01 1Alps Pharmaceutical Co., Ltd.
01 1Japanese Pharmacopoeia quinine hydrochloride hydrate
01 1Japan
Japanese Pharmacopoeia Quinine Hydrochloride Hydrate
Registration Number : 222MF10105
Registrant's Address : 10-50, Mukai-cho 2-chome, Furukawa-cho, Hida City, Gifu Prefecture
Initial Date of Registration : 2010-03-19
Latest Date of Registration : 2010-03-19
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A Odan Brand of Quinine Sulfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Odan Brand of Quinine Sulfate, including repackagers and relabelers. The FDA regulates Odan Brand of Quinine Sulfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Odan Brand of Quinine Sulfate 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 Odan Brand of Quinine Sulfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Odan Brand of Quinine Sulfate supplier is an individual or a company that provides Odan Brand of Quinine Sulfate active pharmaceutical ingredient (API) or Odan Brand of Quinine Sulfate finished formulations upon request. The Odan Brand of Quinine Sulfate suppliers may include Odan Brand of Quinine Sulfate API manufacturers, exporters, distributors and traders.
click here to find a list of Odan Brand of Quinine Sulfate suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Odan Brand of Quinine Sulfate Drug Master File in Japan (Odan Brand of Quinine Sulfate JDMF) empowers Odan Brand of Quinine Sulfate 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 Odan Brand of Quinine Sulfate JDMF during the approval evaluation for pharmaceutical products. At the time of Odan Brand of Quinine Sulfate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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