01 1Shanghai Wonder Pharmaceutical Co. , Ltd.
02 1Shizuoka Caffeine Industry Co., Ltd.
01 1Diprophylline (production only)
02 1Japanese Pharmacopoeia Non-Pharmaceutical Standard Dyphylline (for manufacturing only)
01 1China
02 1Japan
Diprophylline (for manufacturing only)
Registration Number : 217MF10611
Registrant's Address : 129 Suidocho, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2023-12-22
Japanese Pharmacopoeia Non-Drug Standard Diprophylline (For manufacturing only)
Registration Number : 301MF10018
Registrant's Address : No. 298, Huachuang Road, Jinshan District, Shanghai, P. R. China
Initial Date of Registration : 2019-06-07
Latest Date of Registration : 2019-06-07
A Dyphylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dyphylline, including repackagers and relabelers. The FDA regulates Dyphylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dyphylline 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 Dyphylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Dyphylline supplier is an individual or a company that provides Dyphylline active pharmaceutical ingredient (API) or Dyphylline finished formulations upon request. The Dyphylline suppliers may include Dyphylline API manufacturers, exporters, distributors and traders.
click here to find a list of Dyphylline 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 Dyphylline Drug Master File in Japan (Dyphylline JDMF) empowers Dyphylline 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 Dyphylline JDMF during the approval evaluation for pharmaceutical products. At the time of Dyphylline 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 Dyphylline suppliers with JDMF on PharmaCompass.
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