01 1DONGBANG FUTURE TECH & LIFE CO. , LTD.
02 1Ryoto Fine Co., Ltd.
01 1Japanese Pharmacopoeia yl Seo Gras Jin maleate (manufactured only)
02 1Yl Seo Gras Gin maleate
01 1Japan
02 1South Korea
Registration Number : 225MF10087
Registrant's Address : 78, Jeyakgongdan 4-gil, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Korea
Initial Date of Registration : 2013-04-23
Latest Date of Registration : 2013-04-23
Japanese Pharmacopoeia Irsogladine Maleate (For manufacturing only)
Registration Number : 222MF10136
Registrant's Address : 1410 Takada, Kashiwa City, Chiba Prefecture
Initial Date of Registration : 2010-04-14
Latest Date of Registration : 2010-04-14
A Maleic Acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Maleic Acid, including repackagers and relabelers. The FDA regulates Maleic Acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Maleic Acid 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 Maleic Acid manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Maleic Acid supplier is an individual or a company that provides Maleic Acid active pharmaceutical ingredient (API) or Maleic Acid finished formulations upon request. The Maleic Acid suppliers may include Maleic Acid API manufacturers, exporters, distributors and traders.
click here to find a list of Maleic Acid 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 Maleic Acid Drug Master File in Japan (Maleic Acid JDMF) empowers Maleic Acid 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 Maleic Acid JDMF during the approval evaluation for pharmaceutical products. At the time of Maleic Acid 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 Maleic Acid suppliers with JDMF on PharmaCompass.
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