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 Oxycodone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxycodone, including repackagers and relabelers. The FDA regulates Oxycodone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxycodone 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 Oxycodone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxycodone supplier is an individual or a company that provides Oxycodone active pharmaceutical ingredient (API) or Oxycodone finished formulations upon request. The Oxycodone suppliers may include Oxycodone API manufacturers, exporters, distributors and traders.
click here to find a list of Oxycodone 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 Oxycodone Drug Master File in Japan (Oxycodone JDMF) empowers Oxycodone 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 Oxycodone JDMF during the approval evaluation for pharmaceutical products. At the time of Oxycodone 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 Oxycodone suppliers with JDMF on PharmaCompass.
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