01 1Ace Japan Co., Ltd.
01 1Japanese Pharmacopoeia sucralfate hydrate
01 1Japan
Japanese Pharmacopoeia Sucralfate Hydrate
Registration Number : 218MF10954
Registrant's Address : 5850-1 Higashine-ko, Higashine City, Yamagata Prefecture
Initial Date of Registration : 2006-11-24
Latest Date of Registration : 2006-11-24
A Sucralfate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sucralfate, including repackagers and relabelers. The FDA regulates Sucralfate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sucralfate 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 Sucralfate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sucralfate supplier is an individual or a company that provides Sucralfate active pharmaceutical ingredient (API) or Sucralfate finished formulations upon request. The Sucralfate suppliers may include Sucralfate API manufacturers, exporters, distributors and traders.
click here to find a list of Sucralfate 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 Sucralfate Drug Master File in Japan (Sucralfate JDMF) empowers Sucralfate 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 Sucralfate JDMF during the approval evaluation for pharmaceutical products. At the time of Sucralfate 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 Sucralfate suppliers with JDMF on PharmaCompass.
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