01 1Nagaoka Jitsugyo Co., Ltd.
02 1Ogi Pharmaceutical Co., Ltd.
03 1Symrise AG
04 1Takasago International Corporation
05 2Toyo Mint Industry Co., Ltd.
01 2Japanese Pharmacopoeia l- menthol (production only)
02 1Menthol JP
03 2l- menthol
04 1l- menthol SL-21
01 1Germany
02 5Japan
Japanese Pharmacopoeia l-Menthol (for manufacturing only)
Registration Number : 218MF10275
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 2-5-8
Initial Date of Registration : 2006-02-23
Latest Date of Registration : 2006-02-23
Japanese Pharmacopoeia l-Menthol (for manufacturing only)
Registration Number : 217MF10801
Registrant's Address : Hyogo Prefecture Nishinomiya City Nishinomiyahama 4-7-18
Initial Date of Registration : 2005-11-01
Latest Date of Registration : 2006-11-15
Registration Number : 218MF10705
Registrant's Address : Muehlenfeldstrasse 1 D-37 603 Holzminden Germany
Initial Date of Registration : 2006-08-11
Latest Date of Registration : 2013-05-09
Registration Number : 217MF11171
Registrant's Address : 5-37-1 Kamata, Ota-ku, Tokyo
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2010-04-01
Registration Number : 217MF10175
Registrant's Address : 75-1 Hamanaka, Satosho-cho, Asakuchi-gun, Okayama Prefecture
Initial Date of Registration : 2005-05-31
Latest Date of Registration : 2006-11-15
Registration Number : 217MF10179
Registrant's Address : 75-1 Hamanaka, Satosho-cho, Asakuchi-gun, Okayama Prefecture
Initial Date of Registration : 2005-05-31
Latest Date of Registration : 2007-03-14
A CAS-2216-51-5 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CAS-2216-51-5, including repackagers and relabelers. The FDA regulates CAS-2216-51-5 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CAS-2216-51-5 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 CAS-2216-51-5 supplier is an individual or a company that provides CAS-2216-51-5 active pharmaceutical ingredient (API) or CAS-2216-51-5 finished formulations upon request. The CAS-2216-51-5 suppliers may include CAS-2216-51-5 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 CAS-2216-51-5 Drug Master File in Japan (CAS-2216-51-5 JDMF) empowers CAS-2216-51-5 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 CAS-2216-51-5 JDMF during the approval evaluation for pharmaceutical products. At the time of CAS-2216-51-5 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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