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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A Additive Screening Solution 40/Fluka kit no 78374 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Additive Screening Solution 40/Fluka kit no 78374, including repackagers and relabelers. The FDA regulates Additive Screening Solution 40/Fluka kit no 78374 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Additive Screening Solution 40/Fluka kit no 78374 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 Additive Screening Solution 40/Fluka kit no 78374 supplier is an individual or a company that provides Additive Screening Solution 40/Fluka kit no 78374 active pharmaceutical ingredient (API) or Additive Screening Solution 40/Fluka kit no 78374 finished formulations upon request. The Additive Screening Solution 40/Fluka kit no 78374 suppliers may include Additive Screening Solution 40/Fluka kit no 78374 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 Additive Screening Solution 40/Fluka kit no 78374 Drug Master File in Japan (Additive Screening Solution 40/Fluka kit no 78374 JDMF) empowers Additive Screening Solution 40/Fluka kit no 78374 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 Additive Screening Solution 40/Fluka kit no 78374 JDMF during the approval evaluation for pharmaceutical products. At the time of Additive Screening Solution 40/Fluka kit no 78374 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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