01 1Daito Co., Ltd.
02 1Permakem Asia Co., Ltd.
03 1Shiratori Pharmaceutical Co., Ltd.
01 1Emme Das Chin fumarate
02 1Fumaric acid emedastine
03 1Japanese Pharmacopoeia fumaric acid emedastin production dedicated
01 3Japan
Registration Number : 228MF10218
Registrant's Address : 326 Yokamachi, Toyama City, Toyama Prefecture
Initial Date of Registration : 2016-11-15
Latest Date of Registration : 2017-10-03
Registration Number : 217MF11139
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2008-09-19
Japanese Pharmacopoeia Emedastine Fumarate For manufacturing only
Registration Number : 230MF10017
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2018-02-05
Latest Date of Registration : 2018-02-05
A Emedastine Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Emedastine Fumarate, including repackagers and relabelers. The FDA regulates Emedastine Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Emedastine Fumarate 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 Emedastine Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Emedastine Fumarate supplier is an individual or a company that provides Emedastine Fumarate active pharmaceutical ingredient (API) or Emedastine Fumarate finished formulations upon request. The Emedastine Fumarate suppliers may include Emedastine Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Emedastine Fumarate 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 Emedastine Fumarate Drug Master File in Japan (Emedastine Fumarate JDMF) empowers Emedastine Fumarate 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 Emedastine Fumarate JDMF during the approval evaluation for pharmaceutical products. At the time of Emedastine Fumarate 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 Emedastine Fumarate suppliers with JDMF on PharmaCompass.
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