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USDMF
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API SUPPLIERS
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INTERMEDIATES SUPPLIERS
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Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A Etilefrine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etilefrine, including repackagers and relabelers. The FDA regulates Etilefrine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etilefrine 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 Etilefrine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etilefrine supplier is an individual or a company that provides Etilefrine active pharmaceutical ingredient (API) or Etilefrine finished formulations upon request. The Etilefrine suppliers may include Etilefrine API manufacturers, exporters, distributors and traders.
click here to find a list of Etilefrine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Etilefrine Drug Master File in Japan (Etilefrine JDMF) empowers Etilefrine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Etilefrine JDMF during the approval evaluation for pharmaceutical products. At the time of Etilefrine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Etilefrine suppliers with JDMF on PharmaCompass.
A Etilefrine CEP of the European Pharmacopoeia monograph is often referred to as a Etilefrine Certificate of Suitability (COS). The purpose of a Etilefrine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Etilefrine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Etilefrine to their clients by showing that a Etilefrine CEP has been issued for it. The manufacturer submits a Etilefrine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Etilefrine CEP holder for the record. Additionally, the data presented in the Etilefrine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Etilefrine DMF.
A Etilefrine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Etilefrine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Etilefrine suppliers with CEP (COS) on PharmaCompass.
Etilefrine 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 Etilefrine 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 Etilefrine GMP manufacturer or Etilefrine GMP API supplier for your needs.
A Etilefrine CoA (Certificate of Analysis) is a formal document that attests to Etilefrine's compliance with Etilefrine specifications and serves as a tool for batch-level quality control.
Etilefrine CoA mostly includes findings from lab analyses of a specific batch. For each Etilefrine 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.
Etilefrine may be tested according to a variety of international standards, such as European Pharmacopoeia (Etilefrine EP), Etilefrine JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Etilefrine USP).
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