loader
Please Wait
Applying Filters...
Close
4

Bora CDMO Bora CDMO

X
menu

    Market Place

    Market Place

    Post Enquiry

    Post Enquiry
    menu

    List of Drug Master Files (JDMF) for Difelikefalin Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

    Client Email Product
    Menu

    Difelikefalin

    APIs // Active Pharmaceutical Ingredients

    DEVELOPMENTS

    DOSSIERs // Finished Dosage Forms

    MARKET PLACE

    PATENTS

    DIGITAL CONTENT

    PharmaCompass

    PharmaCompass Sponsored Ads

    Athena Pharmaceutiques is a Partner of Choice for Drug Delivery & Life Cycle Management.

    Left Arrow
    Right Arrow
    Filters Filter
    Cross PopUp
    FILTER :

    filter

    01 PolyPeptide Laboratories France SAS (1)

    filter

    01 Difelikefalin (1)

    filter

    01 Switzerland (1)

    ListList of Suppliers
    refreshReset Filter
    refresh Reset Filter
    Price Info Price Info
    product-page Product Main Page

    PolyPeptide Laboratories France SAS

    Contact Supplier
    • FDA
    • EDQM
    • WHO-GMP
    Virtual Booth Upload your Marketing & Sales content on your company Virtual Booth, click HERE
    Post an Enquiry Post an Enquiry
    Flag Switzerland
    Virtual Booth Virtual Booth
    Digital Content Digital Content

    Difelikefalin

    PDF Supplier PDF
    URL Supplier Web Content
    304MF10128
    7 rue de Boulogne 67100 Strasbourg,...
    2023-07-19
    2022-09-08
    ASK
    US
    PHARMACOMPASS
    Upload
    your Marketing & Sales content

    Looking for 1024828-77-0 / Difelikefalin API manufacturers, exporters & distributors?

    Difelikefalin manufacturers, exporters & distributors 1

    78

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

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

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

    API | Excipient name

    Difelikefalin

    Synonyms

    1024828-77-0, Cr845, Difelikefalin [inn], Mr13a9, Cr-845, Korsuva

    Cas Number

    1024828-77-0

    Unique Ingredient Identifier (UNII)

    NA1U919MRO

    About Difelikefalin

    Difelikefalin (CR845) is an agonist of kappa opioid receptors (KORs) useful in the treatment of pruritus secondary to chronic kidney disease. KORs were first associated with itching in 1984. Further investigations revealed that dynorphins, endogenous agonists of KORs, work to inhibit the itching sensation at the spinal cord level, and scratching could be elicited in mouse models with the administration of KOR antagonists. These revelations led to the study of KOR agonists as a potential treatment option in patients suffering from pruritic conditions. Pruritus associated with chronic kidney disease (also called uremic pruritus) affects 50-60% of all patients on dialysis and 25% of non-dialysis patients with chronic kidney disease. The clinical burden of uremic pruritus in this patient population is being increasingly recognized as contributing to a significant reduction in patient quality of life, poor outcomes, and even mortality. Options for therapy are limited - with no FDA-approved treatments, off-label [gabapentin] was the most evidence-based and widely available treatment. Difelikefalin received FDA approval in August 2021 (under the brand name Korsuva), becoming the first FDA-approved therapy for patients with chronic kidney disease suffering from uremic pruritus.

    Difelikefalin Manufacturers

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

    Difelikefalin Suppliers

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

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

    Difelikefalin 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 Drug Master File in Japan (Difelikefalin JDMF) empowers Difelikefalin 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Difelikefalin 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 suppliers with JDMF on PharmaCompass.

    Difelikefalin Manufacturers | Traders | Suppliers

    Difelikefalin Manufacturers, Traders, Suppliers 1
    51

    We have 1 companies offering Difelikefalin

    Get in contact with the supplier of your choice:

    1. PolyPeptide Group
    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.
    Post Enquiry
    POST ENQUIRY