Registration Number : 218MF10770
Registrant's Address : Strada Rivoltana Km 6/7 20090 Rodano Milano Italy
Initial Date of Registration : 2006-09-22
Latest Date of Registration : 2006-09-22
A Bumetanide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bumetanide, including repackagers and relabelers. The FDA regulates Bumetanide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bumetanide 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 Bumetanide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Bumetanide supplier is an individual or a company that provides Bumetanide active pharmaceutical ingredient (API) or Bumetanide finished formulations upon request. The Bumetanide suppliers may include Bumetanide API manufacturers, exporters, distributors and traders.
click here to find a list of Bumetanide 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 Bumetanide Drug Master File in Japan (Bumetanide JDMF) empowers Bumetanide 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 Bumetanide JDMF during the approval evaluation for pharmaceutical products. At the time of Bumetanide 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 Bumetanide suppliers with JDMF on PharmaCompass.
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