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API SUPPLIERS
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ABOUT THIS PAGE
A Epalrestat manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Epalrestat, including repackagers and relabelers. The FDA regulates Epalrestat manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Epalrestat 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 Epalrestat manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Epalrestat supplier is an individual or a company that provides Epalrestat active pharmaceutical ingredient (API) or Epalrestat finished formulations upon request. The Epalrestat suppliers may include Epalrestat API manufacturers, exporters, distributors and traders.
click here to find a list of Epalrestat 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 Epalrestat Drug Master File in Japan (Epalrestat JDMF) empowers Epalrestat 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 Epalrestat JDMF during the approval evaluation for pharmaceutical products. At the time of Epalrestat 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 Epalrestat suppliers with JDMF on PharmaCompass.
A Epalrestat written confirmation (Epalrestat WC) is an official document issued by a regulatory agency to a Epalrestat manufacturer, verifying that the manufacturing facility of a Epalrestat active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Epalrestat APIs or Epalrestat finished pharmaceutical products to another nation, regulatory agencies frequently require a Epalrestat WC (written confirmation) as part of the regulatory process.
click here to find a list of Epalrestat suppliers with Written Confirmation (WC) on PharmaCompass.
Epalrestat 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 Epalrestat 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 Epalrestat GMP manufacturer or Epalrestat GMP API supplier for your needs.
A Epalrestat CoA (Certificate of Analysis) is a formal document that attests to Epalrestat's compliance with Epalrestat specifications and serves as a tool for batch-level quality control.
Epalrestat CoA mostly includes findings from lab analyses of a specific batch. For each Epalrestat 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.
Epalrestat may be tested according to a variety of international standards, such as European Pharmacopoeia (Epalrestat EP), Epalrestat JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Epalrestat USP).
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