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Looking for 59729-37-2 / Fexinidazole API manufacturers, exporters & distributors?

Fexinidazole manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Fexinidazole

Synonyms

59729-37-2, 1-methyl-2-((4-(methylthio)phenoxy)methyl)-5-nitro-1h-imidazole, Hoe-239, Hoe 239, 1-methyl-2-[(4-methylsulfanylphenoxy)methyl]-5-nitroimidazole, 306erl82ir

Cas Number

59729-37-2

Unique Ingredient Identifier (UNII)

306ERL82IR

About Fexinidazole

Human African trypanosomiasis (HAT, also colloquially referred to as sleeping sickness), caused by T. brucei gambiense and T. brucei rhodesiense, remains a moderate risk (>1/10,000 inhabitants per year in endemic areas) despite focussed control efforts. Transmitted by the bite of an infected tsetse fly, HAT is biphasic with a first (hemolymphatic) stage that progresses to a second (meningoencephalitic) stage in which patients experience progressively worsening neurological symptoms and eventually die if left untreated. Historical treatment options for meningoencephalitic HAT include [melarsoprol], [eflornithine], and [nifurtimox]/[eflornithine] combination therapy (NECT), though [melarsoprol] is highly toxic and each treatment requires lengthy infusions that are difficult to administer in resource-limited settings. Fexinidazole, which was originally developed in the 1970s/80s by Hoechst AG and subsequently rediscovered through the Drugs for Neglected Diseases Initiative (DNDi) in 2005, is the first all-oral treatment for first and second stage HAT caused by T. brucei gambiense. Fexinidazole received a positive opinion from the European Medicines Agency (EMA) in November 2018 and was approved by the FDA on July 16, 2021. It is currently marketed by Sanofi-Aventis.

Fexinidazole Manufacturers

A Fexinidazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fexinidazole, including repackagers and relabelers. The FDA regulates Fexinidazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fexinidazole API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

Fexinidazole Suppliers

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

Fexinidazole 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 Fexinidazole as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Fexinidazole GMP

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

Fexinidazole CoA

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

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

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