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