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API SUPPLIERS
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JDMF
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Mesochem is focused on incessant innovation along with the R&D of new APIs.
About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...
Shanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.
About the Company : Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...
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ABOUT THIS PAGE
A Cetuximab manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cetuximab, including repackagers and relabelers. The FDA regulates Cetuximab manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cetuximab 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 Cetuximab manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cetuximab supplier is an individual or a company that provides Cetuximab active pharmaceutical ingredient (API) or Cetuximab finished formulations upon request. The Cetuximab suppliers may include Cetuximab API manufacturers, exporters, distributors and traders.
click here to find a list of Cetuximab 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 Cetuximab Drug Master File in Japan (Cetuximab JDMF) empowers Cetuximab 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 Cetuximab JDMF during the approval evaluation for pharmaceutical products. At the time of Cetuximab 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 Cetuximab suppliers with JDMF on PharmaCompass.
Cetuximab 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 Cetuximab 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 Cetuximab GMP manufacturer or Cetuximab GMP API supplier for your needs.
A Cetuximab CoA (Certificate of Analysis) is a formal document that attests to Cetuximab's compliance with Cetuximab specifications and serves as a tool for batch-level quality control.
Cetuximab CoA mostly includes findings from lab analyses of a specific batch. For each Cetuximab 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.
Cetuximab may be tested according to a variety of international standards, such as European Pharmacopoeia (Cetuximab EP), Cetuximab JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Cetuximab USP).
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