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