01 1Lundbeck Pharmaceuticals Italy S. p. A
01 1Diazoxide
01 1Denmark
Registration Number : 218MF10985
Registrant's Address : Via Quarta Strada, 2 Padova Italy
Initial Date of Registration : 2006-12-18
Latest Date of Registration : 2023-06-28
A Diazoxide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Diazoxide, including repackagers and relabelers. The FDA regulates Diazoxide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Diazoxide 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 Diazoxide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Diazoxide supplier is an individual or a company that provides Diazoxide active pharmaceutical ingredient (API) or Diazoxide finished formulations upon request. The Diazoxide suppliers may include Diazoxide API manufacturers, exporters, distributors and traders.
click here to find a list of Diazoxide 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 Diazoxide Drug Master File in Japan (Diazoxide JDMF) empowers Diazoxide 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 Diazoxide JDMF during the approval evaluation for pharmaceutical products. At the time of Diazoxide 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 Diazoxide suppliers with JDMF on PharmaCompass.
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