01 1Konan Chemical Co., Ltd.
01 1Outsider regulations azulene sodium sulfonate (manufactured only)
01 1Japan
Sodium azulene sulfonate (for manufacturing only)
Registration Number : 218MF10123
Registrant's Address : 5-21 Nakagawacho, Takatsuki City, Osaka Prefecture
Initial Date of Registration : 2006-01-30
Latest Date of Registration : 2007-05-15
A Guazilene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Guazilene, including repackagers and relabelers. The FDA regulates Guazilene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Guazilene 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 Guazilene supplier is an individual or a company that provides Guazilene active pharmaceutical ingredient (API) or Guazilene finished formulations upon request. The Guazilene suppliers may include Guazilene API manufacturers, exporters, distributors and traders.
click here to find a list of Guazilene 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 Guazilene Drug Master File in Japan (Guazilene JDMF) empowers Guazilene 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 Guazilene JDMF during the approval evaluation for pharmaceutical products. At the time of Guazilene 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 Guazilene suppliers with JDMF on PharmaCompass.
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