01 1DONGBANG FUTURE TECH & LIFE CO. , LTD.
02 1Kanto Chemical Co., Ltd.
01 1Irsogladine Maleate
02 1Maleic acid irsogladine - deer
01 1Japan
02 1South Korea
Registration Number : 306MF10156
Registrant's Address : 78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2024-12-11
Latest Date of Registration : 2024-12-11
Registration Number : 218MF10301
Registrant's Address : 3-2-8 Nihonbashi Honcho, Chuo-ku, Tokyo
Initial Date of Registration : 2006-02-28
Latest Date of Registration : 2019-10-25
A Irsogladine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Irsogladine Maleate, including repackagers and relabelers. The FDA regulates Irsogladine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Irsogladine Maleate 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 Irsogladine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Irsogladine Maleate supplier is an individual or a company that provides Irsogladine Maleate active pharmaceutical ingredient (API) or Irsogladine Maleate finished formulations upon request. The Irsogladine Maleate suppliers may include Irsogladine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Irsogladine Maleate 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 Irsogladine Maleate Drug Master File in Japan (Irsogladine Maleate JDMF) empowers Irsogladine Maleate 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 Irsogladine Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Irsogladine Maleate 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 Irsogladine Maleate suppliers with JDMF on PharmaCompass.
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