01 2Nissan Chemical Corporation
02 1Yonsung Fine Chemicals Co. , Ltd.
01 2Eldecalcitol
02 1Eldecalcitol FA
01 2Japan
02 1South Korea
Registration Number : 303MF10025
Registrant's Address : 2-5-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2021-02-05
Latest Date of Registration : 2021-02-05
Registration Number : 230MF10152
Registrant's Address : 2-5-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2018-11-14
Latest Date of Registration : 2018-11-14
Registration Number : 231MF10052
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2019-02-21
Latest Date of Registration : 2019-02-21
A Eldecalcitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Eldecalcitol, including repackagers and relabelers. The FDA regulates Eldecalcitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Eldecalcitol 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 Eldecalcitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Eldecalcitol supplier is an individual or a company that provides Eldecalcitol active pharmaceutical ingredient (API) or Eldecalcitol finished formulations upon request. The Eldecalcitol suppliers may include Eldecalcitol API manufacturers, exporters, distributors and traders.
click here to find a list of Eldecalcitol 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 Eldecalcitol Drug Master File in Japan (Eldecalcitol JDMF) empowers Eldecalcitol 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 Eldecalcitol JDMF during the approval evaluation for pharmaceutical products. At the time of Eldecalcitol 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 Eldecalcitol suppliers with JDMF on PharmaCompass.
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