01 1FORMOSA LABORATORIES, INC.
02 1Nisshin Pharma Co., Ltd.
03 1Ryoto Fine Co., Ltd.
04 1Teijin Pharma Limited
01 1Alfacalcidol
02 1Alfacalcidol "Nissin"
03 1Alfacalcidol (production only)
04 1One-alpha
01 3Japan
02 1Taiwan
Registration Number : 302MF10045
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2020-04-14
Latest Date of Registration : 2020-04-14
Registration Number : 217MF11108
Registrant's Address : 25 Kanda Nishikicho 1-chome, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2006-11-06
Alfacalcidol (for manufacturing only)
Registration Number : 222MF10194
Registrant's Address : 1410 Takada, Kashiwa City, Chiba Prefecture
Initial Date of Registration : 2010-07-09
Latest Date of Registration : 2021-01-20
Registration Number : 218MF10176
Registrant's Address : 2-1 Kasumigaseki 3-chome, Chiyoda-ku, Tokyo
Initial Date of Registration : 2006-02-08
Latest Date of Registration : 2010-03-09
A Alfacalcidol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alfacalcidol, including repackagers and relabelers. The FDA regulates Alfacalcidol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alfacalcidol 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 Alfacalcidol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alfacalcidol supplier is an individual or a company that provides Alfacalcidol active pharmaceutical ingredient (API) or Alfacalcidol finished formulations upon request. The Alfacalcidol suppliers may include Alfacalcidol API manufacturers, exporters, distributors and traders.
click here to find a list of Alfacalcidol 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 Alfacalcidol Drug Master File in Japan (Alfacalcidol JDMF) empowers Alfacalcidol 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 Alfacalcidol JDMF during the approval evaluation for pharmaceutical products. At the time of Alfacalcidol 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 Alfacalcidol suppliers with JDMF on PharmaCompass.
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