01 1Kern Pharma, S. L.
01 1Remifentanil hydrochloride
01 1Spain
Registration Number : 226MF10170
Registrant's Address : Pol. Ind. Colo(´)n II Venus, 72 08228 Terrassa (Barcelona)-Spain
Initial Date of Registration : 2014-09-01
Latest Date of Registration : 2018-10-12
A Remifentanil Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Remifentanil Hydrochloride, including repackagers and relabelers. The FDA regulates Remifentanil Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Remifentanil 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 Remifentanil Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Remifentanil Hydrochloride supplier is an individual or a company that provides Remifentanil Hydrochloride active pharmaceutical ingredient (API) or Remifentanil Hydrochloride finished formulations upon request. The Remifentanil Hydrochloride suppliers may include Remifentanil Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Remifentanil 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 Remifentanil Hydrochloride Drug Master File in Japan (Remifentanil Hydrochloride JDMF) empowers Remifentanil 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 Remifentanil Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Remifentanil 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 Remifentanil Hydrochloride suppliers with JDMF on PharmaCompass.
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