01 1INIST ST CO. , LTD.
02 1Kaken Pharmaceutical Co., Ltd.
03 2Permakem Asia Co., Ltd.
01 1BUTENAFINE HYDROCHLORIDE
02 1Butenafine Hydrochloride
03 2Hydrochloric acid butenafine
01 3Japan
02 1South Korea
Registration Number : 221MF10212
Registrant's Address : 500, Sinnae-ro, Geumwang-eup, Eumseong-gun, Chungcheongbuk-do, Korea
Initial Date of Registration : 2009-09-28
Latest Date of Registration : 2009-09-28
Registration Number : 217MF10389
Registrant's Address : 2-28-8 Honkomagome, Bunkyo-ku, Tokyo
Initial Date of Registration : 2005-07-27
Latest Date of Registration : 2010-03-09
Registration Number : 301MF10044
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2019-08-09
Latest Date of Registration : 2019-08-09
Registration Number : 217MF11142
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2008-09-09
A Butenafine (Hydrochloride) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butenafine (Hydrochloride), including repackagers and relabelers. The FDA regulates Butenafine (Hydrochloride) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butenafine (Hydrochloride) 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 Butenafine (Hydrochloride) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Butenafine (Hydrochloride) supplier is an individual or a company that provides Butenafine (Hydrochloride) active pharmaceutical ingredient (API) or Butenafine (Hydrochloride) finished formulations upon request. The Butenafine (Hydrochloride) suppliers may include Butenafine (Hydrochloride) API manufacturers, exporters, distributors and traders.
click here to find a list of Butenafine (Hydrochloride) 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 Butenafine (Hydrochloride) Drug Master File in Japan (Butenafine (Hydrochloride) JDMF) empowers Butenafine (Hydrochloride) 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 Butenafine (Hydrochloride) JDMF during the approval evaluation for pharmaceutical products. At the time of Butenafine (Hydrochloride) 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 Butenafine (Hydrochloride) suppliers with JDMF on PharmaCompass.
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