EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
01 1SANOFI WINTHROP INDUSTRIE
01 1Naloxone hydrochloride hydrate
01 1France
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Naloxone hydrochloride hydrate
Registration Number : 218MF10971
Registrant's Address : 82 Avenue Raspail 94250 Gentilly France
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2019-03-19
A Naloxone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naloxone, including repackagers and relabelers. The FDA regulates Naloxone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naloxone 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 Naloxone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naloxone supplier is an individual or a company that provides Naloxone active pharmaceutical ingredient (API) or Naloxone finished formulations upon request. The Naloxone suppliers may include Naloxone API manufacturers, exporters, distributors and traders.
click here to find a list of Naloxone 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 Naloxone Drug Master File in Japan (Naloxone JDMF) empowers Naloxone 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 Naloxone JDMF during the approval evaluation for pharmaceutical products. At the time of Naloxone 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 Naloxone suppliers with JDMF on PharmaCompass.
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