01 1Cambrex Karlskoga AB
02 1Eisai Co., Ltd.
03 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
04 1Rionlon (Tianjin) Pharmaceutical Co. , Ltd.
05 2Yoshindo Co., Ltd.
01 1Japanese Pharmacopoeia Teprenon
02 1Only the Japanese Pharmacopoeia teprenone production
03 1Teprenon-Rionlon
04 2Teprenone
05 1Teprenone (N)
01 1China
02 4Japan
03 1U.S.A
Registration Number : 218MF10987
Registrant's Address : SE-691 85 Karlskoga, SWEDEN
Initial Date of Registration : 2006-12-18
Latest Date of Registration : 2006-12-18
Japanese Pharmacopoeia Teprenone
Registration Number : 303MF10051
Registrant's Address : 4-6-10 Koishikawa, Bunkyo-ku, Tokyo
Initial Date of Registration : 2021-03-26
Latest Date of Registration : 2021-03-26
Japanese Pharmacopoeia Teprenone For manufacturing only
Registration Number : 222MF10245
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2010-10-21
Latest Date of Registration : 2021-06-15
Registration Number : 303MF10093
Registrant's Address : 4/F, Tower A, Wanshun Garden, No. 89 Huangpu Road, Hexi Area, Tianjin, China
Initial Date of Registration : 2021-06-09
Latest Date of Registration : 2021-06-09
Registration Number : 224MF10118
Registrant's Address : 3697-8 Hagishima, Funauchi-cho, Toyama City, Toyama Prefecture
Initial Date of Registration : 2012-07-04
Latest Date of Registration : 2014-05-14
Registration Number : 218MF10124
Registrant's Address : 3697-8 Hagishima, Funauchi-cho, Toyama City, Toyama Prefecture
Initial Date of Registration : 2006-01-30
Latest Date of Registration : 2007-09-06
A Teprenone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Teprenone, including repackagers and relabelers. The FDA regulates Teprenone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Teprenone 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 Teprenone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Teprenone supplier is an individual or a company that provides Teprenone active pharmaceutical ingredient (API) or Teprenone finished formulations upon request. The Teprenone suppliers may include Teprenone API manufacturers, exporters, distributors and traders.
click here to find a list of Teprenone 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 Teprenone Drug Master File in Japan (Teprenone JDMF) empowers Teprenone 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 Teprenone JDMF during the approval evaluation for pharmaceutical products. At the time of Teprenone 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 Teprenone suppliers with JDMF on PharmaCompass.
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