01 1Alfresa Fine Chemicals Co., Ltd.
01 1Pantethine
01 1Japan
Registration Number : 217MF10955
Registrant's Address : 1-10-1 Mukaihama, Akita City, Akita Prefecture
Initial Date of Registration : 2005-11-14
Latest Date of Registration : 2007-04-27
A Pantethine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pantethine, including repackagers and relabelers. The FDA regulates Pantethine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pantethine 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 Pantethine supplier is an individual or a company that provides Pantethine active pharmaceutical ingredient (API) or Pantethine finished formulations upon request. The Pantethine suppliers may include Pantethine API manufacturers, exporters, distributors and traders.
click here to find a list of Pantethine 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 Pantethine Drug Master File in Japan (Pantethine JDMF) empowers Pantethine 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 Pantethine JDMF during the approval evaluation for pharmaceutical products. At the time of Pantethine 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 Pantethine suppliers with JDMF on PharmaCompass.
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