01 1Kyowa Pharma Chemical Co., Ltd.
02 1Ouchi Shinko Chemical Industry Co., Ltd.
03 1Tateyama Chemical Co., Ltd.
01 1Istradefylline
02 1Istradefylline (manufacturing only)
03 1Istradefylline (production only)
01 3Japan
Istradefylline (for manufacturing purposes only)
Registration Number : 229MF10036
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2017-02-08
Latest Date of Registration : 2017-02-08
Istradefylline (for manufacturing purposes only)
Registration Number : 303MF10109
Registrant's Address : 7-4, Nihonbashi Kofunecho, Chuo-ku, Tokyo
Initial Date of Registration : 2021-07-16
Latest Date of Registration : 2022-05-12
Registration Number : 303MF10119
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2021-07-28
Latest Date of Registration : 2022-08-17
A Istradefylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Istradefylline, including repackagers and relabelers. The FDA regulates Istradefylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Istradefylline 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 Istradefylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Istradefylline supplier is an individual or a company that provides Istradefylline active pharmaceutical ingredient (API) or Istradefylline finished formulations upon request. The Istradefylline suppliers may include Istradefylline API manufacturers, exporters, distributors and traders.
click here to find a list of Istradefylline 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 Istradefylline Drug Master File in Japan (Istradefylline JDMF) empowers Istradefylline 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 Istradefylline JDMF during the approval evaluation for pharmaceutical products. At the time of Istradefylline 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 Istradefylline suppliers with JDMF on PharmaCompass.
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