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Chemistry

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Also known as: 960055-56-5, Panobinostat lactate [jan], Panobinostat (lactate), Hn0t99oo4v, Panobinostat lactate anhydrous, Chebi:85991
Molecular Formula
C24H29N3O5
Molecular Weight
439.5  g/mol
InChI Key
XVDWNSFFSMWXJJ-ASTDGNLGSA-N
FDA UNII
HN0T99OO4V

Panobinostat lactate
Panobinostat Lactate is the lactate form of panobinostat, a pan histone deacetylase (HDAC) inhibitor, with potential antineoplastic activity. Upon administration, panobinostat selectively targets, binds to and inhibits HDAC, which induces hyperacetylation of core histone proteins. The accumulation of highly acetylated histones leads to chromatin remodeling, an altered pattern of gene expression, inhibition of tumor oncogene transcription and the selective transcription of tumor suppressor genes. This results in the inhibition of tumor cell division and the induction of tumor cell apoptosis. HDAC, upregulated in many tumor cell types, is an enzyme family that deacetylates histone proteins.
1 2D Structure

Panobinostat lactate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(E)-N-hydroxy-3-[4-[[2-(2-methyl-1H-indol-3-yl)ethylamino]methyl]phenyl]prop-2-enamide;2-hydroxypropanoic acid
2.1.2 InChI
InChI=1S/C21H23N3O2.C3H6O3/c1-15-18(19-4-2-3-5-20(19)23-15)12-13-22-14-17-8-6-16(7-9-17)10-11-21(25)24-26;1-2(4)3(5)6/h2-11,22-23,26H,12-14H2,1H3,(H,24,25);2,4H,1H3,(H,5,6)/b11-10+;
2.1.3 InChI Key
XVDWNSFFSMWXJJ-ASTDGNLGSA-N
2.1.4 Canonical SMILES
CC1=C(C2=CC=CC=C2N1)CCNCC3=CC=C(C=C3)C=CC(=O)NO.CC(C(=O)O)O
2.1.5 Isomeric SMILES
CC1=C(C2=CC=CC=C2N1)CCNCC3=CC=C(C=C3)/C=C/C(=O)NO.CC(C(=O)O)O
2.2 Other Identifiers
2.2.1 UNII
HN0T99OO4V
2.3 Synonyms
2.3.1 Depositor-Supplied Synonyms

1. 960055-56-5

2. Panobinostat Lactate [jan]

3. Panobinostat (lactate)

4. Hn0t99oo4v

5. Panobinostat Lactate Anhydrous

6. Chebi:85991

7. 960055-56-5 (lactate)

8. (e)-n-hydroxy-3-(4-(((2-(2-methyl-1h-indol-3-yl)ethyl)amino)methyl)phenyl)acrylamide 2-hydroxypropanoate

9. Farydak (tn)

10. Panobinostat Lactate (jan)

11. (2e)-n-hydroxy-3-(4-(((2-(2-methyl-1h-indol-3-yl)ethyl)amino(methyl)phenyl)prop-2-enamide Mono((2rs)-2-hydroxypropanoate)

12. Propanoic Acid, 2-hydroxy-, Compd. With (2e)-n-hydroxy-3-(4-(((2-(2-methyl-1h-indol-3-yl)ethyl)amino)methyl)phenyl)-2-propenamide (1:1)

13. (2e)-n-hydroxy-3-[4-({[2-(2-methyl-1h-indol-3-yl)ethyl]amino}methyl)phenyl]acrylamide Lactic Acid

14. Unii-hn0t99oo4v

15. Propanoic Acid, 2-hydroxy-, Compd. With (2e)-n-hydroxy-3-[4-[[[2-(2-methyl-1h-indol-3-yl)ethyl]amino]methyl]phenyl]-2-propenamide (1:1)

16. Panobinostat Dl-lactate

17. Schembl2315056

18. Schembl2315067

19. Chembl3545368

20. Dtxsid401026247

21. Bcp25197

22. Ex-a2659

23. Hy-10224a

24. Panobinostat Lactate [who-dd]

25. Panobinostat Lactate [orange Book]

26. Cs-0030991

27. D10019

28. A917191

29. Q27158837

30. (2e)-n-hydroxy-3-[4-({[2-(2-methyl-1h-indol-3-yl)ethyl]amino}methyl)phenyl]prop-2-enamide; 2-hydroxypropanoic Acid

31. (e)-n-hydroxy-3-(4-(((2-(2-methyl-1h-indol-3-yl)ethyl)amino)methyl)phenyl)acrylamide2-hydroxypropanoate

32. (e)-n-hydroxy-3-[4-[[2-(2-methyl-1h-indol-3-yl)ethylamino]methyl]phenyl]prop-2-enamide;2-hydroxypropanoic Acid

33. 2-hydroxypropanoic Acid--(2e)-n-hydroxy-3-[4-({[2-(2-methyl-1h-indol-3-yl)ethyl]amino}methyl)phenyl]prop-2-enamide (1/1)

34. N-({4-[(1e)-3-(hydroxyamino)-3-oxoprop-1-en-1-yl]phenyl}methyl)-2-(2-methyl-1h-indol-3-yl)ethan-1-aminium 2-hydroxypropanoate

35. N-hydroxy-3-[4-[[[2-(2-methyl-1h-indol-3-yl) Ethyl]amino]methyl]phenyl]-2e-2-propenamide Dl-lactate Salt

36. N-hydroxy-3-[4-[[[2-(2-methyl-1h-indol-3-yl)ethyl]amino]methyl]phenyl]-2e-2-propenamide Dl-lactate Salt

37. N-hydroxy-3-[4-[[[2-(2-methyl-1h-indol-3-yl)ethyl]amino]methyl]phenyl]-2e-2-propenamide Lactate Salt

2.4 Create Date
2008-02-11
3 Chemical and Physical Properties
Molecular Weight 439.5 g/mol
Molecular Formula C24H29N3O5
Hydrogen Bond Donor Count6
Hydrogen Bond Acceptor Count6
Rotatable Bond Count8
Exact Mass439.21072103 g/mol
Monoisotopic Mass439.21072103 g/mol
Topological Polar Surface Area135 Ų
Heavy Atom Count32
Formal Charge0
Complexity533
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Indication

Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.

Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.


5 Pharmacology and Biochemistry
5.1 ATC Code

L01XH03


DRUG PRODUCT COMPOSITIONS

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DOSAGE - CAPSULE;ORAL - EQ 10MG BASE

USFDA APPLICATION NUMBER - 205353

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DOSAGE - CAPSULE;ORAL - EQ 15MG BASE

USFDA APPLICATION NUMBER - 205353

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DOSAGE - CAPSULE;ORAL - EQ 20MG BASE

USFDA APPLICATION NUMBER - 205353

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ABOUT THIS PAGE

Panobinostat lactate Manufacturers

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

Panobinostat lactate Suppliers

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

click here to find a list of Panobinostat lactate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Panobinostat lactate USDMF

A Panobinostat lactate DMF (Drug Master File) is a document detailing the whole manufacturing process of Panobinostat lactate active pharmaceutical ingredient (API) in detail. Different forms of Panobinostat lactate DMFs exist exist since differing nations have different regulations, such as Panobinostat lactate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Panobinostat lactate DMF submitted to regulatory agencies in the US is known as a USDMF. Panobinostat lactate USDMF includes data on Panobinostat lactate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Panobinostat lactate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Panobinostat lactate suppliers with USDMF on PharmaCompass.

Panobinostat lactate WC

A Panobinostat lactate written confirmation (Panobinostat lactate WC) is an official document issued by a regulatory agency to a Panobinostat lactate manufacturer, verifying that the manufacturing facility of a Panobinostat lactate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Panobinostat lactate APIs or Panobinostat lactate finished pharmaceutical products to another nation, regulatory agencies frequently require a Panobinostat lactate WC (written confirmation) as part of the regulatory process.

click here to find a list of Panobinostat lactate suppliers with Written Confirmation (WC) on PharmaCompass.

Panobinostat lactate 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 Panobinostat lactate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Panobinostat lactate 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 Panobinostat lactate 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 Panobinostat lactate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Panobinostat lactate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Panobinostat lactate suppliers with NDC on PharmaCompass.

Panobinostat lactate GMP

Panobinostat lactate 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 Panobinostat lactate 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 Panobinostat lactate GMP manufacturer or Panobinostat lactate GMP API supplier for your needs.

Panobinostat lactate CoA

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

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

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