01 1DYNAMIT NOBEL GmbH
02 1Toyo Pharmaceutical Co., Ltd.
01 140% mandelic nitrile ethanol solution
02 15% nitroglycerin-ethanol solution
01 1Germany
02 1Japan
Registration Number : 218MF10624
Registrant's Address : Kalkstrasse 218, 51377 Leverkusen, Germany
Initial Date of Registration : 2006-07-20
Latest Date of Registration : 2020-12-15
40% Mandelnitrile Ethanol Solution
Registration Number : 218MF10694
Registrant's Address : Osaka Prefecture, Osaka City, Chuo Ward, Doshomachi 2-1-5
Initial Date of Registration : 2006-08-11
Latest Date of Registration : 2006-08-11
A Ethanol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethanol, including repackagers and relabelers. The FDA regulates Ethanol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethanol 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 Ethanol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ethanol supplier is an individual or a company that provides Ethanol active pharmaceutical ingredient (API) or Ethanol finished formulations upon request. The Ethanol suppliers may include Ethanol API manufacturers, exporters, distributors and traders.
click here to find a list of Ethanol 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 Ethanol Drug Master File in Japan (Ethanol JDMF) empowers Ethanol 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 Ethanol JDMF during the approval evaluation for pharmaceutical products. At the time of Ethanol 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 Ethanol suppliers with JDMF on PharmaCompass.
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