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1. Itf 2357
2. Itf2357
1. 199657-29-9
2. Givinostat Hcl
3. Givinostat (hydrochloride)
4. Itf 2357
5. Z02132r2qq
6. Unii-z02132r2qq
7. Itf2357 Hydrochloride
8. Itf-2357 Hydrochloride
9. Histone Deacetylase Inhibitor
10. Itf2357
11. Itf-2357
12. Carbamic Acid, N-[4-[(hydroxyamino)carbonyl]phenyl]-, [6-[(diethylamino)methyl]-2-naphthalenyl]methyl Ester, Hydrochloride (1:1)
13. [6-(diethylaminomethyl)naphthalen-2-yl]methyl N-[4-(hydroxycarbamoyl)phenyl]carbamate;hydrochloride
14. Carbamic Acid, N-(4-((hydroxyamino)carbonyl)phenyl)-, (6-((diethylamino)methyl)-2-naphthalenyl)methyl Ester, Hydrochloride (1:1)
15. (6-((diethylamino)methyl)naphthalen-2-yl)methyl (4-(hydroxycarbamoyl)phenyl)carbamate Hydrochloride
16. Mfcd28502062
17. {6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4-(hydroxycarbamoyl)phenyl]carbamate Hydrochloride
18. Itf 2357 Hydrochloride
19. Givinostat Monohydrochloride
20. Schembl23529420
21. Givinostat Hydrochloride Anhydrous
22. Chebi:231333
23. Ex-a8024
24. Zha65729
25. Hy-14842a
26. Akos030526700
27. Cs-4728
28. Sb16937
29. As-52365
30. En300-257964
31. P14959
32. Q27294820
33. Z2327390266
34. (6-((diethylamino)methyl)naphthalen-2-yl)methyl 4-(hydroxycarbamoyl)phenylcarbamate Hydrochloride
35. [6-[(diethylamino)methyl]-2-naphthalenyl]methyl N-[4-[(hydroxyamino)carbonyl]phenyl]carbamate Hydrochloride (1:1)
36. {6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4-(hydroxycarbamoyl)phenyl]carbamate--hydrogen Chloride
37. {6-[(diethylamino)methyl]naphthalen-2-yl}methyl N-[4-(hydroxycarbamoyl)phenyl]carbamate Hydrochloride
1. Givinostat
| Molecular Weight | 457.9 g/mol |
|---|---|
| Molecular Formula | C24H28ClN3O4 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 9 |
| Exact Mass | Da |
| Monoisotopic Mass | Da |
| Topological Polar Surface Area | 90.9 |
| Heavy Atom Count | 32 |
| Formal Charge | 0 |
| Complexity | 575 |
| 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 |
Histone Deacetylase Inhibitors
Compounds that inhibit HISTONE DEACETYLASES. This class of drugs may influence gene expression by increasing the level of acetylated HISTONES in specific CHROMATIN domains. (See all compounds classified as Histone Deacetylase Inhibitors.)
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37344
Submission : 2023-04-04
Status : Active
Type : II







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Regulatory Info : RX
Registration Country : USA
Brand Name : DUVYZAT
Dosage Form : SUSPENSION;ORAL
Dosage Strength : EQ 8.86MG BASE/ML
Packaging :
Approval Date : 2024-03-21
Application Number : 217865
Regulatory Info : RX
Registration Country : USA

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Regulatory Info : Marketed
Registration Country : Norway
Givinostathydrokloridmonohydrat
Brand Name : Duvyzat
Dosage Form : Oral Suspension
Dosage Strength : 8.86mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway

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Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Duvyzat
Dosage Form : Oral Suspension
Dosage Strength : 886mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Authorized
Registration Country : Spain
Givinostat Hydrochloride Monohydrate
Brand Name : Duvyzat
Dosage Form : Oral Suspension
Dosage Strength : 8.86MG
Packaging :
Approval Date : 29-07-2025
Application Number : 1251930001
Regulatory Info : Authorized
Registration Country : Spain

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Regulatory Info : Prescription
Registration Country : Denmark
Givinostat Hydrochloride Monohydrate
Brand Name : Duvyzat
Dosage Form : Oral Suspension
Dosage Strength : 8.86mg/mL
Packaging :
Approval Date : 06-06-2025
Application Number : 28107004623
Regulatory Info : Prescription
Registration Country : Denmark

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Regulatory Info : Approved
Registration Country : Sweden
Givinostat Hydrochloride Monohydrate
Brand Name : Duvyzat
Dosage Form : Oral Suspension
Dosage Strength : 8.86mg/ml
Packaging :
Approval Date : 06-06-2025
Application Number : 2.02E+13
Regulatory Info : Approved
Registration Country : Sweden

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Patents & EXCLUSIVITIES
Patent Expiration Date : 2032-02-03
US Patent Number : 9421184
Drug Substance Claim :
Drug Product Claim :
Application Number : 217865
Patent Use Code : U-3885
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2032-02-03

Patent Expiration Date : 2032-02-03
US Patent Number : 9867799
Drug Substance Claim :
Drug Product Claim :
Application Number : 217865
Patent Use Code : U-3885
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2032-02-03

Patent Expiration Date : 2036-10-28
US Patent Number : 10688047
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 217865
Patent Use Code : U-3885
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2036-10-28

Patent Expiration Date : 2027-01-15
US Patent Number : 7329689
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 217865
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2027-01-15

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PharmaCompass offers a list of Givinostat HCl API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Givinostat HCl manufacturer or Givinostat HCl supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Givinostat HCl manufacturer or Givinostat HCl supplier.
A Givinostat hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Givinostat hydrochloride, including repackagers and relabelers. The FDA regulates Givinostat hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Givinostat hydrochloride 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 Givinostat hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Givinostat hydrochloride supplier is an individual or a company that provides Givinostat hydrochloride active pharmaceutical ingredient (API) or Givinostat hydrochloride finished formulations upon request. The Givinostat hydrochloride suppliers may include Givinostat hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Givinostat hydrochloride suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Givinostat hydrochloride DMF (Drug Master File) is a document detailing the whole manufacturing process of Givinostat hydrochloride active pharmaceutical ingredient (API) in detail. Different forms of Givinostat hydrochloride DMFs exist exist since differing nations have different regulations, such as Givinostat hydrochloride USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Givinostat hydrochloride DMF submitted to regulatory agencies in the US is known as a USDMF. Givinostat hydrochloride USDMF includes data on Givinostat hydrochloride's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Givinostat hydrochloride USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Givinostat hydrochloride suppliers with USDMF on PharmaCompass.
Givinostat hydrochloride 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 Givinostat hydrochloride GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Givinostat hydrochloride GMP manufacturer or Givinostat hydrochloride GMP API supplier for your needs.
A Givinostat hydrochloride CoA (Certificate of Analysis) is a formal document that attests to Givinostat hydrochloride's compliance with Givinostat hydrochloride specifications and serves as a tool for batch-level quality control.
Givinostat hydrochloride CoA mostly includes findings from lab analyses of a specific batch. For each Givinostat hydrochloride 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.
Givinostat hydrochloride may be tested according to a variety of international standards, such as European Pharmacopoeia (Givinostat hydrochloride EP), Givinostat hydrochloride JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Givinostat hydrochloride USP).