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Looking for 68278-23-9 / Eflornithine API manufacturers, exporters & distributors?

Eflornithine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Eflornithine

Synonyms

68278-23-9, Eflornithine hcl, Dfmo, Dl-alpha-difluoromethylornithine hydrochloride, Eflornithinehydrochloride, 2-(difluoromethyl)-dl-ornithine monohydrochloride

Cas Number

68278-23-9

Unique Ingredient Identifier (UNII)

UO07O10TCJ

About Eflornithine

An inhibitor of ornithine decarboxylase, the rate limiting enzyme of the polyamine biosynthetic pathway.

Eflornithine HCl Manufacturers

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

Eflornithine HCl Suppliers

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

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

Eflornithine HCl USDMF

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

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

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

Eflornithine HCl WC

A Eflornithine HCl written confirmation (Eflornithine HCl WC) is an official document issued by a regulatory agency to a Eflornithine HCl manufacturer, verifying that the manufacturing facility of a Eflornithine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eflornithine HCl APIs or Eflornithine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Eflornithine HCl WC (written confirmation) as part of the regulatory process.

click here to find a list of Eflornithine HCl suppliers with Written Confirmation (WC) on PharmaCompass.

Eflornithine HCl 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 Eflornithine HCl as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Eflornithine HCl GMP

Eflornithine HCl 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 Eflornithine HCl 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 Eflornithine HCl GMP manufacturer or Eflornithine HCl GMP API supplier for your needs.

Eflornithine HCl CoA

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

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

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