01 1Hamari PFST Co., Ltd.
02 1Yamamoto Chemical Industry Co., Ltd.
01 1Buformin hydrochloride "hamari Y"
02 1Japanese Pharmacopoeia buformin hydrochloride
01 2Japan
Japanese Pharmacopoeia Buformin Hydrochloride
Registration Number : 220MF10168
Registrant's Address : 1-4 Funatsucho, Wakayama City, Wakayama Prefecture
Initial Date of Registration : 2008-07-24
Latest Date of Registration : 2008-07-24
Buformin hydrochloride "Hamari Y"
Registration Number : 222MF10139
Registrant's Address : Osaka Prefecture, Osaka City, Suminoe Ward, Nanko Kita 1-19-40
Initial Date of Registration : 2010-04-14
Latest Date of Registration : 2010-04-14
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A 1190-53-0 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 1190-53-0, including repackagers and relabelers. The FDA regulates 1190-53-0 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 1190-53-0 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 1190-53-0 supplier is an individual or a company that provides 1190-53-0 active pharmaceutical ingredient (API) or 1190-53-0 finished formulations upon request. The 1190-53-0 suppliers may include 1190-53-0 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 1190-53-0 Drug Master File in Japan (1190-53-0 JDMF) empowers 1190-53-0 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 1190-53-0 JDMF during the approval evaluation for pharmaceutical products. At the time of 1190-53-0 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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