01 1Nisshin Pharma Co., Ltd.
01 1Tokorechinato external preparation for production
01 1Japan
Tocopherol for the manufacture of topical preparations
Registration Number : 217MF11110
Registrant's Address : 25 Kanda Nishikicho 1-chome, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2009-08-31
A Tocoretinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tocoretinate, including repackagers and relabelers. The FDA regulates Tocoretinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tocoretinate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Tocoretinate supplier is an individual or a company that provides Tocoretinate active pharmaceutical ingredient (API) or Tocoretinate finished formulations upon request. The Tocoretinate suppliers may include Tocoretinate API manufacturers, exporters, distributors and traders.
click here to find a list of Tocoretinate 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 Tocoretinate Drug Master File in Japan (Tocoretinate JDMF) empowers Tocoretinate 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 Tocoretinate JDMF during the approval evaluation for pharmaceutical products. At the time of Tocoretinate 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 Tocoretinate suppliers with JDMF on PharmaCompass.
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