01 1Assia Chemical Industries Ltd.
02 1FORMOSA LABORATORIES, INC.
03 1Nissan Chemical Corporation
04 1YS Life Science Co. , Ltd.
01 2Maxacalcitol
02 1Maxacalcitol "Teva"
03 1Maxacalcitol (for manufacturing only)
01 1Israel
02 1Japan
03 1South Korea
04 1Taiwan
Registration Number : 226MF10176
Registrant's Address : Neot-Hovav Eco-Industrial Park, Emek Sara P. O. Box 2049 Be'er Sheva 8412316, Israel
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2014-09-01
Registration Number : 226MF10138
Registrant's Address : 36 Hoping Street, Louchu, Taoyuan 33842, Taiwan
Initial Date of Registration : 2014-07-31
Latest Date of Registration : 2019-06-12
Registration Number : 226MF10174
Registrant's Address : 2-5-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2015-05-14
Maxacalcitol (for manufacturing only)
Registration Number : 306MF10021
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2024-02-07
Latest Date of Registration : 2024-09-03
A Maxacalcitol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maxacalcitol, including repackagers and relabelers. The FDA regulates Maxacalcitol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maxacalcitol 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 Maxacalcitol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Maxacalcitol supplier is an individual or a company that provides Maxacalcitol active pharmaceutical ingredient (API) or Maxacalcitol finished formulations upon request. The Maxacalcitol suppliers may include Maxacalcitol API manufacturers, exporters, distributors and traders.
click here to find a list of Maxacalcitol 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 Maxacalcitol Drug Master File in Japan (Maxacalcitol JDMF) empowers Maxacalcitol 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 Maxacalcitol JDMF during the approval evaluation for pharmaceutical products. At the time of Maxacalcitol 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 Maxacalcitol suppliers with JDMF on PharmaCompass.
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