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Looking for 1025216-57-2 / Volixibat API manufacturers, exporters & distributors?

Volixibat manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Volixibat

Synonyms

1025216-57-2, Sar-548304 free acid, X2jz0451h8, N-(3-o-benzyl-6-o-sulfo-beta-d-glucopyranosyl)-n'-{3-[(3s,4r,5r)-3-butyl-7-(dimethylamino)-3-ethyl-4-hydroxy-1,1-dioxo-2,3,4,5-tetrahydro-1h-1lambda6-benzothiepin-5-yl]phenyl}urea, Volixibat [usan:inn], Unii-x2jz0451h8

Cas Number

1025216-57-2

Unique Ingredient Identifier (UNII)

X2JZ0451H8

About Volixibat

Volixibat, also known as SHP626 or LUM002, is an investigational drug that will potentially be used for the treatment of Non-Alcoholic Steatohepatitis (NASH). If approved for use, it will be the first available agent for the treatment of NASH. Volixibat is a selective inhibitor of the apical sodium-dependent bile acid transporter (ASBT), a transmembrane protein primarily expressed by enterocytes of the ileum. Also known as the ileal bile acid transporter (IBAT), ASBT is primarily responsible for the enterohepatic recirculation of bile acids and ultimately for hepatic lipid and glucose metabolism. Inhibiting this enzyme results in a decrease of bile acids returning to the liver, which is helpful for the treatment of NASH as abnormal cholesterol metabolism and accumulation of free cholesterol in the liver have been implicated in its pathogenesis. According to Shire, the pharmaceutical manufacturer of Volixibat, it has been granted fast track status by the Food and Drug Administration due to promising initial results and a need for therapeutic treatments for NASH.

Volixibat Manufacturers

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

Volixibat Suppliers

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

Volixibat GMP

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

Volixibat CoA

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

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

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