
https://www.suanfarma.com/apis-3/targeting-breast-cancer-with-precision-ribociclib-succinate-a-leading-cdk-4-6-inhibitor/
10 Dec 2024
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/longer-term-novartis-kisqali-natalee-data-show-durable-reduction-in-distant-recurrence-in-broad-population-of-patients-with-early-breast-cancer-302327614.html
10 Dec 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/12/10/2994578/0/en/Longer-term-Novartis-Kisqali-NATALEE-data-show-durable-reduction-in-distant-recurrence-in-broad-population-of-patients-with-early-breast-cancer.html
10 Dec 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/12/10/2994354/0/en/Olema-Oncology-Presents-Updated-Clinical-Results-for-Palazestrant-in-Combination-with-Ribociclib-at-the-San-Antonio-Breast-Cancer-Symposium.html
27 Nov 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/11/27/2987957/0/en/Novartis-Kisqali-receives-European-Commission-approval-in-a-broad-population-of-patients-with-HR-HER2-early-breast-cancer-at-high-risk-of-recurrence.html
25 Nov 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/11/25/2987118/0/en/Olema-Oncology-to-Present-New-Data-Combining-Palazestrant-with-Ribociclib-at-the-San-Antonio-Breast-Cancer-Symposium.html
Global Sales Information
Company :
Ribociclib Succinate
Drug Cost (USD) : 166,342,358
Year : 2022
Prescribers : 2108
Prescriptions : 11958
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Company :
Ribociclib Succinate
Drug Cost (USD) : 119,293,640
Year : 2021
Prescribers : 1435
Prescriptions : 9277
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Company :
Ribociclib Succinate
Drug Cost (USD) : 128,739,776
Year : 2020
Prescribers : 1623
Prescriptions : 10654
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Company :
Ribociclib Succinate
Drug Cost (USD) : 91,963,508
Year : 2019
Prescribers : 1487
Prescriptions : 7989
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Company :
Ribociclib Succinate
Drug Cost (USD) : 56,743,154
Year : 2018
Prescribers : 1077
Prescriptions : 5264
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Company :
Ribociclib Succinate
Drug Cost (USD) : 24,506,783
Year : 2017
Prescribers : 672
Prescriptions : 2323
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Company :
Ribociclib Succinate
Drug Cost (USD) : 0
Year : 2016
Prescribers :
Prescriptions : 0
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Corporate PDF
Company :
Ribociclib Succinate
Drug Cost (USD) : 0
Year : 2015
Prescribers :
Prescriptions : 0
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Dosage Form : Tabl
Dosage Strength : 200mg
Price Per Pack (Euro) : 924.1
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Tabl
Dosage Strength : 200mg
Price Per Pack (Euro) : 1584.53
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Dosage Form : Tabl
Dosage Strength : 200mg
Price Per Pack (Euro) : 2197.23
Published in :
Country : Switzerland
RX/OTC/DISCN : Class A
Main Therapeutic Indication : Oncology
Currency : USD
2020 Revenue in Millions : 687
2019 Revenue in Millions : 480
Growth (%) : 43
Main Therapeutic Indication : Oncology
Currency : USD
2021 Revenue in Millions : 937
2020 Revenue in Millions : 687
Growth (%) : 36
Main Therapeutic Indication : Oncology
Currency : USD
2022 Revenue in Millions : 1,231
2021 Revenue in Millions : 937
Growth (%) : 31
Main Therapeutic Indication : Oncology
Currency : USD
2023 Revenue in Millions : 2,080
2022 Revenue in Millions : 1,231
Growth (%) : 69
Main Therapeutic Indication : Oncology
Currency : USD
2017 Revenue in Millions : 76
2016 Revenue in Millions : 0
Growth (%) : New Launch
Main Therapeutic Indication : Oncology
Currency : USD
2018 Revenue in Millions : 235
2017 Revenue in Millions : 76
Growth (%) : 209%
Main Therapeutic Indication : Oncology
Currency : USD
2019 Revenue in Millions : 480
2018 Revenue in Millions : 235
Growth (%) : 104
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Patents & EXCLUSIVITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Ribociclib 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 Ribociclib manufacturer or Ribociclib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ribociclib manufacturer or Ribociclib supplier.
PharmaCompass also assists you with knowing the Ribociclib API Price utilized in the formulation of products. Ribociclib API Price is not always fixed or binding as the Ribociclib Price is obtained through a variety of data sources. The Ribociclib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ribociclib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ribociclib, including repackagers and relabelers. The FDA regulates Ribociclib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ribociclib 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ribociclib supplier is an individual or a company that provides Ribociclib active pharmaceutical ingredient (API) or Ribociclib finished formulations upon request. The Ribociclib suppliers may include Ribociclib API manufacturers, exporters, distributors and traders.
click here to find a list of Ribociclib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ribociclib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ribociclib active pharmaceutical ingredient (API) in detail. Different forms of Ribociclib DMFs exist exist since differing nations have different regulations, such as Ribociclib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ribociclib DMF submitted to regulatory agencies in the US is known as a USDMF. Ribociclib USDMF includes data on Ribociclib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ribociclib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ribociclib suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ribociclib Drug Master File in Korea (Ribociclib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ribociclib. The MFDS reviews the Ribociclib KDMF as part of the drug registration process and uses the information provided in the Ribociclib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ribociclib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ribociclib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ribociclib suppliers with KDMF on PharmaCompass.
A Ribociclib written confirmation (Ribociclib WC) is an official document issued by a regulatory agency to a Ribociclib manufacturer, verifying that the manufacturing facility of a Ribociclib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ribociclib APIs or Ribociclib finished pharmaceutical products to another nation, regulatory agencies frequently require a Ribociclib WC (written confirmation) as part of the regulatory process.
click here to find a list of Ribociclib 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 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ribociclib 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 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 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ribociclib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ribociclib suppliers with NDC on PharmaCompass.
Ribociclib 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 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 GMP manufacturer or Ribociclib GMP API supplier for your needs.
A Ribociclib CoA (Certificate of Analysis) is a formal document that attests to Ribociclib's compliance with Ribociclib specifications and serves as a tool for batch-level quality control.
Ribociclib CoA mostly includes findings from lab analyses of a specific batch. For each Ribociclib 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Ribociclib EP), Ribociclib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ribociclib USP).