01 1Sogo Pharmaceutical Co., Ltd.
01 1Hydrocortisone succinate
01 1Japan
Registration Number : 219MF10308
Registrant's Address : 2-6-2 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2007-10-05
Latest Date of Registration : 2007-10-05
A Hydrocortisone Sodium Succinate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrocortisone Sodium Succinate, including repackagers and relabelers. The FDA regulates Hydrocortisone Sodium Succinate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrocortisone 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.
click here to find a list of Hydrocortisone Sodium Succinate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrocortisone Sodium Succinate supplier is an individual or a company that provides Hydrocortisone Sodium Succinate active pharmaceutical ingredient (API) or Hydrocortisone Sodium Succinate finished formulations upon request. The Hydrocortisone Sodium Succinate suppliers may include Hydrocortisone Sodium Succinate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrocortisone Sodium Succinate 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 Hydrocortisone Sodium Succinate Drug Master File in Japan (Hydrocortisone Sodium Succinate JDMF) empowers Hydrocortisone 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 Hydrocortisone Sodium Succinate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydrocortisone 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.
click here to find a list of Hydrocortisone Sodium Succinate suppliers with JDMF on PharmaCompass.
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