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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urapidil Hydrochloride, including repackagers and relabelers. The FDA regulates Urapidil Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urapidil Hydrochloride 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 Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Urapidil Hydrochloride supplier is an individual or a company that provides Urapidil Hydrochloride active pharmaceutical ingredient (API) or Urapidil Hydrochloride finished formulations upon request. The Urapidil Hydrochloride suppliers may include Urapidil Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Urapidil Hydrochloride 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 Hydrochloride Drug Master File in Japan (Urapidil Hydrochloride JDMF) empowers Urapidil Hydrochloride 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 Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Urapidil Hydrochloride 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 Hydrochloride suppliers with JDMF on PharmaCompass.
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