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Chemistry

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Also known as: Lee011 succinate, 1374639-75-4, Lee-011 succinate, Lee011-bba, Ribociclib succinate [usan], Kisqali
Molecular Formula
C27H36N8O5
Molecular Weight
552.6  g/mol
InChI Key
NHANOMFABJQAAH-UHFFFAOYSA-N
FDA UNII
BG7HLX2919

Ribociclib
1 2D Structure

Ribociclib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
butanedioic acid;7-cyclopentyl-N,N-dimethyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrrolo[2,3-d]pyrimidine-6-carboxamide
2.1.2 InChI
InChI=1S/C23H30N8O.C4H6O4/c1-29(2)22(32)19-13-16-14-26-23(28-21(16)31(19)17-5-3-4-6-17)27-20-8-7-18(15-25-20)30-11-9-24-10-12-30;5-3(6)1-2-4(7)8/h7-8,13-15,17,24H,3-6,9-12H2,1-2H3,(H,25,26,27,28);1-2H2,(H,5,6)(H,7,8)
2.1.3 InChI Key
NHANOMFABJQAAH-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CN(C)C(=O)C1=CC2=CN=C(N=C2N1C3CCCC3)NC4=NC=C(C=C4)N5CCNCC5.C(CC(=O)O)C(=O)O
2.2 Other Identifiers
2.2.1 UNII
BG7HLX2919
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Kisqali

2. Lee011

3. Ribociclib

2.3.2 Depositor-Supplied Synonyms

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

2.4 Create Date
2012-06-20
3 Chemical and Physical Properties
Molecular Weight 552.6 g/mol
Molecular Formula C27H36N8O5
Hydrogen Bond Donor Count4
Hydrogen Bond Acceptor Count11
Rotatable Bond Count8
Exact Mass552.28086628 g/mol
Monoisotopic Mass552.28086628 g/mol
Topological Polar Surface Area166 Ų
Heavy Atom Count40
Formal Charge0
Complexity728
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameKISQALI
Active IngredientRIBOCICLIB SUCCINATE
CompanyNOVARTIS PHARMS CORP (Application Number: N209092. Patents: 8324225, 8415355, 8685980, 8962630, 9193732, 9416136, 9868739)

2 of 2  
Drug NameKISQALI FEMARA CO-PACK (COPACKAGED)
Active IngredientLETROZOLE; RIBOCICLIB SUCCINATE
CompanyNOVARTIS PHARMS CORP (Application Number: N209935. Patents: 8324225, 8415355, 8685980, 8962630, 9193732, 9416136, 9868739)

4.2 Drug Indication

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.


5 Pharmacology and Biochemistry
5.1 ATC Code

L01XE


API SUPPLIERS

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Egis Pharmaceuticals PLC

Hungary

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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02

Suanfarma

Spain

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothSuanfarma, at the Core of a Better Life.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Suanfarma

03

Aarti Pharmalabs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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Chunghwa Chemical Synthesis & Biot...

Taiwan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
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  • WHO-GMP

Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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TAPI Technology & API Services

Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Chunghwa Chemical Synthesis & Biot...

Taiwan

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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USDMF CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
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Teva Pharmaceutical Industries

Israel

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Teva Pharmaceutical Industries

Israel

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Fresenius Kabi Oncology Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Fresenius Kabi Oncology Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Hetero Drugs

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Cipla

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Cipla

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF

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Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 36174

Submission : 2021-11-30

Status : Active

Type : II

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Arvo
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Arvo
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Arvo
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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

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Arvo
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Tapi Nl Bv

Israel

USDMF

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Tapi Nl Bv

Israel
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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

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Valary Lab Private Ltd

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USDMF

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Valary Lab Private Ltd

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41424

Submission : 2025-03-14

Status : Active

Type : II

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KDMF

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Bioequity Europe
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Ribociclib Succinate

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

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Bioequity Europe
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Ribociclib Succinate

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

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Listed Suppliers

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Virtual BoothEgis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Ribociclib

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...

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 products under Egis’ brand names in 18 countries. In total, the company’s APIs & finished products reach 100 countries. Egis’ focus lies on treating diseases of cardiovascular & central nervous systems; however, it also provides modern treatment solutions in the fields of diabetology, dermatology & wound care. Our research and development activities focus on high-quality, value-added branded generic products. From 2023, Egis offers its CDMO & CMO services as well.
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Suanfarma

Spain
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Virtual BoothSuanfarma, at the Core of a Better Life.

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Ribociclib

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...

Suanfarma founded in 1993, is a B2B life science partner committed to health advancement by developing, manufacturing, & distributing high-quality APIs for the pharmaceutical industry innovatively & sustainably. Backed by a robust global network of 12 strategically located local offices, we cater to the needs of over 400 active customers in 70+ countries. At Suanfarma we offer our CDMO capacity for fermentation & chemical synthesis projects, offering a One Stop Shop service with a solid track record, & which allows us to achieve success in the development, scaling, manufacturing, & commercialization of an API, either innovative or generic.
Suanfarma

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Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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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, corticosteroids, cyto...

Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cytotoxic & oncology products. It has 2 R&D centers & 3 cGMP plants successfully audited by the USFDA, EUGMP, EDQM, KFDA & COFEPRIS. It offers CDMO services for generic APIs & NCEs, intermediates & key building blocks.Note: None of the products will be supplied to countries in which this could be in conflict with existing patents. Further, any products under patent will be offered for R&D purposes only. However, the final responsibility lies with the buyer
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04

  • fda
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Virtual BoothChunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.

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Ribociclib

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...

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 Asia to receive FDA approval for synthetic and biotech APIs, CCSB has a proven track record of commercializing Statin, Immunosuppressant, Muscle Relaxant, and ACE Inhibitor APIs, all with complete DMF or COS. For years, CCSB has partnered with leading brand and generic drug companies to develop and produce APIs and advanced intermediates, focusing on specialty APIs crafted through a sophisticated fusion of fermentation and synthesis technologies in Taiwan.
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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Ribociclib

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...

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, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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06

CST
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Ribociclib

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...

Alembic Pharmaceuticals Limited is a leading pharmaceutical company in India. The Company is vertically integrated with the ability to develop, manufacture and market pharmaceutical products, pharmaceutical substances and Intermediates.
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Arevipharma

Germany
CST
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Arevipharma

Germany
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Ribociclib

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...

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 pharmaceutical companies on five continents. Our business partners recognise us as a competent, reliable and efficient company that is distinguished by individual service and an innovative character. The company’s 140 year history is based on the knowledge, skills, commitment and loyalty of its employees. Arevipharma also feels committed to its owners and investors. Due to the consistent expansion of new technologies,
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Cdymax

India
CST
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Cdymax

India
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Ribociclib

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...

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 preparations for human or veterinary use.CDYMAX ensures and adherence to HSE practices. System and procedures are in place to control and monitoring. All employees under go periodic health check-up once in a year and twice in a year for oncology employees. Effluent treatment plant meeting Government regulation.
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Cipla

India
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Cipla

India
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Ribociclib succinate

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...

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 is to be a leading global healthcare company which uses technology and innovation to meet everyday needs of all patients. Since inception in 1935, caring has been at the core of everything we do at Cipla. For patients, caring is a promise that we will do whatever it takes to ensure they have continued access to the highest quality medicines at affordable prices; whether a disease affects millions or just a few hundreds.
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CST
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Ribociclib

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...

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, Antithrombotic, Analgesic. In 2012 Globe Quimica has started-up its new API plant for Active Ingredients for Oncologic Drugs.
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Drugs in Development

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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

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AstraZeneca

United Kingdom
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AstraZeneca

United Kingdom
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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

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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

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PEGS Boston Summit
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PEGS Boston Summit
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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

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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

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
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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

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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

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04

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

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

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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

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

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

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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

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

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

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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

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

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

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

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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

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

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

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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

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PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

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

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

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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

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10

PEGS Boston Summit
Not Confirmed
PEGS Boston Summit
Not Confirmed

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

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INTERMEDIATE SUPPLIERS

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01

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  • EDQM
  • WHO-GMP

Virtual BoothAarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.

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...

Aarti Industries Company Banner

02

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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...

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China Battery Fair
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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...

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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...

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05

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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...

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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...

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China Battery Fair
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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...

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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 ...

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09

Aventus Labs

India
China Battery Fair
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Aventus Labs

India
China Battery Fair
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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...

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Royal Pharma

India
China Battery Fair
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Royal Pharma

India
China Battery Fair
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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...

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FDA Orange Book

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RIBOCICLIB

Brand Name : RIBOCICLIB

Dosage Form : TABLET; ORAL

Dosage Strength : 200MG

Approval Date :

Application Number : 215677

RX/OTC/DISCN :

RLD :

TE Code :

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02

NOVARTIS

Switzerland
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NOVARTIS

Switzerland
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RIBOCICLIB SUCCINATE

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 :

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NOVARTIS

Switzerland
China Battery Fair
Not Confirmed
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NOVARTIS

Switzerland
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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 :

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STOCK RECAP #PipelineProspector

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Biotech indices inch up post SVB bloodbath; Covid drugmakers report drop in Q1 sales
In March, the collapse of Silicon Valley Bank (SVB) had dragged the biotech indices down. SVB had made considerable investments in the biotech space, and its downfall had left many life sciences and healthcare companies vulnerable.Within a month of the SVB storm, biotech indices have bounced back. The Nasdaq Biotechnology Index (NBI) gained 1 percent to end April at US$ 4,187.32. It was down 1.3 percent in March. The S&P Biotechnology Select Industry Index (SPSIBI) was up 2 percent at US$ 6,094.82, and the SPDR S&P Biotech ETF (XBI) increased 4 percent to US$ 80.20. Both SPSIBI and XBI had dropped by 8.3 percent and 8.2 percent, respectively, in March.In April, several drugmakers announced their first quarter (Q1) results. The month also saw three major M&A deals — Merck’s US$ 10.8 billion buyout of Prometheus Biosciences, Astellas Pharma’s US$ 5.9 billion acquisition of Iveric Bio and GSK’s US$ 2 billion deal to buy Bellus Health.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Pfizer reports 29% drop in Q1 revenues, falls behind GSK in RSV vaccine raceWe have seen this happening for many months now, with Pfizer’s stock consistently falling since January. The Q1 results only echoed that sentiment — Pfizer’s revenues fell 29 percent to US$ 18.3 billion due to a 77 percent drop in sales of its Covid-19 vaccine Comirnaty. This led to a further 5 percent drop in the drug behemoth’s stock in April. What was going right for Pfizer was its experimental respiratory syncytial virus (RSV) vaccine. But GSK raced ahead of Pfizer this month when the US Food and Drug Administration (FDA) approved its RSV vaccine — Arexvy — for adults aged 60 years and older. The Prescription Drug User Fee Act (PDUFA) date for the Pfizer jab for older adults is this month too. GSK also announced the acquisition of Canada-based drug developer Bellus Health (up 114 percent) for US$ 2 billion.Among other Covid drugmakers, Moderna’s stock also suffered a 17 percent loss last month. What was worse, its experimental messenger RNA-based influenza vaccine failed to demonstrate effectiveness against influenza B. Moderna is planning to go ahead with a phase 3 study of mRNA-4157 (its investigational individualized neo-antigen therapy) and Keytruda combo in patients with adjuvant melanoma this year.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel) Wegovy helps boost Novo’s Q1 revenues; Vabysmo brings gains for RocheIn April, both Novo Nordisk and Eli Lilly posted gains in the bourses. Wegovy’s success in the US helped Novo’s obesity care segment notch up a 131 percent increase in Q1 sales. Novo’s diabetes and obesity drug sales rose 33 percent and were at DKK 48.8 billion (US$ 7.11 billion). Overall, the Danish drugmaker posted an impressive 27 percent growth in its Q1 sales — which were at DKK 53.4 billion (US$ 7.7 billion) — while its stock rose 5 percent in April.Lilly is seeking to compete with Wegovy’s dominance in the obesity market with its own drug, Mounjaro. It recently posted favorable data from a late-stage trial, where Mounjaro achieved 21 percent weight reduction in non-diabetic patients, compared to 15 percent for Wegovy. Lilly is now conducting another Phase 3b trial to test Mounjaro against Wegovy. And in a separate trial, Mounjaro led to a 16 percent weight loss in patients with type 2 diabetes. The drugmaker‘s stock rose by a handsome 15 percent.Roche Group’s pharmaceutical division posted 9 percent growth in Q1 sales — at CHF 11.7 billion (US$ 12.7 billion) — due to strong demand for newer medicines. Eye diseases drug Vabysmo, approved last year, turned out to be the strongest growth driver, generating CHF 432 million (US$ 486 million) in global sales. Roche expects the drug to generate US$ 2 billion in revenue this year. The Swiss drugmaker also shared post-hoc analyses from four additional phase 3 studies showing Vabysmo to be more effective at drying retinal fluid than Regeneron’s Eylea in Age-related macular degeneration (AMD) and Diabetic Macular Edema (DME). Roche’s stock gained 11 percent.In addition, FDA approved Roche’s Polivy as part of a five-drug combination for previously untreated diffuse large B-cell lymphoma (DLBCL), the first new treatment in nearly 20 years to significantly improve outcomes in first-line DLBCL. In Q1, Roche reported a decline of 3 percent in group sales due to lower demand for Covid tests.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Higher sales of key drugs take Novartis’ Q1 sales up 8%; J&J lowers 2023 guidanceNovartis’ Q1 sales grew 8 percent to US$ 12.95 billion, driven by strong performance of its heart failure drug Entresto, cancer meds Pluvicto and Kisqali, and multiple sclerosis drug Kesimpta. Based on higher Q1 sales, the Swiss drugmaker has raised its outlook for 2023.Novartis and partner BeiGene’s experimental drug tislelizumab showed promising results in treating certain types of gastric cancer in a late-stage trial. The partners hope this data will help make tislelizumab the first-line therapy for patients with advanced forms of gastric cancer. While Novartis’ stock went up 11 percent, BeiGene’s stock gained 17 percent in April.Though J&J’s Q1 results exceeded analyst expectations, the drugmaker lowered the 2023 guidance for its pharmaceutical business. Leaked data from a phase 3 trial showed that J&J and Legend’s cancer drug Carvykti performed better-than-expected in patients with multiple myeloma. J&J’s stock went up 4 percent. Legend’s stock rose 46 percent.Among small cap companies, Madrigal’s stock rose 24 percent in April on news of a breakthrough therapy designation for its drug Resmetirom as a treatment for nonalcoholic steatohepatitis.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Merck acquires Prometheus for US$ 10.8 bn; Astellas buys Iveric Bio for US$ 5.9 bnApril proved to be a good month for both Merck and AstraZeneca, even though the two drugmakers reported a drop in their Q1 revenues due to decreased sales of their Covid-19 products.While Merck reported a 9 percent drop in Q1 sales (at US$ 14.5 billion), with sales of its Covid-19 antiviral pill Lagevrio (molnupiravir) dropping 88 percent, Astra reported a 4 percent decrease in revenue (at US$ 10.88 billion) in Q1. Stocks of both drugmakers rose by 6 percent.In early April, FDA had granted accelerated approval to Merck’s Keytruda in combination with Seagen and Astellas Pharma’s Padcev as a first-line treatment for adults with locally advanced or metastatic urothelial carcinoma. Later in the month, Merck announced it is acquiring San Diego-based biotech Prometheus Biosciences for US$ 10.8 billion to strengthen its immunology pipeline. Prometheus’ stock skyrocketed 76 percent on the news.A combination of AstraZeneca's cancer drugs — Imfinzi and Lynparza — met its main goal in a late-stage trial for patients with advanced epithelial ovarian cancer. Additionally, Astra’s Ultomiris also received a positive recommendation from the European Medicines Agency (EMA) for adult patients with neuromyelitis optica spectrum disorder.Japanese drugmaker Astellas Pharma announced its biggest deal last month when it acquired New Jersey-based eye drug developer Iveric Bio for US$ 5.9 billion, taking its stock up 9 percent. The deal will give Astellas access to Iveric Bio’s ophthalmology treatments, including its lead drug candidate for geographic atrophy — Zimura. Iveric Bio’s stock gained 22 percent.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Disappointing Q1 sales drag AbbVie, BMS stocks downBoth AbbVie and Bristol Myers Squibb reported a drop in Q1 sales. AbbVie was hit due to weaker-than-expected performance of its blockbuster drugs Skyrizi and Rinvoq and dwindling sales of Humira (which experienced a sales drop of 25.2 percent in the face of biosimilar competition in the US). Its Q1 sales fell by 9.7 percent to US$ 12.25 billion, and its stock was down 6 percent. In positive news, FDA expanded the approval of AbbVie’s Qulipta as a preventive treatment for chronic migraine in adults. Rinvoq also received an add-on authorization in the EU as a treatment for moderate-to-severe active Crohn’s disease.BMS’ Q1 sales dropped 3 percent to US$ 11.3 billion, primarily due to an erosion in Revlimid’s sales in the face of competition from generic drugs. Revlimid’s revenues fell by 37 percent in Q1 compared to the same period last year. BMS’ stock experienced a 4 percent drop.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Our viewThe collapse of three US banks over the last three months has dealt a blow to the US economy. Globally, the business scenario hasn’t improved much, with inflation, high interest rates, ongoing Russia-Ukraine war, supply chain kinks and other uncertainties continuing to pose challenges.If the biotech indices are able to hold up in these difficult times, it is an indication of strength and resilience within the sector.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)

Impressions: 2161

https://www.pharmacompass.com/pipeline-prospector-blog/biotech-indices-inch-up-post-svb-bloodbath-covid-drugmakers-report-drop-in-q1-sales

#PharmaFlow by PHARMACOMPASS
11 May 2023

NEWS #PharmaBuzz

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https://www.suanfarma.com/apis-3/targeting-breast-cancer-with-precision-ribociclib-succinate-a-leading-cdk-4-6-inhibitor/

PRESS RELEASE
28 Mar 2025

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

PR NEWSWIRE
10 Dec 2024

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

GLOBENEWSWIRE
10 Dec 2024

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

GLOBENEWSWIRE
10 Dec 2024

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

GLOBENEWSWIRE
27 Nov 2024

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

GLOBENEWSWIRE
25 Nov 2024

Global Sales Information

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US Medicaid Prescriptions

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01

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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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03

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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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05

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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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08

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Company :

Ribociclib Succinate

Drug Cost (USD) : 0

Year : 2015

Prescribers :

Prescriptions : 0

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Regulatory FDF Prices

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Brand Name : Kisqali

Switzerland
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Brand Name : Kisqali

Switzerland
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Ribociclib

Dosage Form : Tabl

Dosage Strength : 200mg

Price Per Pack (Euro) : 924.1

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Brand Name : Kisqali

Switzerland
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China Battery Fair
Not Confirmed

Brand Name : Kisqali

Switzerland
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Not Confirmed

Ribociclib

Dosage Form : Tabl

Dosage Strength : 200mg

Price Per Pack (Euro) : 1584.53

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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03

Brand Name : Kisqali

Switzerland
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China Battery Fair
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Brand Name : Kisqali

Switzerland
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Ribociclib

Dosage Form : Tabl

Dosage Strength : 200mg

Price Per Pack (Euro) : 2197.23

Published in :

Country : Switzerland

RX/OTC/DISCN : Class A

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Annual Reports

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Brand Name : Kisqali

Ribociclib

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Brand Name : Kisqali

Switzerland
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Ribociclib

Main Therapeutic Indication : Oncology

Currency : USD

2020 Revenue in Millions : 687

2019 Revenue in Millions : 480

Growth (%) : 43

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Brand Name : Kisqali

Ribociclib

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Brand Name : Kisqali

Switzerland
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Ribociclib

Main Therapeutic Indication : Oncology

Currency : USD

2021 Revenue in Millions : 937

2020 Revenue in Millions : 687

Growth (%) : 36

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Brand Name : Kisqali

Ribociclib

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Brand Name : Kisqali

Switzerland
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Ribociclib

Main Therapeutic Indication : Oncology

Currency : USD

2022 Revenue in Millions : 1,231

2021 Revenue in Millions : 937

Growth (%) : 31

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Brand Name : Kisqali

Ribociclib

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Brand Name : Kisqali

Switzerland
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Ribociclib

Main Therapeutic Indication : Oncology

Currency : USD

2023 Revenue in Millions : 2,080

2022 Revenue in Millions : 1,231

Growth (%) : 69

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Brand Name : Kisqali

Ribociclib Succinate

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Brand Name : Kisqali

Switzerland
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Ribociclib Succinate

Main Therapeutic Indication : Oncology

Currency : USD

2017 Revenue in Millions : 76

2016 Revenue in Millions : 0

Growth (%) : New Launch

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Brand Name : Kisqali

Ribociclib Succinate

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Brand Name : Kisqali

Switzerland
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Ribociclib Succinate

Main Therapeutic Indication : Oncology

Currency : USD

2018 Revenue in Millions : 235

2017 Revenue in Millions : 76

Growth (%) : 209%

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Brand Name : Kisqali

Ribociclib

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Brand Name : Kisqali

Switzerland
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Ribociclib

Main Therapeutic Indication : Oncology

Currency : USD

2019 Revenue in Millions : 480

2018 Revenue in Millions : 235

Growth (%) : 104

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Ribociclib manufacturers, exporters & distributors 1

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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.

API | Excipient name

Ribociclib

Synonyms

Lee011 succinate, 1374639-75-4, Lee-011 succinate, Lee011-bba, Ribociclib succinate [usan], Kisqali

Cas Number

1374639-75-4

Unique Ingredient Identifier (UNII)

BG7HLX2919

Ribociclib Manufacturers

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.

Ribociclib Suppliers

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.

Ribociclib USDMF

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.

Ribociclib KDMF

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.

Ribociclib WC

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.

Ribociclib NDC

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).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Ribociclib API and other APIs are published in this directory by the FDA.

Unfinished drugs

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.

Compounded drug products

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 GMP

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.

Ribociclib CoA

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).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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