01 1Nagaoka Jitsugyo Co., Ltd.
02 1Suzuki Mint Co., Ltd.
03 3Toyo Mint Industry Co., Ltd.
01 1Japanese Pharmacopoeia peppermint oil (production only)
02 1Peppermint oil
03 1Peppermint oil (terpene-less SE)
04 1Peppermint oil T-10
05 1Peppermint white oil
01 5Japan
Japanese Pharmacopoeia Peppermint Oil (for manufacturing only)
Registration Number : 217MF10800
Registrant's Address : Hyogo Prefecture Nishinomiya City Nishinomiyahama 4-7-18
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2010-03-19
Registration Number : 218MF10571
Registrant's Address : Hyogo Prefecture Kobe City Chuo Ward Minatojima Minamimachi 3-2-12
Initial Date of Registration : 2006-06-15
Latest Date of Registration : 2006-06-15
Peppermint oil (terpene-less SE)
Registration Number : 217MF10177
Registrant's Address : 75-1 Hamanaka, Satosho-cho, Asakuchi-gun, Okayama Prefecture
Initial Date of Registration : 2005-05-31
Latest Date of Registration : 2009-10-26
Registration Number : 217MF10176
Registrant's Address : 75-1 Hamanaka, Satosho-cho, Asakuchi-gun, Okayama Prefecture
Initial Date of Registration : 2005-05-31
Latest Date of Registration : 2009-10-26
Registration Number : 226MF10160
Registrant's Address : 75-1 Hamanaka, Satosho-cho, Asakuchi-gun, Okayama Prefecture
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2015-08-11
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A Mentha Piperita Oil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mentha Piperita Oil, including repackagers and relabelers. The FDA regulates Mentha Piperita Oil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mentha Piperita Oil API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Mentha Piperita Oil supplier is an individual or a company that provides Mentha Piperita Oil active pharmaceutical ingredient (API) or Mentha Piperita Oil finished formulations upon request. The Mentha Piperita Oil suppliers may include Mentha Piperita Oil 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 Mentha Piperita Oil Drug Master File in Japan (Mentha Piperita Oil JDMF) empowers Mentha Piperita Oil 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 Mentha Piperita Oil JDMF during the approval evaluation for pharmaceutical products. At the time of Mentha Piperita Oil 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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