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1. Kisqali
2. Lee011
3. Ribociclib
1. Lee011 Succinate
2. 1374639-75-4
3. Lee-011 Succinate
4. Lee011-bba
5. Ribociclib Succinate [usan]
6. Kisqali
7. Lee-011-bba
8. Bg7hlx2919
9. 7-cyclopentyl-n,n-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide Succinate
10. Butanedioic Acid;7-cyclopentyl-n,n-dimethyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrrolo[2,3-d]pyrimidine-6-carboxamide
11. Ribociclib Succinate (usan)
12. Butanedioic Acid, Compd. With 7-cyclopentyl-n,n-dimethyl-2-((5-(1-piperazinyl)-2-pyridinyl)amino)-7h-pyrrolo(2,3-d)pyrimidine-6-carboxamide (1:1)
13. Butanedioic Acid, Compd. With 7-cyclopentyl-n,n-dimethyl-2-[[5-(1-piperazinyl)-2-pyridinyl]amino]-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide (1:1)
14. Unii-bg7hlx2919
15. Kisqali (tn)
16. Lee011 (succinate)
17. Birociclib [who-dd]
18. Schembl2684999
19. Chembl3707266
20. Ribociclib Succinate [mi]
21. Dtxsid301027923
22. Amy25508
23. Bcp12715
24. Ex-a1586
25. Zec63975
26. Lee011 Succinatelee011 Succinate
27. Hy-15777b
28. S5188
29. Ribociclib Succinate [who-dd]
30. Sb18482
31. Ac-30654
32. As-75241
33. Ribociclib Succinate [orange Book]
34. D10979
35. Lee-011 Succinate Salt, Ribociclib Succinate Salt
36. J-007026
37. Q27274660
38. Kisqali Femara Co-pack Component Ribociclib Succinate
39. Ribociclib Succinate Component Of Kisqali Femara Co-pack
40. 7-cyclopentyl-n,n-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7h-pyrrolo[2,3-d]pyrimidine-6-carboxamide; Butanedioic Acid
Molecular Weight | 552.6 g/mol |
---|---|
Molecular Formula | C27H36N8O5 |
Hydrogen Bond Donor Count | 4 |
Hydrogen Bond Acceptor Count | 11 |
Rotatable Bond Count | 8 |
Exact Mass | 552.28086628 g/mol |
Monoisotopic Mass | 552.28086628 g/mol |
Topological Polar Surface Area | 166 Ų |
Heavy Atom Count | 40 |
Formal Charge | 0 |
Complexity | 728 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 2 |
1 of 2 | |
---|---|
Drug Name | KISQALI |
Active Ingredient | RIBOCICLIB SUCCINATE |
Company | NOVARTIS PHARMS CORP (Application Number: N209092. Patents: 8324225, 8415355, 8685980, 8962630, 9193732, 9416136, 9868739) |
2 of 2 | |
---|---|
Drug Name | KISQALI FEMARA CO-PACK (COPACKAGED) |
Active Ingredient | LETROZOLE; RIBOCICLIB SUCCINATE |
Company | NOVARTIS PHARMS CORP (Application Number: N209935. Patents: 8324225, 8415355, 8685980, 8962630, 9193732, 9416136, 9868739) |
Kisqali is indicated for the treatment of women with hormone receptor (HR)positive, human epidermal growth factor receptor 2 (HER2)negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
In pre or perimenopausal women, the endocrine therapy should be combined with a luteinising hormonereleasing hormone (LHRH) agonist.
L01XE
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36174
Submission : 2021-11-30
Status : Active
Type : II
NDC Package Code : 52076-6261
Start Marketing Date : 2018-10-03
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
NDC Package Code : 52076-6203
Start Marketing Date : 2017-09-26
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (5kg/5kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-01-22
Pay. Date : 2020-10-09
DMF Number : 35288
Submission : 2020-11-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35027
Submission : 2020-09-10
Status : Inactive
Type : II
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36174
Submission : 2021-11-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41518
Submission : 2025-03-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35027
Submission : 2020-09-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-11-18
Pay. Date : 2021-09-24
DMF Number : 36335
Submission : 2021-09-30
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2020-11-03
Pay. Date : 2020-09-25
DMF Number : 35098
Submission : 2020-09-01
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41179
Submission : 2025-03-28
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2021-01-22
Pay. Date : 2020-10-09
DMF Number : 35288
Submission : 2020-11-26
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41424
Submission : 2025-03-14
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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...
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...
Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.
About the Company : Egis is a member of the Servier Group. Egis’ products are manufactured at 3 production sites in Hungary, which are certified by EMA,FDA, ANVISA, PMDA ,KFDA. Egis sells its produc...
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ChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.
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...
Lee Fine Chem: Advancing Innovation and Quality in Intermediates, APIs, and Dosage Forms for Superior Pharmaceutical Solutions.
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...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
About the Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, corticosteroids, cyto...
Chunghwa provides cost-effective APIs & advanced intermediates with complete DMF or COS, ensuring quality & reliable production.
About the Company : Chunghwa Chemical Synthesis & Biotech Co. Ltd. (CCSB) offers global customers cost-effective APIs with speed, supported by our well-trained staff. As the first company in Southeast...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : 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...
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...
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...
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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
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Sponsor: Novartis Pharmaceuticals Corporation
Deal Size: Inapplicable Upfront Cash: Inapplicable
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Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation
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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
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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
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Deal Type: Inapplicable June 03, 2025
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Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
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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
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Upfront Cash : Inapplicable
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Lead Product(s): Ribociclib,Letrozole,Anastrozole,Goserelin Acetate
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Sponsor: Novartis Pharmaceuticals Corporation | Breast Cancer Research Foundation
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Deal Type: Inapplicable May 01, 2025
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Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Novartis Pharmaceuticals Corporation | Breast Cancer Research Foundation
Deal Size : Inapplicable
Deal Type : Inapplicable
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Upfront Cash : Inapplicable
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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.
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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 : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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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
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Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
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Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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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
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
Lead Product(s) : Ribociclib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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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
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
Lead Product(s) : Ribociclib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Novartis Gets Positive CHMP Opinion for Kisqali® in Breast Cancer
Details : Kisqali (ribociclib) is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.
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Product Type : Other Small Molecule
Upfront Cash : Inapplicable
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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.
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Deal Size: Inapplicable Upfront Cash: Inapplicable
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Product Name : Kisqali
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 17, 2024
Details:
The net proceeds will be used to fund the clinical development of company's lead product OP-1250 (palazestrant), which is being evaluated for the treatment of ER+/HER2-metastatic breast cancer.
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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
Lead Product(s) : Palazestrant,Ribociclib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Adage Capital Partners
Deal Size : $250.0 million
Deal Type : Private Placement
Olema & Novartis Collaborate on Breast Cancer Trials, Raise $250M Equity Placement
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Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
February 12, 2024
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PharmaCompass offers a list of Ribociclib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ribociclib manufacturer or Ribociclib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ribociclib manufacturer or Ribociclib supplier.
PharmaCompass also assists you with knowing the Ribociclib API Price utilized in the formulation of products. Ribociclib API Price is not always fixed or binding as the Ribociclib Price is obtained through a variety of data sources. The Ribociclib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ribociclib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ribociclib, including repackagers and relabelers. The FDA regulates Ribociclib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ribociclib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ribociclib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ribociclib supplier is an individual or a company that provides Ribociclib active pharmaceutical ingredient (API) or Ribociclib finished formulations upon request. The Ribociclib suppliers may include Ribociclib API manufacturers, exporters, distributors and traders.
click here to find a list of Ribociclib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ribociclib DMF (Drug Master File) is a document detailing the whole manufacturing process of Ribociclib active pharmaceutical ingredient (API) in detail. Different forms of Ribociclib DMFs exist exist since differing nations have different regulations, such as Ribociclib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ribociclib DMF submitted to regulatory agencies in the US is known as a USDMF. Ribociclib USDMF includes data on Ribociclib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ribociclib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ribociclib suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ribociclib Drug Master File in Korea (Ribociclib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ribociclib. The MFDS reviews the Ribociclib KDMF as part of the drug registration process and uses the information provided in the Ribociclib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ribociclib KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ribociclib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ribociclib suppliers with KDMF on PharmaCompass.
A Ribociclib written confirmation (Ribociclib WC) is an official document issued by a regulatory agency to a Ribociclib manufacturer, verifying that the manufacturing facility of a Ribociclib active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ribociclib APIs or Ribociclib finished pharmaceutical products to another nation, regulatory agencies frequently require a Ribociclib WC (written confirmation) as part of the regulatory process.
click here to find a list of Ribociclib suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Ribociclib as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ribociclib API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Ribociclib as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Ribociclib and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ribociclib NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ribociclib suppliers with NDC on PharmaCompass.
Ribociclib Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Ribociclib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ribociclib GMP manufacturer or Ribociclib GMP API supplier for your needs.
A Ribociclib CoA (Certificate of Analysis) is a formal document that attests to Ribociclib's compliance with Ribociclib specifications and serves as a tool for batch-level quality control.
Ribociclib CoA mostly includes findings from lab analyses of a specific batch. For each Ribociclib CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Ribociclib may be tested according to a variety of international standards, such as European Pharmacopoeia (Ribociclib EP), Ribociclib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ribociclib USP).