API Suppliers
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Listed Suppliers
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PharmaCompass offers a list of Eliglustat 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 Eliglustat manufacturer or Eliglustat supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Eliglustat manufacturer or Eliglustat supplier.
PharmaCompass also assists you with knowing the Eliglustat API Price utilized in the formulation of products. Eliglustat API Price is not always fixed or binding as the Eliglustat Price is obtained through a variety of data sources. The Eliglustat Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Eliglustat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eliglustat, including repackagers and relabelers. The FDA regulates Eliglustat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eliglustat 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 Eliglustat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eliglustat supplier is an individual or a company that provides Eliglustat active pharmaceutical ingredient (API) or Eliglustat finished formulations upon request. The Eliglustat suppliers may include Eliglustat API manufacturers, exporters, distributors and traders.
click here to find a list of Eliglustat suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Eliglustat DMF (Drug Master File) is a document detailing the whole manufacturing process of Eliglustat active pharmaceutical ingredient (API) in detail. Different forms of Eliglustat DMFs exist exist since differing nations have different regulations, such as Eliglustat USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Eliglustat DMF submitted to regulatory agencies in the US is known as a USDMF. Eliglustat USDMF includes data on Eliglustat's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Eliglustat USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Eliglustat suppliers with USDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Eliglustat Drug Master File in Korea (Eliglustat KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Eliglustat. The MFDS reviews the Eliglustat KDMF as part of the drug registration process and uses the information provided in the Eliglustat KDMF to evaluate the safety and efficacy of the drug.
After submitting a Eliglustat KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Eliglustat API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Eliglustat suppliers with KDMF on PharmaCompass.
A Eliglustat written confirmation (Eliglustat WC) is an official document issued by a regulatory agency to a Eliglustat manufacturer, verifying that the manufacturing facility of a Eliglustat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Eliglustat APIs or Eliglustat finished pharmaceutical products to another nation, regulatory agencies frequently require a Eliglustat WC (written confirmation) as part of the regulatory process.
click here to find a list of Eliglustat 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 Eliglustat as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Eliglustat 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 Eliglustat 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 Eliglustat and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Eliglustat NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Eliglustat suppliers with NDC on PharmaCompass.
Eliglustat 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 Eliglustat 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 Eliglustat GMP manufacturer or Eliglustat GMP API supplier for your needs.
A Eliglustat CoA (Certificate of Analysis) is a formal document that attests to Eliglustat's compliance with Eliglustat specifications and serves as a tool for batch-level quality control.
Eliglustat CoA mostly includes findings from lab analyses of a specific batch. For each Eliglustat 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.
Eliglustat may be tested according to a variety of international standards, such as European Pharmacopoeia (Eliglustat EP), Eliglustat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eliglustat USP).