01 2Nippon Rika Pharmaceuticals Co., Ltd.
02 1Permakem Asia Co., Ltd.
03 1Sanyo Chemical Research Institute Co., Ltd.
01 2Ibudilast
02 1Japanese Pharmacopoeia ibudilast
03 1Outsider regulations ibudilast
01 1Gabon
02 3Japan
Japanese Pharmacopoeia Ibudilast
Registration Number : 219MF10339
Registrant's Address : 2-2 Nihonbashi Honcho 4-chome, Chuo-ku, Tokyo
Initial Date of Registration : 2007-11-21
Latest Date of Registration : 2007-11-21
External Regulations Ibudilast
Registration Number : 217MF10064
Registrant's Address : 4-2-2 Nihonbashi Honcho, Chuo Ward, Tokyo
Initial Date of Registration : 2005-05-20
Latest Date of Registration : 2006-03-09
Registration Number : 217MF10715
Registrant's Address : 1-10-11, Nihonbashi Horidomecho, Chuo-ku, Tokyo
Initial Date of Registration : 2005-10-07
Latest Date of Registration : 2008-12-22
Registration Number : 221MF10139
Registrant's Address : 148-1 Tajii, Mihara-ku, Sakai City, Osaka Prefecture
Initial Date of Registration : 2009-07-09
Latest Date of Registration : 2009-07-09
A Ibudilast manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ibudilast, including repackagers and relabelers. The FDA regulates Ibudilast manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ibudilast 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 Ibudilast manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ibudilast supplier is an individual or a company that provides Ibudilast active pharmaceutical ingredient (API) or Ibudilast finished formulations upon request. The Ibudilast suppliers may include Ibudilast API manufacturers, exporters, distributors and traders.
click here to find a list of Ibudilast 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 Ibudilast Drug Master File in Japan (Ibudilast JDMF) empowers Ibudilast 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 Ibudilast JDMF during the approval evaluation for pharmaceutical products. At the time of Ibudilast 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 Ibudilast suppliers with JDMF on PharmaCompass.
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