01 1Clariant Products (Deutschland) GmbH
02 1Sanyo Chemical Industries, Ltd.
01 1Macrogol 4000 (Hunmatsu)
02 1Polyglykol 3350
01 1Japan
02 1Switzerland
Registration Number : 229MF10099
Registrant's Address : Bru(¨)ningstraβe 50, D-65926 Frankfurt/Main
Initial Date of Registration : 2017-05-29
Latest Date of Registration : 2022-10-19
Registration Number : 304MF10097
Registrant's Address : 11-1 Hitotsubashi-no-motocho, Higashiyama-ku, Kyoto City, Kyoto Prefecture
Initial Date of Registration : 2022-07-06
Latest Date of Registration : 2023-04-19
A Ethylene Glycol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ethylene Glycol, including repackagers and relabelers. The FDA regulates Ethylene Glycol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ethylene Glycol 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 Ethylene Glycol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ethylene Glycol supplier is an individual or a company that provides Ethylene Glycol active pharmaceutical ingredient (API) or Ethylene Glycol finished formulations upon request. The Ethylene Glycol suppliers may include Ethylene Glycol API manufacturers, exporters, distributors and traders.
click here to find a list of Ethylene Glycol 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 Ethylene Glycol Drug Master File in Japan (Ethylene Glycol JDMF) empowers Ethylene Glycol 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 Ethylene Glycol JDMF during the approval evaluation for pharmaceutical products. At the time of Ethylene Glycol 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 Ethylene Glycol suppliers with JDMF on PharmaCompass.
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