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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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CEP/COS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 1998-088 - Rev 00
Status : Withdrawn by Holder
Issue Date : 2004-12-07
Type : Chemical
Substance Number : 636
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ABOUT THIS PAGE
A Propyphenazone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Propyphenazone, including repackagers and relabelers. The FDA regulates Propyphenazone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Propyphenazone 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 Propyphenazone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Propyphenazone supplier is an individual or a company that provides Propyphenazone active pharmaceutical ingredient (API) or Propyphenazone finished formulations upon request. The Propyphenazone suppliers may include Propyphenazone API manufacturers, exporters, distributors and traders.
click here to find a list of Propyphenazone 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 Propyphenazone Drug Master File in Japan (Propyphenazone JDMF) empowers Propyphenazone 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 Propyphenazone JDMF during the approval evaluation for pharmaceutical products. At the time of Propyphenazone 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 Propyphenazone suppliers with JDMF on PharmaCompass.
A Propyphenazone CEP of the European Pharmacopoeia monograph is often referred to as a Propyphenazone Certificate of Suitability (COS). The purpose of a Propyphenazone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Propyphenazone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Propyphenazone to their clients by showing that a Propyphenazone CEP has been issued for it. The manufacturer submits a Propyphenazone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Propyphenazone CEP holder for the record. Additionally, the data presented in the Propyphenazone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Propyphenazone DMF.
A Propyphenazone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Propyphenazone 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 Propyphenazone suppliers with CEP (COS) on PharmaCompass.
A Propyphenazone written confirmation (Propyphenazone WC) is an official document issued by a regulatory agency to a Propyphenazone manufacturer, verifying that the manufacturing facility of a Propyphenazone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Propyphenazone APIs or Propyphenazone finished pharmaceutical products to another nation, regulatory agencies frequently require a Propyphenazone WC (written confirmation) as part of the regulatory process.
click here to find a list of Propyphenazone suppliers with Written Confirmation (WC) on PharmaCompass.
Propyphenazone 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 Propyphenazone 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 Propyphenazone GMP manufacturer or Propyphenazone GMP API supplier for your needs.
A Propyphenazone CoA (Certificate of Analysis) is a formal document that attests to Propyphenazone's compliance with Propyphenazone specifications and serves as a tool for batch-level quality control.
Propyphenazone CoA mostly includes findings from lab analyses of a specific batch. For each Propyphenazone 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.
Propyphenazone may be tested according to a variety of international standards, such as European Pharmacopoeia (Propyphenazone EP), Propyphenazone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Propyphenazone USP).
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