01 1Ishihara Sangyo Kaisha, Ltd.
01 1Cevimeline (ISK)
01 1Japan
Cevimeline hydrochloride (ISK)
Registration Number : 218MF10409
Registrant's Address : 1-3-15 Edobori, Nishi-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2006-04-14
Latest Date of Registration : 2006-04-14
A Cevimeline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cevimeline, including repackagers and relabelers. The FDA regulates Cevimeline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cevimeline 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 Cevimeline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cevimeline supplier is an individual or a company that provides Cevimeline active pharmaceutical ingredient (API) or Cevimeline finished formulations upon request. The Cevimeline suppliers may include Cevimeline API manufacturers, exporters, distributors and traders.
click here to find a list of Cevimeline 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 Cevimeline Drug Master File in Japan (Cevimeline JDMF) empowers Cevimeline 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 Cevimeline JDMF during the approval evaluation for pharmaceutical products. At the time of Cevimeline 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 Cevimeline suppliers with JDMF on PharmaCompass.
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