01 1Daiichi Sankyo Co., Ltd.
02 1Takeda Pharmaceutical Company Limited
01 1Codeine acid hydrate "Takeda"
02 1Day stations codeine acid hydrate (production only)
01 2Japan
Japanese Pharmacopoeia 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 : 1-1 Doshomachi 4-chome, Chuo-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2006-07-20
Latest Date of Registration : 2020-04-17
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A CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)), including repackagers and relabelers. The FDA regulates CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) supplier is an individual or a company that provides CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) active pharmaceutical ingredient (API) or CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) finished formulations upon request. The CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) suppliers may include CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) API manufacturers, exporters, distributors and traders.
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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 (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) Drug Master File in Japan (CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) JDMF) empowers CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) 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 (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) JDMF during the approval evaluation for pharmaceutical products. At the time of CODEINE (SEE ALSO: CODEINE PHOSPHATE (CAS 52-28-8)) JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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