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