01 1Daiichi Sankyo Propharma Co., Ltd.
02 1Takeda Pharmaceutical Company Limited
01 1Codeine acid hydrate "Takeda"
02 1Day stations codeine acid hydrate (production only)
01 2Japan
JP Codeine Phosphate Hydrate (For manufacturing purposes only)
Registration Number : 219MF10035
Registrant's Address : 3-5-1 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2007-02-13
Latest Date of Registration : 2009-04-08
Codeine phosphate hydrate "Takeda"
Registration Number : 218MF10632
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 4-1-1
Initial Date of Registration : 2006-07-20
Latest Date of Registration : 2020-04-17
A Codeine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Codeine, including repackagers and relabelers. The FDA regulates Codeine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Codeine 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Codeine supplier is an individual or a company that provides Codeine active pharmaceutical ingredient (API) or Codeine finished formulations upon request. The Codeine suppliers may include Codeine API manufacturers, exporters, distributors and traders.
click here to find a list of Codeine 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 Drug Master File in Japan (Codeine JDMF) empowers Codeine 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Codeine 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 suppliers with JDMF on PharmaCompass.
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