01 1Arevipharma GmbH
02 1Kern Pharma, S. L.
03 2SpecGx LLC
01 1Fentanyl Citrate
02 2Fentanyl citrate
03 1Fentanyl citrate FP
01 1Germany
02 2Ireland
03 1Spain
Registration Number : 306MF10148
Registrant's Address : Meissner Strasse 35 D-01445 Radebeul, Germany
Initial Date of Registration : 2024-11-20
Latest Date of Registration : 2024-11-20
Registration Number : 226MF10217
Registrant's Address : Pol. Ind. Colo(´)n II Venus, 72 08228 Terrassa (Barcelona)-Spain
Initial Date of Registration : 2014-11-17
Latest Date of Registration : 2022-06-01
Registration Number : 229MF10161
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2017-08-17
Latest Date of Registration : 2017-08-17
Registration Number : 218MF10580
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2006-06-22
Latest Date of Registration : 2006-06-22
A Fentanyl Citrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fentanyl Citrate, including repackagers and relabelers. The FDA regulates Fentanyl Citrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fentanyl Citrate 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 Fentanyl Citrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fentanyl Citrate supplier is an individual or a company that provides Fentanyl Citrate active pharmaceutical ingredient (API) or Fentanyl Citrate finished formulations upon request. The Fentanyl Citrate suppliers may include Fentanyl Citrate API manufacturers, exporters, distributors and traders.
click here to find a list of Fentanyl Citrate 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 Fentanyl Citrate Drug Master File in Japan (Fentanyl Citrate JDMF) empowers Fentanyl Citrate 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 Fentanyl Citrate JDMF during the approval evaluation for pharmaceutical products. At the time of Fentanyl Citrate 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 Fentanyl Citrate suppliers with JDMF on PharmaCompass.
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