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Chemistry

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Also known as: Cr845 acetate, Cr-845 acetate, 1024829-44-4, Unii-0p70ar5byb, 0p70ar5byb, Korsuva
Molecular Formula
C38H57N7O8
Molecular Weight
739.9  g/mol
InChI Key
MZWHRPKAHCWTOI-KGURMGBCSA-N
FDA UNII
0P70AR5BYB

Difelikefalin Acetate
DIFELIKEFALIN ACETATE is a Protein drug with a maximum clinical trial phase of IV (across all indications) that was first approved in 2021 and is indicated for chronic kidney disease and pruritus.
1 2D Structure

Difelikefalin Acetate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
acetic acid;4-amino-1-[(2R)-6-amino-2-[[(2R)-2-[[(2R)-2-[[(2R)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid
2.1.2 InChI
InChI=1S/C36H53N7O6.C2H4O2/c1-24(2)21-29(32(45)40-28(15-9-10-18-37)34(47)43-19-16-36(39,17-20-43)35(48)49)42-33(46)30(23-26-13-7-4-8-14-26)41-31(44)27(38)22-25-11-5-3-6-12-25;1-2(3)4/h3-8,11-14,24,27-30H,9-10,15-23,37-39H2,1-2H3,(H,40,45)(H,41,44)(H,42,46)(H,48,49);1H3,(H,3,4)/t27-,28-,29-,30-;/m1./s1
2.1.3 InChI Key
MZWHRPKAHCWTOI-KGURMGBCSA-N
2.2 Other Identifiers
2.2.1 UNII
0P70AR5BYB
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 4-piperidinecarboxylic Acid, 4-amino-1-((2r)-6-amino-2-(((2r)-2-(((2r)-2-(((2r)-2-amino-1-oxo-3-phenylpropyl)amino)-1-oxo-3-phenylpropyl)amino)-4-methyl-1-oxopentyl)amino)-1-oxohexyl)-

2. Difelikefalin

3. Korsuva

4. N-((2r)-1-(((2r)-1-(((2r)-6-amino-1-(4-amino-4-carboxy-1-piperidinyl)-1-oxo-2-hexanyl)amino)-4-methyl-1-oxo-2-pentanyl)amino)-1-oxo-3-phenyl-2-propanyl)-d-phenylalaninamide

2.3.2 Depositor-Supplied Synonyms

1. Cr845 Acetate

2. Cr-845 Acetate

3. 1024829-44-4

4. Unii-0p70ar5byb

5. 0p70ar5byb

6. Korsuva

7. 4-amino-1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysl)-piperidine-4-carboxylic Acid, Acetate Salt

8. Acetic Acid;4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic Acid

9. Difelikefalin (acetate)

10. Chembl5315123

11. Hy-17609c

12. 1024828-77-0 , Difelikefalin

13. Difelikefalin Acetate [who-dd]

14. Ac-38232

15. Ts-10624

16. Difelikefalin Acetate [orange Book]

17. 4-amino-1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysyl)piperidine-4-carboxylic Acid Acetate

18. N1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysyl)-4-amino-4-piperidinecarboxylic Acid Acetate (1:)

19. N1-(d-phenylalanyl-d-phenylalanyl-d-leucyl-d-lysyl)-4-amino-4-piperidinecarboxylic Acid Acetate (1:?)

2.3.3 Other Synonyms

1. Difelikefalin

2.4 Create Date
2015-09-11
3 Chemical and Physical Properties
Molecular Weight 739.9 g/mol
Molecular Formula C38H57N7O8
Hydrogen Bond Donor Count8
Hydrogen Bond Acceptor Count11
Rotatable Bond Count18
Exact Mass Da
Monoisotopic Mass Da
Topological Polar Surface Area260
Heavy Atom Count53
Formal Charge0
Complexity1110
Isotope Atom Count0
Defined Atom Stereocenter Count4
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2

API Reference Price

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13-Jul-2023
04-May-2024
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Looking for 1024829-44-4 / Difelikefalin Acetate API manufacturers, exporters & distributors?

Difelikefalin Acetate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Difelikefalin Acetate

Synonyms

Cr845 acetate, Cr-845 acetate, 1024829-44-4, Unii-0p70ar5byb, 0p70ar5byb, Korsuva

Cas Number

1024829-44-4

Unique Ingredient Identifier (UNII)

0P70AR5BYB

About Difelikefalin Acetate

DIFELIKEFALIN ACETATE is a Protein drug with a maximum clinical trial phase of IV (across all indications) that was first approved in 2021 and is indicated for chronic kidney disease and pruritus.

Difelikefalin Acetate Manufacturers

A Difelikefalin Acetate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Difelikefalin Acetate, including repackagers and relabelers. The FDA regulates Difelikefalin Acetate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Difelikefalin Acetate 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 Difelikefalin Acetate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Difelikefalin Acetate Suppliers

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

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

Difelikefalin Acetate USDMF

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

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

click here to find a list of Difelikefalin Acetate suppliers with USDMF on PharmaCompass.

Difelikefalin Acetate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Difelikefalin Acetate Drug Master File in Japan (Difelikefalin Acetate JDMF) empowers Difelikefalin Acetate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Difelikefalin Acetate JDMF during the approval evaluation for pharmaceutical products. At the time of Difelikefalin Acetate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Difelikefalin Acetate suppliers with JDMF on PharmaCompass.

Difelikefalin Acetate 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 Difelikefalin Acetate as an active pharmaceutical ingredient (API).

Finished drug products

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

click here to find a list of Difelikefalin Acetate suppliers with NDC on PharmaCompass.

Difelikefalin Acetate GMP

Difelikefalin Acetate 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 Difelikefalin Acetate 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 Difelikefalin Acetate GMP manufacturer or Difelikefalin Acetate GMP API supplier for your needs.

Difelikefalin Acetate CoA

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

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

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