01 1AMINO GmbH
01 1Betaine anhydrous
01 1Germany
Registration Number : 225MF10183
Registrant's Address : An der Zucker-Raffinerie 9, 38373 Frellstedt, Germany
Initial Date of Registration : 2013-09-25
Latest Date of Registration : 2023-09-13
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PharmaCompass offers a list of Betaine 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 Betaine manufacturer or Betaine supplier for your needs.
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A 11070-EP2314590A1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 11070-EP2314590A1, including repackagers and relabelers. The FDA regulates 11070-EP2314590A1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 11070-EP2314590A1 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 11070-EP2314590A1 supplier is an individual or a company that provides 11070-EP2314590A1 active pharmaceutical ingredient (API) or 11070-EP2314590A1 finished formulations upon request. The 11070-EP2314590A1 suppliers may include 11070-EP2314590A1 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 11070-EP2314590A1 Drug Master File in Japan (11070-EP2314590A1 JDMF) empowers 11070-EP2314590A1 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 11070-EP2314590A1 JDMF during the approval evaluation for pharmaceutical products. At the time of 11070-EP2314590A1 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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