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Looking for 864821-90-9 / Eluxadoline API manufacturers, exporters & distributors?

Eluxadoline manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Eluxadoline

Synonyms

864821-90-9, Viberzi, Truberzi, Jnj-27018966, Eluxadoline [usan], Jnj 27018966

Cas Number

864821-90-9

Unique Ingredient Identifier (UNII)

45TPJ4MBQ1

About Eluxadoline

Eluxadoline is a mixed mu-opioid receptor agonist, kappa-opioid receptor agonist, and a-delta opioid receptor antagonist indicated for use in diarrhea-predominant irritable bowel syndrome (IBS-D). The mu-, kappa-, and delta-opioid receptors mediate endogenous and exogenous opioid response in the central nervous system and peripherally in the gastrointestinal system. Agonism of peripheral mu-opioid receptors results in reduced colonic motility, while antagonism of central delta-opioid receptors results in improved analgesia, making eluxadoline usable for the symptoms of both pain and diarrhea characteristic of IBS-D. Marketed under the tradename Viberzi (FDA), eluxadoline is an antimotility agent that decreases bowel contractions, inhibits colonic transit, and reduces uid/ion secretion resulting in improved symptoms of abdominal pain and reductions in the Bristol Stool Scale.

Eluxadoline Manufacturers

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

Eluxadoline Suppliers

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

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

Eluxadoline USDMF

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

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

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

Eluxadoline 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 Eluxadoline as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Eluxadoline GMP

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

Eluxadoline CoA

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

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

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