01 1Sekisui Medical Co., Ltd.
01 1Clemastine fumarate
01 1Japan
Registration Number : 219MF10016
Registrant's Address : 3-13-5 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2007-01-18
Latest Date of Registration : 2007-01-18
A Clemastine Fumarate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clemastine Fumarate, including repackagers and relabelers. The FDA regulates Clemastine Fumarate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clemastine 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 Clemastine Fumarate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Clemastine Fumarate supplier is an individual or a company that provides Clemastine Fumarate active pharmaceutical ingredient (API) or Clemastine Fumarate finished formulations upon request. The Clemastine Fumarate suppliers may include Clemastine Fumarate API manufacturers, exporters, distributors and traders.
click here to find a list of Clemastine 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 Clemastine Fumarate Drug Master File in Japan (Clemastine Fumarate JDMF) empowers Clemastine 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 Clemastine Fumarate JDMF during the approval evaluation for pharmaceutical products. At the time of Clemastine 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 Clemastine Fumarate suppliers with JDMF on PharmaCompass.
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