01 1Permakem Asia Co., Ltd.
02 1Sanwa Chemical Co., Ltd.
01 1Jimoruhoramin
02 1Jimoruhoramin (production only)
01 2Japan
Registration Number : 217MF10711
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2007-09-04
Dimorpholamine (for manufacturing purposes only)
Registration Number : 223MF10102
Registrant's Address : 24-8 Tamura 9-chome, Hiratsuka City, Kanagawa Prefecture
Initial Date of Registration : 2011-07-11
Latest Date of Registration : 2011-07-11
A Morpholine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Morpholine, including repackagers and relabelers. The FDA regulates Morpholine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Morpholine 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 Morpholine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Morpholine supplier is an individual or a company that provides Morpholine active pharmaceutical ingredient (API) or Morpholine finished formulations upon request. The Morpholine suppliers may include Morpholine API manufacturers, exporters, distributors and traders.
click here to find a list of Morpholine 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 Morpholine Drug Master File in Japan (Morpholine JDMF) empowers Morpholine 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 Morpholine JDMF during the approval evaluation for pharmaceutical products. At the time of Morpholine 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 Morpholine suppliers with JDMF on PharmaCompass.
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