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