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05 Jul 2016
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ABOUT THIS PAGE
A Eudragits manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eudragits, including repackagers and relabelers. The FDA regulates Eudragits manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eudragits 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 Eudragits supplier is an individual or a company that provides Eudragits active pharmaceutical ingredient (API) or Eudragits finished formulations upon request. The Eudragits suppliers may include Eudragits API manufacturers, exporters, distributors and traders.
Eudragits 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 Eudragits 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 Eudragits GMP manufacturer or Eudragits GMP API supplier for your needs.
A Eudragits CoA (Certificate of Analysis) is a formal document that attests to Eudragits's compliance with Eudragits specifications and serves as a tool for batch-level quality control.
Eudragits CoA mostly includes findings from lab analyses of a specific batch. For each Eudragits 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.
Eudragits may be tested according to a variety of international standards, such as European Pharmacopoeia (Eudragits EP), Eudragits JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Eudragits USP).
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