US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Cefixime API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Cefixime manufacturer or Cefixime supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Cefixime manufacturer or Cefixime supplier.
PharmaCompass also assists you with knowing the Cefixime API Price utilized in the formulation of products. Cefixime API Price is not always fixed or binding as the Cefixime Price is obtained through a variety of data sources. The Cefixime Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Cefixime manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cefixime, including repackagers and relabelers. The FDA regulates Cefixime manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cefixime 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 Cefixime manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cefixime supplier is an individual or a company that provides Cefixime active pharmaceutical ingredient (API) or Cefixime finished formulations upon request. The Cefixime suppliers may include Cefixime API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Cefixime 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 Cefixime Drug Master File in Japan (Cefixime JDMF) empowers Cefixime 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 Cefixime JDMF during the approval evaluation for pharmaceutical products. At the time of Cefixime 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 Cefixime suppliers with JDMF on PharmaCompass.