01 1Daiichi Sankyo Propharma Co., Ltd.
01 1Oxycodone hydrochloride hydrate
01 1Japan
Oxycodone hydrochloride hydrate
Registration Number : 227MF10164
Registrant's Address : 3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2015-06-18
Latest Date of Registration : 2015-06-18
A Eukodal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eukodal, including repackagers and relabelers. The FDA regulates Eukodal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eukodal 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 Eukodal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eukodal supplier is an individual or a company that provides Eukodal active pharmaceutical ingredient (API) or Eukodal finished formulations upon request. The Eukodal suppliers may include Eukodal API manufacturers, exporters, distributors and traders.
click here to find a list of Eukodal 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 Eukodal Drug Master File in Japan (Eukodal JDMF) empowers Eukodal 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 Eukodal JDMF during the approval evaluation for pharmaceutical products. At the time of Eukodal 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 Eukodal suppliers with JDMF on PharmaCompass.
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