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