01 1Alps Pharmaceutical Co., Ltd.
01 1Azulene sodium sulfonate
01 1Japan
Registration Number : 217MF11057
Registrant's Address : 2-10-50 Mukaimachi, Furukawa-cho, Hida-shi, Gifu Prefecture
Initial Date of Registration : 2005-12-02
Latest Date of Registration : 2007-05-02
A Azulene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Azulene, including repackagers and relabelers. The FDA regulates Azulene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Azulene 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 Azulene supplier is an individual or a company that provides Azulene active pharmaceutical ingredient (API) or Azulene finished formulations upon request. The Azulene suppliers may include Azulene API manufacturers, exporters, distributors and traders.
click here to find a list of Azulene 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 Azulene Drug Master File in Japan (Azulene JDMF) empowers Azulene 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 Azulene JDMF during the approval evaluation for pharmaceutical products. At the time of Azulene 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 Azulene suppliers with JDMF on PharmaCompass.
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