Moehs Group, a reference company in the production of pharmaceutical active ingredients.
01 1MOEHS IBERICA S. L.
02 1Cambrex Karlskoga AB
03 1Delta Synthetic Co. , Ltd.
04 1SWATI SPENTOSE PRIVATE LIMITED
05 1SperaNexus Inc.
Moehs Group, a reference company in the production of pharmaceutical active ingredients.
Registration Number : 217MF11155
Registrant's Address : Cesar Martinell i Brunet 12A, Poligono Rubi Sur, Rubi (Barcelona), Spain
Initial Date of Registration : 2005-12-12
Latest Date of Registration : 2021-03-05
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A .alpha.-Diethylamino-2,6-acetoxylidide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of .alpha.-Diethylamino-2,6-acetoxylidide, including repackagers and relabelers. The FDA regulates .alpha.-Diethylamino-2,6-acetoxylidide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. .alpha.-Diethylamino-2,6-acetoxylidide 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 .alpha.-Diethylamino-2,6-acetoxylidide supplier is an individual or a company that provides .alpha.-Diethylamino-2,6-acetoxylidide active pharmaceutical ingredient (API) or .alpha.-Diethylamino-2,6-acetoxylidide finished formulations upon request. The .alpha.-Diethylamino-2,6-acetoxylidide suppliers may include .alpha.-Diethylamino-2,6-acetoxylidide 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 .alpha.-Diethylamino-2,6-acetoxylidide Drug Master File in Japan (.alpha.-Diethylamino-2,6-acetoxylidide JDMF) empowers .alpha.-Diethylamino-2,6-acetoxylidide 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 .alpha.-Diethylamino-2,6-acetoxylidide JDMF during the approval evaluation for pharmaceutical products. At the time of .alpha.-Diethylamino-2,6-acetoxylidide 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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We have 5 companies offering .alpha.-Diethylamino-2,6-acetoxylidide
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