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01 1SANOFI WINTHROP INDUSTRIE
01 1Naloxone hydrochloride hydrate
01 1France
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 Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Naloxone Hydrochloride, including repackagers and relabelers. The FDA regulates Naloxone Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Naloxone 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 Naloxone Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Naloxone Hydrochloride supplier is an individual or a company that provides Naloxone Hydrochloride active pharmaceutical ingredient (API) or Naloxone Hydrochloride finished formulations upon request. The Naloxone Hydrochloride suppliers may include Naloxone Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Naloxone 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 Naloxone Hydrochloride Drug Master File in Japan (Naloxone Hydrochloride JDMF) empowers Naloxone 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 Naloxone Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Naloxone 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 Naloxone Hydrochloride suppliers with JDMF on PharmaCompass.
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