01 1Osaka Synthetic Organic Chemistry Laboratory Co., Ltd.
01 1Only the Japanese Pharmacopoeia ifenprodil tartrate salt production
01 1Japan
Japanese Pharmacopoeia Ifenprodil Tartrate For manufacturing only
Registration Number : 218MF10594
Registrant's Address : 1-1-2 Nishinomiyahama, Nishinomiya City, Hyogo Prefecture
Initial Date of Registration : 2006-06-22
Latest Date of Registration : 2006-06-22
A Cerocral manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cerocral, including repackagers and relabelers. The FDA regulates Cerocral manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cerocral 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 Cerocral supplier is an individual or a company that provides Cerocral active pharmaceutical ingredient (API) or Cerocral finished formulations upon request. The Cerocral suppliers may include Cerocral API manufacturers, exporters, distributors and traders.
click here to find a list of Cerocral 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 Cerocral Drug Master File in Japan (Cerocral JDMF) empowers Cerocral 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 Cerocral JDMF during the approval evaluation for pharmaceutical products. At the time of Cerocral 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 Cerocral suppliers with JDMF on PharmaCompass.
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