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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

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NDC API

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API REF. PRICE (USD/KG)

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DRUG PRODUCT COMPOSITIONS

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USP

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Chemistry

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Also known as: 926037-48-1, Supect, Iy-5511, Radotinib [inn], Iy5511, Radotinib(iy-5511)
Molecular Formula
C27H21F3N8O
Molecular Weight
530.5  g/mol
InChI Key
DUPWHXBITIZIKZ-UHFFFAOYSA-N
FDA UNII
I284LJY110

Radotinib
Radotinib is under investigation for the treatment of Leukemia, Myelogenous, Chronic, BCR-ABL Positive.
1 2D Structure

Radotinib

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
4-methyl-N-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyrazin-2-ylpyrimidin-2-yl)amino]benzamide
2.1.2 InChI
InChI=1S/C27H21F3N8O/c1-16-3-4-18(9-23(16)37-26-33-6-5-22(36-26)24-13-31-7-8-32-24)25(39)35-20-10-19(27(28,29)30)11-21(12-20)38-14-17(2)34-15-38/h3-15H,1-2H3,(H,35,39)(H,33,36,37)
2.1.3 InChI Key
DUPWHXBITIZIKZ-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=C(C=C(C=C1)C(=O)NC2=CC(=CC(=C2)C(F)(F)F)N3C=C(N=C3)C)NC4=NC=CC(=N4)C5=NC=CN=C5
2.2 Other Identifiers
2.2.1 UNII
I284LJY110
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-methyl-n-(3-(4-methylimidazol-1-yl)-5-trifluoromethylphenyl)-3-(4-pyrazin-2-ylpyrimidin-2-ylamino)benzamide

2. 4-methyl-n-(3-(4-methylimidazol-1-yl)-5-trifluoromethylphenyl)-3-(4-pyrazin-2-ylpyrimidin-2-ylamino)benzamide Hydrochloride

3. Iy5511

4. Iy5511hcl

2.3.2 Depositor-Supplied Synonyms

1. 926037-48-1

2. Supect

3. Iy-5511

4. Radotinib [inn]

5. Iy5511

6. Radotinib(iy-5511)

7. 4-methyl-n-[3-(4-methylimidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[(4-pyrazin-2-ylpyrimidin-2-yl)amino]benzamide

8. I284ljy110

9. 926037-48-1 (free Base)

10. 4-methyl-n-[3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-{[4-(pyrazin-2-yl)pyrimidin-2-yl]amino}benzamide

11. 4-methyl-n-(3-(4-methylimidazol-1-yl)-5-trifluoromethylphenyl)-3-(4-(pyrazin-2-yl)pyrimidin-2-ylamino)benzamide

12. Iy5511hcl

13. 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(pyrazin-2-yl)pyrimidin-2-yl)amino)benzamide

14. Unii-i284ljy110

15. Radotinib [mi]

16. Radotinib (iy-5511)

17. Radotinib; Iy-5511;

18. Radotinib [who-dd]

19. Gtpl7814

20. Schembl3359952

21. Chembl4297524

22. Dtxsid90239069

23. Bcp12554

24. Ex-a1035

25. Mfcd27956910

26. Nsc800989

27. S8134

28. Zinc59749972

29. Akos026750428

30. Akos032950010

31. Ccg-269914

32. Db12323

33. Iy 5511

34. Nsc-800989

35. Sb11083

36. Ncgc00390586-01

37. Ncgc00481590-01

38. Ac-30633

39. As-55884

40. Da-40474

41. Kb-146009

42. B5846

43. Ft-0700508

44. A13029

45. 2?,3?,17?-trihydroxy-7?-6-oxo-5?-androstan

46. J-690392

47. Q15269680

48. Benzamide, 4-methyl-n-(3-(4-methyl-1h-imidazol-1-yl)-5-(trifluoromethyl)phenyl)-3-((4-(2-pyrazinyl)-2-pyrimidinyl)amino)-

2.4 Create Date
2007-05-22
3 Chemical and Physical Properties
Molecular Weight 530.5 g/mol
Molecular Formula C27H21F3N8O
XLogP33.9
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count10
Rotatable Bond Count6
Exact Mass530.17904181 g/mol
Monoisotopic Mass530.17904181 g/mol
Topological Polar Surface Area111 Ų
Heavy Atom Count39
Formal Charge0
Complexity818
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Radotinib is indicated for the treatment of different types of cancer, most notably Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) with resistance or intolerance of other Bcr-Abl tyrosine-kinase inhibitors, such as patients resistant or intolerant to imatinib.


5 Pharmacology and Biochemistry
5.1 Mechanism of Action

Philadelphia chromosome positive (Ph+) leukemia is driven by the constitutive enzymatic activity of the BCR-ABL1 fusion kinase. Tyrosine kinase inhibitors (TKIs) that block the activity of BCR-ABL1 are successfully used clinically to treat chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).


ABOUT THIS PAGE

Looking for 926037-48-1 / Radotinib API manufacturers, exporters & distributors?

Radotinib manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Radotinib 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 Radotinib manufacturer or Radotinib supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Radotinib manufacturer or Radotinib supplier.

PharmaCompass also assists you with knowing the Radotinib API Price utilized in the formulation of products. Radotinib API Price is not always fixed or binding as the Radotinib Price is obtained through a variety of data sources. The Radotinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Radotinib

Synonyms

926037-48-1, Supect, Iy-5511, Radotinib [inn], Iy5511, Radotinib(iy-5511)

Cas Number

926037-48-1

Unique Ingredient Identifier (UNII)

I284LJY110

About Radotinib

Radotinib is under investigation for the treatment of Leukemia, Myelogenous, Chronic, BCR-ABL Positive.

Radotinib Manufacturers

A Radotinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Radotinib, including repackagers and relabelers. The FDA regulates Radotinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Radotinib API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Radotinib Suppliers

A Radotinib supplier is an individual or a company that provides Radotinib active pharmaceutical ingredient (API) or Radotinib finished formulations upon request. The Radotinib suppliers may include Radotinib API manufacturers, exporters, distributors and traders.

Radotinib KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Radotinib Drug Master File in Korea (Radotinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Radotinib. The MFDS reviews the Radotinib KDMF as part of the drug registration process and uses the information provided in the Radotinib KDMF to evaluate the safety and efficacy of the drug.

After submitting a Radotinib 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 Radotinib API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Radotinib suppliers with KDMF on PharmaCompass.

Radotinib GMP

Radotinib 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 Radotinib 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 Radotinib GMP manufacturer or Radotinib GMP API supplier for your needs.

Radotinib CoA

A Radotinib CoA (Certificate of Analysis) is a formal document that attests to Radotinib's compliance with Radotinib specifications and serves as a tool for batch-level quality control.

Radotinib CoA mostly includes findings from lab analyses of a specific batch. For each Radotinib 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.

Radotinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Radotinib EP), Radotinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Radotinib 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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