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

Difelikefalin manufacturers, exporters & distributors 1

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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 USDMF

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

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

click here to find a list of Difelikefalin suppliers with USDMF 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 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 as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Difelikefalin GMP

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

Difelikefalin CoA

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

Difelikefalin CoA mostly includes findings from lab analyses of a specific batch. For each Difelikefalin 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 may be tested according to a variety of international standards, such as European Pharmacopoeia (Difelikefalin EP), Difelikefalin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Difelikefalin 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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