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10 Feb 2022
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ABOUT THIS PAGE
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PharmaCompass offers a list of Sulbutiamine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Sulbutiamine manufacturer or Sulbutiamine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Sulbutiamine manufacturer or Sulbutiamine supplier.
A Enerion manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Enerion, including repackagers and relabelers. The FDA regulates Enerion manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Enerion 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 Enerion supplier is an individual or a company that provides Enerion active pharmaceutical ingredient (API) or Enerion finished formulations upon request. The Enerion suppliers may include Enerion API manufacturers, exporters, distributors and traders.
click here to find a list of Enerion suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Enerion Drug Master File in Japan (Enerion JDMF) empowers Enerion 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 Enerion JDMF during the approval evaluation for pharmaceutical products. At the time of Enerion 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 Enerion suppliers with JDMF on PharmaCompass.
Enerion 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 Enerion GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Enerion GMP manufacturer or Enerion GMP API supplier for your needs.
A Enerion CoA (Certificate of Analysis) is a formal document that attests to Enerion's compliance with Enerion specifications and serves as a tool for batch-level quality control.
Enerion CoA mostly includes findings from lab analyses of a specific batch. For each Enerion 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.
Enerion may be tested according to a variety of international standards, such as European Pharmacopoeia (Enerion EP), Enerion JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Enerion USP).
Comment (10)
