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01 1FORMOSA LABORATORIES, INC.
02 1Nisshin Pharma Co., Ltd.
03 1Ryoto Fine Co., Ltd.
04 1Teijin Pharma Limited
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01 1Alfacalcidol
02 1Alfacalcidol "Nissin"
03 1Alfacalcidol (production only)
04 1One-alpha
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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
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PharmaCompass offers a list of Alfacalcidol API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Alfacalcidol manufacturer or Alfacalcidol supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Alfacalcidol manufacturer or Alfacalcidol supplier.
PharmaCompass also assists you with knowing the Alfacalcidol API Price utilized in the formulation of products. Alfacalcidol API Price is not always fixed or binding as the Alfacalcidol Price is obtained through a variety of data sources. The Alfacalcidol Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Etalpha manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etalpha, including repackagers and relabelers. The FDA regulates Etalpha manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etalpha 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 Etalpha manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etalpha supplier is an individual or a company that provides Etalpha active pharmaceutical ingredient (API) or Etalpha finished formulations upon request. The Etalpha suppliers may include Etalpha API manufacturers, exporters, distributors and traders.
click here to find a list of Etalpha 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 Etalpha Drug Master File in Japan (Etalpha JDMF) empowers Etalpha 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 Etalpha JDMF during the approval evaluation for pharmaceutical products. At the time of Etalpha 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 Etalpha suppliers with JDMF on PharmaCompass.
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