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