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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

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Suanfarma

Spain

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ChemExpress

China

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Lee Fine Chem

India

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Virtual BoothLee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.

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Aarti Pharmalabs

India

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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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Chunghwa Chemical Synthesis & Biot...

Taiwan

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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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TAPI Technology & API Services

Israel

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Chunghwa Chemical Synthesis & Biot...

Taiwan

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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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Teva Pharmaceutical Industries

Israel

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Teva Pharmaceutical Industries

Israel

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Fresenius Kabi Oncology Limited

India

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Fresenius Kabi Oncology Limited

India

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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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Boulder Peptide
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Boulder Peptide
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41518

Submission : 2025-03-31

Status : Active

Type : II

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Boulder Peptide
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Boulder Peptide
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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35027

Submission : 2020-09-10

Status : Inactive

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Boulder Peptide
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Boulder Peptide
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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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Boulder Peptide
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Boulder Peptide
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DMF Review : Complete

Rev. Date : 2020-11-03

Pay. Date : 2020-09-25

DMF Number : 35098

Submission : 2020-09-01

Status : Active

Type : II

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Boulder Peptide
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Tapi Nl Bv

Israel

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Tapi Nl Bv

Israel
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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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Valary Lab Private Ltd

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 41424

Submission : 2025-03-14

Status : Active

Type : II

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EU WC

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Biotech Week Boston
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Ribociclib Succinate IH

Date of Issue : 2022-06-17

Valid Till : 2025-02-07

Written Confirmation Number : WC-0082

Address of the Firm : Karakhadi Plot No. 842-843, At - Karakhdi, Tal. - Padra, Dist - Vadodara 391 450...

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Ribociclib succinate IH

Date of Issue : 2022-09-02

Valid Till : 2025-05-05

Written Confirmation Number : WC-0349

Address of the Firm : Unit-II, Sy. No. 50, Kardanur (Village), Patancheru (Mandai), Sangareddy Distric...

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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 is a B2B life sciences company dedicated to health and advancement. To achieve this, the company focuses on developing, manufacturing, and distributing high-quality ingre...

Suanfarma is a B2B life sciences company dedicated to health and advancement. To achieve this, the company focuses on developing, manufacturing, and distributing high-quality ingredients for the pharmaceutical industry in an innovative and sustainable way. Backed by a robust global network of 10 strategically located offices, Suanfarma serves more than 400 active customers across 70+ countries. The company works closely with customers in the development of their final formulations, adding value throughout the entire drug development process by delivering customized solutions.
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ChemExpress

China
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Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

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Ribociclib

About the Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and new modalities such as...

Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and new modalities such as ADCs/XDCs, peptides and PROTACs. Our comprehensive platform is engaged in the research and development, manufacturing and supply of regulatory starting materials, novel building blocks, intermediates, reference compounds, APIs and drug products (solid & semi-solid, biologics liquid & lyophilized). We support our clients' projects from early drug discovery, process development to commercialization.
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Virtual BoothLee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.

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Ribociclib

About the Company : Lee Fine Chem Private Limited specializes in Advanced Intermediates, Active Pharmaceutical Ingredients (APIs), and Finished Dosage Forms. With a strong focus on quality and innovat...

Lee Fine Chem Private Limited specializes in Advanced Intermediates, Active Pharmaceutical Ingredients (APIs), and Finished Dosage Forms. With a strong focus on quality and innovation, we deliver high-performance pharmaceutical solutions to global markets. Our state-of-the-art facilities and expert team ensure compliance, consistency, and excellence at every stage of development and production. Trust Lee Fine Chem for reliable, efficient, and cutting-edge pharmaceutical products.
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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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06

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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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07

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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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08

Cell Therapy
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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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Cell Therapy
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Ribociclib

About the Company : Sichuan Taienkang Pharmaceutical Co., Ltd., established in 2020, is a subsidiary of Guangdong Taienkang Pharmaceutical Co., Ltd. The company specializes in the R&D, production, and...

Sichuan Taienkang Pharmaceutical Co., Ltd., established in 2020, is a subsidiary of Guangdong Taienkang Pharmaceutical Co., Ltd. The company specializes in the R&D, production, and sales of generic APIs and intermediates, focusing on high-value APIs such as Dapoxetine Hydrochloride, Tadalafil, and others to meet diverse market needs. Located in the Yuechi Economic Development Zone, Sichuan Province, the manufacturing site spans 100 acres within a provincial-level chemical industry park. Phase one includes 4 independent production lines and a Class D GMP workshop, equipped with 500L to 5000L multifunctional reactors.
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Viatris

U.S.A
Cell Therapy
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Viatris

U.S.A
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Ribociclib Succinate

About the Company : In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (N...

In November 2020, Viatris was formed through the combination of Mylan and Upjohn, with a mission of empowering people worldwide to live healthier at every stage of life. Viatris (NASDAQ: VTRS) is a global healthcare company empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020.
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API Reference Price

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Export","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1737570600,"product":"RIBOCICLIB SUCCINATE","address":"8-3-166\/7\/1, ERRAGADDA,,ERRAGADDA","city":"HYDERABAD,TELANGANA","supplier":"VALARY LAB PRIVATE LTD","supplierCountry":"INDIA","foreign_port":"DUBAI","customer":"ORBIT SHIPPING SERVICES LLC","customerCountry":"UNITED ARAB EMIRATES","quantity":"0.15","actualQuantity":"0.15","unit":"KGS","unitRateFc":"20000","totalValueFC":"3011.2","currency":"EURO","unitRateINR":1731000,"date":"23-Jan-2025","totalValueINR":"259650","totalValueInUsd":"3011.2","indian_port":"Hyderabad Air","hs_no":"29349990","bill_no":"7533012","productDescription":"API","marketType":"","country":"UNITED ARAB EMIRATES","selfForZScoreResived":"Pharma Grade","supplierPort":"Hyderabad Air","supplierAddress":"8-3-166\/7\/1, ERRAGADDA,,ERRAGADDA, HYDERABAD,TELANGANA","customerAddress":""},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q1","strtotime":1678732200,"product":"RIBOCICLIB SUCCINATE (LEE)-51000171 -H10507-03 (2X1000 MG) FOC","address":"KALWE MIDC PLOT NO.8-A\/2 8\/B,TTC I NDUSTRIAL AREA KALWE BLOCK","city":"VILLAGE DIGHE NAVI MUMBAI THANE,MAH","supplier":"LEK PHARMACEUTICALS DD","supplierCountry":"SLOVENIA","foreign_port":"NA","customer":"SANDOZ PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"2","unit":"GMS","unitRateFc":"265.8","totalValueFC":"539.8","currency":"USD","unitRateINR":"22198.1","date":"14-Mar-2023","totalValueINR":"44396.12","totalValueInUsd":"539.8","indian_port":"BOMBAY AIR","hs_no":"29335990","bill_no":"5034164","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"KALWE MIDC PLOT NO.8-A\/2 8\/B,TTC I NDUSTRIAL AREA KALWE BLOCK"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q3","strtotime":1689532200,"product":"RIBOCICLIB SUCCINATE\/DS 04.(FREE OF COST.THIS MATERIAL IS SENT FOR ANALYTICAL PURPOSE ONLY AND HAS NO COMMERCIAL VALUE.)","address":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD","city":"HYDERABAD,A.P.","supplier":"NOVARTIS PHARMA AG BASEL","supplierCountry":"CHINA","foreign_port":"CHANGI","customer":"DIVIS LABORATORIES LTD","customerCountry":"INDIA","quantity":"0.72","actualQuantity":"715","unit":"GMS","unitRateFc":"30.7","totalValueFC":"22216.2","currency":"USD","unitRateINR":"2553.8","date":"17-Jul-2023","totalValueINR":"1825942","totalValueInUsd":"22216.2","indian_port":"Vizag-DLL SEZ","hs_no":"29335990","bill_no":"1000606","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"CHANGI","supplierAddress":"N\/A","customerAddress":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"RIBOCICLIB SUCCINATE (LEE001)","address":"SANDOZ HOUSE,8TH FLOOR,","city":"MUMBAI,MAHARASHTRA","supplier":"NOVARTIS PHARMACEUTICALS MANUFACTURING LLC","supplierCountry":"SLOVENIA","foreign_port":"LJUBLJANA - BRNIK","customer":"NOVARTIS HEALTHCARE PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"1","unit":"GMS","unitRateFc":"274","totalValueFC":"332.5","currency":"EURO","unitRateINR":"27792.4","date":"30-Jul-2024","totalValueINR":"27792.39","totalValueInUsd":"332.5","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"4778555","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LJUBLJANA - BRNIK","supplierAddress":"VEROVSKOVA ULICA 571000 LJUBLJANASLOVENIA SI","customerAddress":"SANDOZ HOUSE,8TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2024","qtr":"Q3","strtotime":1722277800,"product":"RIBOCICLIB SUCCINATE (LEE001)","address":"SANDOZ HOUSE,8TH FLOOR,","city":"MUMBAI,MAHARASHTRA","supplier":"NOVARTIS PHARMACEUTICALS MANUFACTURING LLC","supplierCountry":"SLOVENIA","foreign_port":"LJUBLJANA - BRNIK","customer":"NOVARTIS HEALTHCARE PRIVATE LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"5","unit":"GMS","unitRateFc":"274","totalValueFC":"1662.4","currency":"EURO","unitRateINR":"27792.8","date":"30-Jul-2024","totalValueINR":"138963.79","totalValueInUsd":"1662.4","indian_port":"Hyderabad Air","hs_no":"29335990","bill_no":"4778555","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"LJUBLJANA - BRNIK","supplierAddress":"VEROVSKOVA ULICA 571000 LJUBLJANASLOVENIA SI","customerAddress":"SANDOZ HOUSE,8TH FLOOR,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q1","strtotime":1741717800,"product":"RIBOCICLIB SUCCINATE (LEE001)","address":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD","city":"HYDERABAD,A.P.","supplier":"NOVARTIS PHARMACEUTICAL MANUFACTURING LLC","supplierCountry":"SLOVENIA","foreign_port":"HYDERABAD","customer":"DIVIS LABORATORIES LTD","customerCountry":"INDIA","quantity":"0.01","actualQuantity":"6","unit":"GMS","unitRateFc":"302.9","totalValueFC":"1842.4","currency":"USD","unitRateINR":"26597.1","date":"12-Mar-2025","totalValueINR":"159582.41","totalValueInUsd":"1842.4","indian_port":"Vizag-DLL SEZ","hs_no":"29333929","bill_no":"8837487","productDescription":"API","marketType":"REGULATED MARKET","country":"SLOVENIA","selfForZScoreResived":"Pharma Grade","supplierPort":"HYDERABAD","supplierAddress":"VEROVSKOVA ULICA 57 1000 LJUBLIJANA SDNF Slovenia","customerAddress":"7.1.77\/E\/1\/303, DHARAM KARAM ROAD"}]
18-Feb-2022
12-Mar-2025
KGS
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Drugs in Development

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Details:

Palazestrant is a Other Small Molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Breast Neoplasms.


Lead Product(s): Palazestrant,Letrozole,Ribociclib

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 25, 2025

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01

Biotech Week Boston
Not Confirmed
Biotech Week Boston
Not Confirmed

Details : Palazestrant is a Other Small Molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Breast Neoplasms.

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 25, 2025

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Details:

Inavolisib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Breast Neoplasms.


Lead Product(s): Inavolisib,Ribociclib,Letrozole

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 08, 2025

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02

F. Hoffmann-La Roche

Switzerland
arrow
Biotech Week Boston
Not Confirmed

F. Hoffmann-La Roche

Switzerland
arrow
Biotech Week Boston
Not Confirmed

Details : Inavolisib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Breast Neoplasms.

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

July 08, 2025

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  • Development Update

Details:

FWD1802 is a drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Breast Neoplasms.


Lead Product(s): FWD1802,Palbociclib,Ribociclib,Abemaciclib,Everolimus

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Undisclosed

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable June 03, 2025

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03

Forward Pharma

Country
arrow
Biotech Week Boston
Not Confirmed

Forward Pharma

Country
arrow
Biotech Week Boston
Not Confirmed

Details : FWD1802 is a drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Breast Neoplasms.

Product Name : Undisclosed

Product Type : Undisclosed

Upfront Cash : Inapplicable

June 03, 2025

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  • Development Update

Details:

Undisclosed


Lead Product(s): Ribociclib,Letrozole,Anastrozole,Goserelin Acetate

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Novartis Pharmaceuticals Corporation | Breast Cancer Research Foundation

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 01, 2025

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04

Yale University

Country
arrow
Biotech Week Boston
Not Confirmed

Yale University

Country
arrow
Biotech Week Boston
Not Confirmed

Lead Product(s) : Ribociclib,Letrozole,Anastrozole,Goserelin Acetate

Therapeutic Area : Oncology

Highest Development Status : Phase II

Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation | Breast Cancer Research Foundation

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Undisclosed

Product Name : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 01, 2025

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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.


Lead Product(s): Camizestrant,Palbociclib,Ribociclib

Therapeutic Area: Oncology Brand Name: Undisclosed

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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05

AstraZeneca

United Kingdom
arrow
Biotech Week Boston
Not Confirmed

AstraZeneca

United Kingdom
arrow
Biotech Week Boston
Not Confirmed

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 : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 26, 2025

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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,Inapplicable

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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06

Biotech Week Boston
Not Confirmed
Biotech Week Boston
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

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,Inapplicable

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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07

Biotech Week Boston
Not Confirmed
Biotech Week Boston
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

November 27, 2024

blank

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,Inapplicable

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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08

Biotech Week Boston
Not Confirmed
Biotech Week Boston
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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09

Biotech Week Boston
Not Confirmed
Biotech Week Boston
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: Undisclosed

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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10

Biotech Week Boston
Not Confirmed
Biotech Week Boston
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 : Undisclosed

Product Type : Other Small Molecule

Upfront Cash : Undisclosed

February 12, 2024

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ABOUT THIS PAGE

Looking for 1374639-75-4 / Ribociclib API manufacturers, exporters & distributors?

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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