01 1Daiichi Sankyo Propharma Co., Ltd.
02 1Takeda Pharmaceutical Company Limited
01 1Day stations dihydrocodeine phosphate (production only)
02 1Dihydrocodeine phosphate "Takeda"
01 2Japan
Japanese Pharmacopoeia Dihydrocodeine Phosphate (for manufacturing only)
Registration Number : 218MF11021
Registrant's Address : 3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2006-12-28
Latest Date of Registration : 2009-04-08
Dihydrocodeine phosphate "Takeda"
Registration Number : 219MF10064
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 4-1-1
Initial Date of Registration : 2007-03-05
Latest Date of Registration : 2019-07-26
A Codeine Phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Codeine Phosphate, including repackagers and relabelers. The FDA regulates Codeine Phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Codeine Phosphate 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 Codeine Phosphate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Codeine Phosphate supplier is an individual or a company that provides Codeine Phosphate active pharmaceutical ingredient (API) or Codeine Phosphate finished formulations upon request. The Codeine Phosphate suppliers may include Codeine Phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Codeine Phosphate 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 Codeine Phosphate Drug Master File in Japan (Codeine Phosphate JDMF) empowers Codeine Phosphate 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 Codeine Phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of Codeine Phosphate 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 Codeine Phosphate suppliers with JDMF on PharmaCompass.
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