01 1DNP Fine Chemicals Utsunomiya Co., Ltd.
01 1Benzo phosphate succinate (ground product)
01 1Japan
Cibenzoline succinate (crushed product)
Registration Number : 229MF10048
Registrant's Address : 1062-8 Honjo, Nishikata-cho, Tochigi City, Tochigi Prefecture
Initial Date of Registration : 2017-02-22
Latest Date of Registration : 2017-02-22
A Succinyl phosphate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Succinyl phosphate, including repackagers and relabelers. The FDA regulates Succinyl phosphate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Succinyl phosphate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Succinyl phosphate supplier is an individual or a company that provides Succinyl phosphate active pharmaceutical ingredient (API) or Succinyl phosphate finished formulations upon request. The Succinyl phosphate suppliers may include Succinyl phosphate API manufacturers, exporters, distributors and traders.
click here to find a list of Succinyl phosphate 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 Succinyl phosphate Drug Master File in Japan (Succinyl phosphate JDMF) empowers Succinyl phosphate 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 Succinyl phosphate JDMF during the approval evaluation for pharmaceutical products. At the time of Succinyl phosphate 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 Succinyl phosphate suppliers with JDMF on PharmaCompass.
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