01 1Chemiclear Inc.
02 1DSM Nutritional Products Ltd.
03 2Nisshin Pharma Co., Ltd.
04 1Sanyo Fine Co., Ltd.
01 1Japanese Pharmacopoeia menatetrenone (production only)
02 1Japanese Pharmacopoeia phytonadione (production only)
03 1Phytonadione
04 1Phytonadione Phytonadione / Vitamin K1
05 1Vitamin K150% dispersion "Nissin"
01 1Gabon
02 3Japan
03 1Netherlands
Japanese Pharmacopoeia Menatetrenone (for manufacturing purposes only)
Registration Number : 217MF11147
Registrant's Address : Quattro Muromachi Building 9F, 4-1-6 Muromachi, Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2006-12-18
Registration Number : 217MF11107
Registrant's Address : 25 Kanda Nishikicho 1-chome, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2009-07-30
Registration Number : 217MF11106
Registrant's Address : 25 Kanda Nishikicho 1-chome, Chiyoda-ku, Tokyo
Initial Date of Registration : 2005-12-05
Latest Date of Registration : 2009-05-13
Registration Number : 218MF10101
Registrant's Address : Wurmisweg 576, CH-4303, Kaiseraugst, Switzerland
Initial Date of Registration : 2006-01-30
Latest Date of Registration : 2006-12-27
Japanese Pharmacopoeia Phytonadione (for manufacturing only)
Registration Number : 226MF10052
Registrant's Address : Osaka Prefecture, Osaka City, Nishi Ward, Awaza 1-12-18
Initial Date of Registration : 2014-03-06
Latest Date of Registration : 2014-03-06
A Vitamin K1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Vitamin K1, including repackagers and relabelers. The FDA regulates Vitamin K1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Vitamin K1 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 Vitamin K1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Vitamin K1 supplier is an individual or a company that provides Vitamin K1 active pharmaceutical ingredient (API) or Vitamin K1 finished formulations upon request. The Vitamin K1 suppliers may include Vitamin K1 API manufacturers, exporters, distributors and traders.
click here to find a list of Vitamin K1 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 Vitamin K1 Drug Master File in Japan (Vitamin K1 JDMF) empowers Vitamin K1 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 Vitamin K1 JDMF during the approval evaluation for pharmaceutical products. At the time of Vitamin K1 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 Vitamin K1 suppliers with JDMF on PharmaCompass.
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