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