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Looking for 158440-71-2 / Irofulven API manufacturers, exporters & distributors?

Irofulven manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Irofulven

Synonyms

Hmaf, Mgi 114, 158440-71-2, 6-hydroxymethylacylfulvene, (-)-irofulven, Mgi-114

Cas Number

158440-71-2

Unique Ingredient Identifier (UNII)

6B799IH05A

About Irofulven

A novel anti-cancer compound synthesized by scientists at the University of California, San Diego more than a decade ago from toxins of the poisonous jack-o-lantern mushroom, has been granted fast track status by the U.S. Food and Drug Administration (FDA) after demonstrating promise against one of the most deadly cancers. MGI-114 (Irofulven) is currently being developed by MGI PHARMA, Inc., an emerging oncology-focused pharmaceutical company based in Minneapolis. Phase III clinical trials involving the drug have been underway since early 2001 at sites in the U.S. and Europe.

Irofulven Manufacturers

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

Irofulven Suppliers

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

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

Irofulven USDMF

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

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

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

Irofulven GMP

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

Irofulven CoA

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

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

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