01 1Curia Spain S. A. U.
01 1Propionic acid alclometasone
01 1U.S.A
Registration Number : 218MF10892
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2006-11-10
Latest Date of Registration : 2006-11-10
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A Dominion brand of alclometasone dipropionate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dominion brand of alclometasone dipropionate, including repackagers and relabelers. The FDA regulates Dominion brand of alclometasone dipropionate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dominion brand of alclometasone dipropionate 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 Dominion brand of alclometasone dipropionate supplier is an individual or a company that provides Dominion brand of alclometasone dipropionate active pharmaceutical ingredient (API) or Dominion brand of alclometasone dipropionate finished formulations upon request. The Dominion brand of alclometasone dipropionate suppliers may include Dominion brand of alclometasone dipropionate 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 Dominion brand of alclometasone dipropionate Drug Master File in Japan (Dominion brand of alclometasone dipropionate JDMF) empowers Dominion brand of alclometasone dipropionate 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 Dominion brand of alclometasone dipropionate JDMF during the approval evaluation for pharmaceutical products. At the time of Dominion brand of alclometasone dipropionate 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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