01 1Sankyo Kasei Co., Ltd.
01 1Outsider regulations hydrochloride para butyl aminobenzoate diethylaminoethyl(Production only)
01 1Japan
Diethylaminoethyl parabutylaminobenzoate hydrochloride (for manufacturing purposes only)
Registration Number : 220MF10139
Registrant's Address : 1-4-16 Dojimahama, Kita-ku, Osaka City, Osaka Prefecture
Initial Date of Registration : 2008-06-10
Latest Date of Registration : 2008-06-10
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PharmaCompass offers a list of Butamben API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Butamben manufacturer or Butamben supplier for your needs.
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A 06970_FLUKA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 06970_FLUKA, including repackagers and relabelers. The FDA regulates 06970_FLUKA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 06970_FLUKA 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 06970_FLUKA supplier is an individual or a company that provides 06970_FLUKA active pharmaceutical ingredient (API) or 06970_FLUKA finished formulations upon request. The 06970_FLUKA suppliers may include 06970_FLUKA 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 06970_FLUKA Drug Master File in Japan (06970_FLUKA JDMF) empowers 06970_FLUKA 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 06970_FLUKA JDMF during the approval evaluation for pharmaceutical products. At the time of 06970_FLUKA 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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