01 1FORMOSA LABORATORIES, INC.
02 1MicroBiopharm Japan Co., Ltd.
03 1Shiono Finesse Co., Ltd.
01 2Calcitriol
02 1File Leka Rushito triol bulk powder
01 2Japan
02 1Taiwan
Registration Number : 228MF10187
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2016-09-26
Latest Date of Registration : 2016-09-26
Registration Number : 223MF10117
Registrant's Address : 1-3-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-07-25
Latest Date of Registration : 2014-03-11
Registration Number : 218MF10427
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 3-1-6
Initial Date of Registration : 2006-04-27
Latest Date of Registration : 2009-12-09
A Calcitriol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcitriol, including repackagers and relabelers. The FDA regulates Calcitriol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcitriol 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 Calcitriol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcitriol supplier is an individual or a company that provides Calcitriol active pharmaceutical ingredient (API) or Calcitriol finished formulations upon request. The Calcitriol suppliers may include Calcitriol API manufacturers, exporters, distributors and traders.
click here to find a list of Calcitriol 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 Calcitriol Drug Master File in Japan (Calcitriol JDMF) empowers Calcitriol 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 Calcitriol JDMF during the approval evaluation for pharmaceutical products. At the time of Calcitriol 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 Calcitriol suppliers with JDMF on PharmaCompass.
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