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PharmaCompass offers a list of Elamipretide 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 Elamipretide manufacturer or Elamipretide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Elamipretide manufacturer or Elamipretide supplier.
PharmaCompass also assists you with knowing the Elamipretide API Price utilized in the formulation of products. Elamipretide API Price is not always fixed or binding as the Elamipretide Price is obtained through a variety of data sources. The Elamipretide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Elamipretide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elamipretide, including repackagers and relabelers. The FDA regulates Elamipretide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elamipretide API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Elamipretide supplier is an individual or a company that provides Elamipretide active pharmaceutical ingredient (API) or Elamipretide finished formulations upon request. The Elamipretide suppliers may include Elamipretide API manufacturers, exporters, distributors and traders.
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 Elamipretide as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Elamipretide 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 Elamipretide 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 Elamipretide and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Elamipretide NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Elamipretide suppliers with NDC on PharmaCompass.
Elamipretide 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 Elamipretide 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 Elamipretide GMP manufacturer or Elamipretide GMP API supplier for your needs.
A Elamipretide CoA (Certificate of Analysis) is a formal document that attests to Elamipretide's compliance with Elamipretide specifications and serves as a tool for batch-level quality control.
Elamipretide CoA mostly includes findings from lab analyses of a specific batch. For each Elamipretide 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.
Elamipretide may be tested according to a variety of international standards, such as European Pharmacopoeia (Elamipretide EP), Elamipretide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Elamipretide USP).