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INTERMEDIATES SUPPLIERS
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
(S)-2-(tert-butoxy carbonylamino)-3-(4-carbamoyl-2...
CAS Number : 623950-02-7
End Use API : Eluxadoline
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
Boc-3-Iodo-L-alanine methyl ester
CAS Number : 93267-04-0
End Use API : Eluxadoline
About The Company : Aarti Pharmalab, earlier the pharma division of Aarti Industries, is a leading Indian manufacturer of APIs. It has dedicated facilities to manufacture HPAPIs, c...
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US Patents
Patent Expiration Date : 2028-07-07
US Patent Number : 9789125
Drug Substance Claim :
Drug Product Claim : Y
Application Number : 206940
Patent Use Code : U-1709
Delist Requested :
Patent Use Description : TREATMENT OF IRRITABLE...
Patent Expiration Date : 2028-07-07
Patent Expiration Date : 2025-03-14
US Patent Number : 9205076
Drug Substance Claim :
Drug Product Claim :
Application Number : 206940
Patent Use Code : U-1709
Delist Requested :
Patent Use Description : TREATMENT OF IRRITABLE...
Patent Expiration Date : 2025-03-14
Patent Expiration Date : 2025-03-14
US Patent Number : 8772325
Drug Substance Claim :
Drug Product Claim :
Application Number : 206940
Patent Use Code : U-1709
Delist Requested :
Patent Use Description : TREATMENT OF IRRITABLE...
Patent Expiration Date : 2025-03-14
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ABOUT THIS PAGE
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.
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.
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.
A Eluxadoline written confirmation (Eluxadoline WC) is an official document issued by a regulatory agency to a Eluxadoline manufacturer, verifying that the manufacturing facility of a Eluxadoline active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eluxadoline APIs or Eluxadoline finished pharmaceutical products to another nation, regulatory agencies frequently require a Eluxadoline WC (written confirmation) as part of the regulatory process.
click here to find a list of Eluxadoline suppliers with Written Confirmation (WC) on PharmaCompass.
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).
The FDA updates the NDC directory daily. The NDC numbers for Eluxadoline API and other APIs are published in this directory by the FDA.
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.
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 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.
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).
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