01 1Sankyo Kasei Co., Ltd.
01 1Outsider regulations hydrochloride para butyl aminobenzoate diethylaminoethyl(Production only)
01 1Japan
Registration Number : 220MF10139
Registrant's Address : Osaka Prefecture, Osaka City, Kita Ward, Dojimahama 1-4-16
Initial Date of Registration : 2008-06-10
Latest Date of Registration : 2008-06-10
A Butamben manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Butamben, including repackagers and relabelers. The FDA regulates Butamben manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Butamben 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 Butamben manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Butamben supplier is an individual or a company that provides Butamben active pharmaceutical ingredient (API) or Butamben finished formulations upon request. The Butamben suppliers may include Butamben API manufacturers, exporters, distributors and traders.
click here to find a list of Butamben 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 Butamben Drug Master File in Japan (Butamben JDMF) empowers Butamben 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 Butamben JDMF during the approval evaluation for pharmaceutical products. At the time of Butamben 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 Butamben suppliers with JDMF on PharmaCompass.
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