01 2Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
02 1Procos S. p. A.
03 1Ryoto Fine Co., Ltd.
04 1Toray Industries, Inc.
05 1Yonsung Fine Chemicals Co. , Ltd.
01 1Nalfurafine Hydrochloride For Manufacturing
02 4Nalfurafine hydrochloride salt
03 1Nalfurafine hydrochloride salt production dedicated
01 1Italy
02 4Japan
03 1South Korea
Nalfurafine hydrochloride For manufacturing purposes only
Registration Number : 229MF10043
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2017-02-20
Latest Date of Registration : 2018-05-25
Nalfurafine hydrochloride For manufacturing purposes only
Registration Number : 305MF10059
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2023-05-10
Latest Date of Registration : 2023-05-10
Registration Number : 229MF10052
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2017-02-22
Latest Date of Registration : 2017-02-22
Registration Number : 229MF10018
Registrant's Address : 1410 Takada, Kashiwa City, Chiba Prefecture
Initial Date of Registration : 2017-01-25
Latest Date of Registration : 2017-01-25
Registration Number : 225MF10135
Registrant's Address : 2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2013-07-23
Latest Date of Registration : 2020-07-16
Registration Number : 229MF10038
Registrant's Address : 207, Sujeong-ro, Jangan-myeon, Hwaseong-si, Gyeonggi-do, 18581, Republic of Korea
Initial Date of Registration : 2017-02-13
Latest Date of Registration : 2019-10-18
A Nalfurafine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nalfurafine, including repackagers and relabelers. The FDA regulates Nalfurafine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nalfurafine 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 Nalfurafine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nalfurafine supplier is an individual or a company that provides Nalfurafine active pharmaceutical ingredient (API) or Nalfurafine finished formulations upon request. The Nalfurafine suppliers may include Nalfurafine API manufacturers, exporters, distributors and traders.
click here to find a list of Nalfurafine 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 Nalfurafine Drug Master File in Japan (Nalfurafine JDMF) empowers Nalfurafine 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 Nalfurafine JDMF during the approval evaluation for pharmaceutical products. At the time of Nalfurafine 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 Nalfurafine suppliers with JDMF on PharmaCompass.
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