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 Macrogol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Macrogol, including repackagers and relabelers. The FDA regulates Macrogol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Macrogol 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 Macrogol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Macrogol supplier is an individual or a company that provides Macrogol active pharmaceutical ingredient (API) or Macrogol finished formulations upon request. The Macrogol suppliers may include Macrogol API manufacturers, exporters, distributors and traders.
click here to find a list of Macrogol 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 Macrogol Drug Master File in Japan (Macrogol JDMF) empowers Macrogol 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 Macrogol JDMF during the approval evaluation for pharmaceutical products. At the time of Macrogol 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 Macrogol suppliers with JDMF on PharmaCompass.
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