01 1ERREGIERRE S. p. A.
01 1URAAPIDIL
01 1Italy
Registration Number : 304MF10127
Registrant's Address : VIA F. BARACCA 19-24060 SAN PAOLO D'ARGON (BERGAMO) ITALY
Initial Date of Registration : 2022-08-31
Latest Date of Registration : 2022-08-31
A Urapidil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urapidil, including repackagers and relabelers. The FDA regulates Urapidil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urapidil 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 Urapidil manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Urapidil supplier is an individual or a company that provides Urapidil active pharmaceutical ingredient (API) or Urapidil finished formulations upon request. The Urapidil suppliers may include Urapidil API manufacturers, exporters, distributors and traders.
click here to find a list of Urapidil 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 Urapidil Drug Master File in Japan (Urapidil JDMF) empowers Urapidil 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 Urapidil JDMF during the approval evaluation for pharmaceutical products. At the time of Urapidil 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 Urapidil suppliers with JDMF on PharmaCompass.
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