01 1Kyowa Pharma Chemical Co., Ltd.
02 2Permachem Asia Co., Ltd.
03 1Pharmacostech CO. ,LTD
04 1Shiratori Pharmaceutical Co., Ltd.
01 2Hydrochloric acid Pilsicainide
02 1Japanese Pharmacopoeia Pilsicainide Hydrochloride Hydrate (For manufacturing purposes only)
03 1Pilsicainide Hydrochloride Hydrate
04 1Pilsicainide hydrochloride hydrate
01 4Japan
02 1South Korea
Japanese Pharmacopoeia Pilsicainide Hydrochloride Hydrate (For Manufacturing Use Only)
Registration Number : 307MF10101
Registrant's Address : 530 Chokeiji, Takaoka City, Toyama Prefecture
Initial Date of Registration : 2025-08-06
Latest Date of Registration : 2025-08-06
Pilsicainide hydrochloride hydrate
Registration Number : 230MF10084
Registrant's Address : 1-10-11 Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2018-07-09
Latest Date of Registration : 2018-07-09
Pilsicainide hydrochloride hydrate
Registration Number : 217MF11137
Registrant's Address : 1-10-11 Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2006-12-18
Pilsicainide Hydrochloride Hydrate
Registration Number : 302MF10133
Registrant's Address : 47, Jeyakdanji-ro, Hyangnam-eup, Hwaseong-si, Gyeonggi-do, Republic of Korea
Initial Date of Registration : 2020-10-29
Latest Date of Registration : 2020-10-29
Registration Number : 217MF10321
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2005-07-14
Latest Date of Registration : 2008-03-14
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A 03C8I9296V manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 03C8I9296V, including repackagers and relabelers. The FDA regulates 03C8I9296V manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 03C8I9296V API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A 03C8I9296V supplier is an individual or a company that provides 03C8I9296V active pharmaceutical ingredient (API) or 03C8I9296V finished formulations upon request. The 03C8I9296V suppliers may include 03C8I9296V API manufacturers, exporters, distributors and traders.
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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 03C8I9296V Drug Master File in Japan (03C8I9296V JDMF) empowers 03C8I9296V 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 03C8I9296V JDMF during the approval evaluation for pharmaceutical products. At the time of 03C8I9296V 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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