01 1Pharmacostech CO. ,LTD
02 1Yamasa Soy Sauce Co., Ltd.
01 1Day stations mizoribine (production only)
02 1Mizoribine
01 1Japan
02 1South Korea
Registration Number : 221MF10012
Registrant's Address : 47, Jeyakdanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Republic of Korea
Initial Date of Registration : 2009-01-13
Latest Date of Registration : 2009-07-21
JP Mizoribine (for manufacturing only)
Registration Number : 221MF10052
Registrant's Address : 2-10-1 Shinseicho, Choshi City, Chiba Prefecture
Initial Date of Registration : 2009-03-16
Latest Date of Registration : 2009-03-16
A Mizoribine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mizoribine, including repackagers and relabelers. The FDA regulates Mizoribine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mizoribine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Mizoribine supplier is an individual or a company that provides Mizoribine active pharmaceutical ingredient (API) or Mizoribine finished formulations upon request. The Mizoribine suppliers may include Mizoribine API manufacturers, exporters, distributors and traders.
click here to find a list of Mizoribine 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 Mizoribine Drug Master File in Japan (Mizoribine JDMF) empowers Mizoribine 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 Mizoribine JDMF during the approval evaluation for pharmaceutical products. At the time of Mizoribine 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 Mizoribine suppliers with JDMF on PharmaCompass.
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