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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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CEP/COS

CEP/COS Certifications

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JDMF

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KDMF

KDMF

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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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01

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

02

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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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Aarti Industries Company Banner

03

Chunghwa Chemical Synthesis & Biot...

Taiwan

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

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euroPLX 86 Munich
Not Confirmed
  • 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 arrow-down CEP/COS JDMF EU-WC NDC arrow-down KDMF VMF Others AUDIT
CCSB Company Banner

04

Teva Pharmaceutical Industries

Israel

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

euroPLX 86 Munich
Not Confirmed
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Teva Pharmaceutical Industries

Israel

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

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euroPLX 86 Munich
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Intas Pharmaceuticals

India

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

euroPLX 86 Munich
Not Confirmed
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Intas Pharmaceuticals

India

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

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euroPLX 86 Munich
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MSN Laboratories

India

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

euroPLX 86 Munich
Not Confirmed
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MSN Laboratories

India

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

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euroPLX 86 Munich
Not Confirmed
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Fresenius Kabi Oncology Limited

India

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

euroPLX 86 Munich
Not Confirmed
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Fresenius Kabi Oncology Limited

India

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

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euroPLX 86 Munich
Not Confirmed
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Cdymax

India

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

euroPLX 86 Munich
Not Confirmed
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09

Alembic Pharmaceuticals Limited

India

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

euroPLX 86 Munich
Not Confirmed
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Alembic Pharmaceuticals Limited

India

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

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euroPLX 86 Munich
Not Confirmed
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Teva API

Israel

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

euroPLX 86 Munich
Not Confirmed
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USDMF

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Pharmtech & Ingredients
Not Confirmed
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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

CCSB Company Banner

02

Pharmtech & Ingredients
Not Confirmed

02

Pharmtech & Ingredients
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 35027

Submission : 2020-09-10

Status : Inactive

Type : II

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Pharmtech & Ingredients
Not Confirmed

03

Pharmtech & Ingredients
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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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Pharmtech & Ingredients
Not Confirmed

04

Pharmtech & Ingredients
Not Confirmed

GDUFA

DMF Review : Complete

Rev. Date : 2020-11-03

Pay. Date : 2020-09-25

DMF Number : 35098

Submission : 2020-09-01

Status : Active

Type : II

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Pharmtech & Ingredients
Not Confirmed

05

Pharmtech & Ingredients
Not Confirmed

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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EU WC

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01

Pharmtech & Ingredients
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Ribociclib Succinate IH

Date of Issue : 2022-06-17

Valid Till : 2025-07-02

Written Confirmation Number : WC-0082

Address of the Firm : API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, G...

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02

Pharmtech & Ingredients
Not Confirmed
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Ribociclib Succinate IH

Date of Issue : 2021-10-05

Valid Till : 2022-07-02

Written Confirmation Number : WC-0082A11

Address of the Firm : API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, G...

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Pharmtech & Ingredients
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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 : MIs. MSN Laboratories Private Limited, Unit-II, sv. No, 50, Kardanur (Village), ...

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NDC API

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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

NDC Package Code : 52076-6261

Start Marketing Date : 2018-10-03

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (5kg/5kg)

Marketing Category : BULK INGREDIENT

CCSB Company Banner

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Pharmtech & Ingredients
Not Confirmed
  • 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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Digital Content Digital Content

RIBOCICLIB SUCCINATE

NDC Package Code : 52076-6203

Start Marketing Date : 2017-09-26

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (5kg/5kg)

Marketing Category : BULK INGREDIENT

CCSB Company Banner

03

Pharmtech & Ingredients
Not Confirmed
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RIBOCICLIB SUCCINATE

NDC Package Code : 54893-0101

Start Marketing Date : 2020-08-29

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Pharmtech & Ingredients
Not Confirmed
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RIBOCICLIB SUCCINATE

NDC Package Code : 63592-1600

Start Marketing Date : 2020-09-23

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (100kg/100kg)

Marketing Category : BULK INGREDIENT

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Pharmtech & Ingredients
Not Confirmed
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RIBOCICLIB SUCCINATE

NDC Package Code : 65344-0036

Start Marketing Date : 2021-09-28

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Valary Lab Private Limited

Country
Pharmtech & Ingredients
Not Confirmed
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Valary Lab Private Limited

Country
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Pharmtech & Ingredients
Not Confirmed

RIBOCICLIB SUCCINATE

NDC Package Code : 81955-0003

Start Marketing Date : 2017-03-13

End Marketing Date : 2024-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

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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Digital Content Digital Content

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.
Egis Pharmaceuticals

02

  • fda
  • EDQM
  • WHO-GMP

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

Flag India
Digital Content Digital Content

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
Aarti Industries Company Banner

03

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  • fda
  • EDQM
  • WHO-GMP

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

Flag Taiwan
Digital Content Digital Content

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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04

Arevipharma

Germany
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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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05

Cdymax

India
BioFlorida Conference
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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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BioFlorida Conference
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Ribociclib

About the Company : Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was fou...

Changzhou Pharmaceutical Factory (CPF) is a subsidiary company of Shanghai Pharma Holdings Co., Ltd., It is headquartered in Changzhou, Jiangsu Province, China. The company was founded in 1949 by (Tan Ruiting) with a registered capital of 108 million yuan and the company was restructured as a Changzhou pharmaceutical Factory under the aegis of the Shanghai Pharma Group. The company mainly involves leading pharmaceutical manufacturers a wide range of key Intermediates, Active pharmaceutical ingredients, and Finished Formulations that meet with global standards.
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07

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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08

Hetero Drugs

India
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Hetero Drugs

India
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Ribociclib

About the Company : Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & F...

Hetero is a research based global pharmaceutical company focused on development, manufacturing and marketing of Active Pharmaceutical Ingredients (APIs), Intermediate Chemicals & Finished Dosages. Ever since its establishment in 1993, Hetero showed a tradition of excellence and deep sense of commitment in developing cost effective processes to offer wide range of affordable drugs. Hetero is building on the strengths of vertical integration in discovery research, process chemistry, API manufacturing, formulation development and commercialization.
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Natco Pharma

India
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Natco Pharma

India
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Ribociclib

About the Company : NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 e...

NATCO PHARMA LIMITED was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. With a modest beginning of operations as a single unit with 20 employees, NATCO today has five manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in New Drug Development, etc.NATCO family currently consists of more than 2500 employees, we are consistently ranked among fastest growing pharmaceutical companies in India. NATCO is well recognized for its innovation in Pharmaceutical R&D.
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Teva API

Israel
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Teva API

Israel
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Ribociclib

About the Company : Teva API is a standalone business unit within Teva Pharmaceutical Industries, the world’s largest generic drug manufacturer. Employing over 4,000 professionals at 15 internationa...

Teva API is a standalone business unit within Teva Pharmaceutical Industries, the world’s largest generic drug manufacturer. Employing over 4,000 professionals at 15 international plant sites and 6 R&D centers, Teva API is a leading international supplier of active pharmaceutical ingredients (APIs) with the industry’s broadest portfolio of over 350 products. Its leadership in cutting-edge development, large-scale production capacity and global support make it an ideal API partner of choice. Over its more than 85 years of existence, Teva API has acquired and established top-rated manufacturing and development facilities around the world.
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FDA Orange Book

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01

BioFlorida Conference
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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
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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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Europe

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BioFlorida Conference
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Ribociclibum

Brand Name : Kisqali

Dosage Form : Tabl

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

BioFlorida Conference
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Ribociclibum

Brand Name : Kisqali

Dosage Form : Tabl

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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03

BioFlorida Conference
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BioFlorida Conference
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Ribociclibum

Brand Name : Kisqali

Dosage Form : Tabl

Dosage Strength : 200mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Australia

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Novartis Pharmaceuticals Australia Pty L...

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ribociclib

Brand Name : Kisqali

Dosage Form :

Dosage Strength :

Packaging : 21

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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02

Novartis Pharmaceuticals Australia Pty L...

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BioFlorida Conference
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Novartis Pharmaceuticals Australia Pty L...

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ribociclib

Brand Name : Kisqali

Dosage Form :

Dosage Strength :

Packaging : 63

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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03

Novartis Pharmaceuticals Australia Pty L...

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BioFlorida Conference
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Novartis Pharmaceuticals Australia Pty L...

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ribociclib

Brand Name : Kisqali

Dosage Form :

Dosage Strength :

Packaging : 42

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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South Africa

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Novartis South Africa (Pty) Ltd

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Novartis South Africa (Pty) Ltd

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Ribociclib

Brand Name : KRYXANA 200MG

Dosage Form : FCT

Dosage Strength : 200mg

Packaging : 21X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Listed Dossiers

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  • fda
  • EDQM
  • WHO-GMP

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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Digital Content Digital Content

Regulatory Info :

Registration Country : Hungary

Ribociclib

Brand Name :

Dosage Form : Tablet

Dosage Strength : 200MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Hungary

Egis Pharmaceuticals

01

  • fda
  • EDQM
  • WHO-GMP

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

Flag Hungary
Digital Content Digital Content

Packaging :

Regulatory Info :

Ribociclib

Dosage : Tablet

Dosage Strength : 200MG

Brand Name :

Approval Date :

Application Number :

Registration Country : Hungary

Egis Pharmaceuticals
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Patents & EXCLUSIVITIES

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US Patents

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01

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Pharmtech & Ingredients
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NOVARTIS

Switzerland
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Pharmtech & Ingredients
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RIBOCICLIB SUCCINATE

US Patent Number : 9868739

Drug Substance Claim :

Drug Product Claim :

Application Number : 209092

Patent Use Code : U-3975

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-11-09

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02

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Pharmtech & Ingredients
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NOVARTIS

Switzerland
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Pharmtech & Ingredients
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LETROZOLE; RIBOCICLIB SUCCINATE

US Patent Number : 8685980

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 209935

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2030-05-25

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03

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Pharmtech & Ingredients
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NOVARTIS

Switzerland
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Pharmtech & Ingredients
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LETROZOLE; RIBOCICLIB SUCCINATE

US Patent Number : 8962630

Drug Substance Claim :

Drug Product Claim :

Application Number : 209935

Patent Use Code : U-2505

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-12-09

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04

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Pharmtech & Ingredients
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NOVARTIS

Switzerland
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Pharmtech & Ingredients
Not Confirmed

LETROZOLE; RIBOCICLIB SUCCINATE

US Patent Number : 8415355

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 209935

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-03-13

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05

arrow
Pharmtech & Ingredients
Not Confirmed

NOVARTIS

Switzerland
arrow
Pharmtech & Ingredients
Not Confirmed

RIBOCICLIB SUCCINATE

US Patent Number : 9416136

Drug Substance Claim :

Drug Product Claim :

Application Number : 209092

Patent Use Code : U-3975

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-08-20

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06

arrow
Pharmtech & Ingredients
Not Confirmed

NOVARTIS

Switzerland
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Pharmtech & Ingredients
Not Confirmed

LETROZOLE; RIBOCICLIB SUCCINATE

US Patent Number : 8962630

Drug Substance Claim :

Drug Product Claim :

Application Number : 209935

Patent Use Code : U-3264

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-12-09

blank

07

arrow
Pharmtech & Ingredients
Not Confirmed

NOVARTIS

Switzerland
arrow
Pharmtech & Ingredients
Not Confirmed

RIBOCICLIB SUCCINATE

US Patent Number : 9868739

Drug Substance Claim :

Drug Product Claim :

Application Number : 209092

Patent Use Code : U-1981

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2031-11-09

blank

08

arrow
Pharmtech & Ingredients
Not Confirmed

NOVARTIS

Switzerland
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Pharmtech & Ingredients
Not Confirmed

RIBOCICLIB SUCCINATE

US Patent Number : 8324225

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 209092

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-06-17

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09

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Pharmtech & Ingredients
Not Confirmed

NOVARTIS

Switzerland
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Pharmtech & Ingredients
Not Confirmed

LETROZOLE; RIBOCICLIB SUCCINATE

US Patent Number : 12064434

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 209935

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-04-14

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10

arrow
Pharmtech & Ingredients
Not Confirmed

NOVARTIS

Switzerland
arrow
Pharmtech & Ingredients
Not Confirmed

LETROZOLE; RIBOCICLIB SUCCINATE

US Patent Number : 9416136

Drug Substance Claim :

Drug Product Claim :

Application Number : 209935

Patent Use Code : U-2505

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-08-20

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US Exclusivities

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01

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NOVARTIS

Switzerland
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Pharmtech & Ingredients
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RIBOCICLIB SUCCINATE

Exclusivity Code : NPP

Exclusivity Expiration Date : 2024-12-10

Application Number : 209092

Product Number : 1

Exclusivity Details :

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02

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Pharmtech & Ingredients
Not Confirmed

NOVARTIS

Switzerland
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Pharmtech & Ingredients
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RIBOCICLIB SUCCINATE

Exclusivity Code : I-950

Exclusivity Expiration Date : 2027-09-17

Application Number : 209092

Product Number : 1

Exclusivity Details :

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03

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Pharmtech & Ingredients
Not Confirmed

NOVARTIS

Switzerland
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Pharmtech & Ingredients
Not Confirmed

LETROZOLE; RIBOCICLIB SUCCINATE

Exclusivity Code : NPP

Exclusivity Expiration Date : 2024-12-10

Application Number : 209935

Product Number : 1

Exclusivity Details :

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04

arrow
Pharmtech & Ingredients
Not Confirmed

NOVARTIS

Switzerland
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Pharmtech & Ingredients
Not Confirmed

LETROZOLE; RIBOCICLIB SUCCINATE

Exclusivity Code : I-951

Exclusivity Expiration Date : 2027-09-17

Application Number : 209935

Product Number : 1

Exclusivity Details :

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