01 1Japan Household Salt Co., Ltd.
02 2Macco Organiques, s. r. o.
03 1Manac Corporation
04 2Tomita Pharmaceutical Co., Ltd.
05 1Uji Pharmaceutical Co., Ltd.
01 1Japanese Pharmacopoeia Drug potassium chloride (production only)
02 1Japanese Pharmacopoeia Potassium Chloride
03 2Japanese Pharmacopoeia potassium chloride (production only)
04 1Potassium Chloride
05 2Potassium chloride
01 2Czech Republic
02 1Gabon
03 4Japan
Registration Number : 306MF10055
Registrant's Address : Zahradni(') 46c,792 01 Brunta(')l, Czech Republic
Initial Date of Registration : 2024-04-10
Latest Date of Registration : 2024-04-10
Registration Number : 227MF10169
Registrant's Address : Zahradni(') 46c,792 01 Brunta(')l, Czech Republic
Initial Date of Registration : 2015-06-18
Latest Date of Registration : 2015-06-18
Japanese Pharmacopoeia Potassium Chloride (for manufacturing only)
Registration Number : 217MF10675
Registrant's Address : 92 Minookicho, Fukuyama City, Hiroshima Prefecture
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2006-09-22
Registration Number : 217MF10517
Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1
Initial Date of Registration : 2005-09-07
Latest Date of Registration : 2006-10-20
Japanese Pharmacopoeia Potassium Chloride
Registration Number : 301MF10006
Registrant's Address : Tokushima Prefecture Naruto City Setocho Myojin Maruyama 85-1
Initial Date of Registration : 2019-05-27
Latest Date of Registration : 2019-05-27
Japanese Pharmacopoeia Potassium Chloride (for manufacturing only)
Registration Number : 217MF10592
Registrant's Address : 7 Kamihonjo, Myojin, Seto-cho, Naruto City, Tokushima Prefecture
Initial Date of Registration : 2005-09-14
Latest Date of Registration : 2006-12-27
Japanese Pharmacopoeia Potassium Chloride (for manufacturing only)
Registration Number : 221MF10101
Registrant's Address : 2471 Munekami, Tamano City, Okayama Prefecture
Initial Date of Registration : 2009-05-27
Latest Date of Registration : 2009-05-27
A K-Dur manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of K-Dur, including repackagers and relabelers. The FDA regulates K-Dur manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. K-Dur 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 K-Dur manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A K-Dur supplier is an individual or a company that provides K-Dur active pharmaceutical ingredient (API) or K-Dur finished formulations upon request. The K-Dur suppliers may include K-Dur API manufacturers, exporters, distributors and traders.
click here to find a list of K-Dur 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 K-Dur Drug Master File in Japan (K-Dur JDMF) empowers K-Dur 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 K-Dur JDMF during the approval evaluation for pharmaceutical products. At the time of K-Dur 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 K-Dur suppliers with JDMF on PharmaCompass.
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