01 1Fushimi Pharmaceutical Co., Ltd.
01 1Homo sulfamine (for manufacturing only)
01 1Japan
Homosulfamine (for manufacturing only)
Registration Number : 231MF10085
Registrant's Address : 1676 Nakatsucho, Marugame City, Kagawa Prefecture
Initial Date of Registration : 2019-04-09
Latest Date of Registration : 2019-04-09
A Sulfanilamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sulfanilamide, including repackagers and relabelers. The FDA regulates Sulfanilamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sulfanilamide 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 Sulfanilamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Sulfanilamide supplier is an individual or a company that provides Sulfanilamide active pharmaceutical ingredient (API) or Sulfanilamide finished formulations upon request. The Sulfanilamide suppliers may include Sulfanilamide API manufacturers, exporters, distributors and traders.
click here to find a list of Sulfanilamide 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 Sulfanilamide Drug Master File in Japan (Sulfanilamide JDMF) empowers Sulfanilamide 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 Sulfanilamide JDMF during the approval evaluation for pharmaceutical products. At the time of Sulfanilamide 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 Sulfanilamide suppliers with JDMF on PharmaCompass.
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