01 1Shiratori Pharmaceutical Co., Ltd.
01 1Methylprednisolone sodium succinate
01 1Japan
Methylprednisolone Sodium Succinate
Registration Number : 217MF10323
Registrant's Address : 6-11-24 Tsudanuma, Narashino City, Chiba Prefecture
Initial Date of Registration : 2005-07-14
Latest Date of Registration : 2008-11-10
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A Methylprednisolone Sodium Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Methylprednisolone Sodium Succinate, including repackagers and relabelers. The FDA regulates Methylprednisolone Sodium Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Methylprednisolone Sodium Succinate 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 Methylprednisolone Sodium Succinate supplier is an individual or a company that provides Methylprednisolone Sodium Succinate active pharmaceutical ingredient (API) or Methylprednisolone Sodium Succinate finished formulations upon request. The Methylprednisolone Sodium Succinate suppliers may include Methylprednisolone Sodium Succinate 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 Methylprednisolone Sodium Succinate Drug Master File in Japan (Methylprednisolone Sodium Succinate JDMF) empowers Methylprednisolone Sodium Succinate 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 Methylprednisolone Sodium Succinate JDMF during the approval evaluation for pharmaceutical products. At the time of Methylprednisolone Sodium Succinate 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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