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