01 1Fine Chemicals Corporation (Pty) Limited
02 1Cambrex Charles City, Inc.
03 1SpecGx LLC
01 3Fentanyl
01 1Ireland
02 1South Africa
03 1U.S.A
Registration Number : 227MF10059
Registrant's Address : 15 Hawkins Avenue, Epping 1,7460, Cape Town, South Africa
Initial Date of Registration : 2015-03-06
Latest Date of Registration : 2024-03-13
Registration Number : 222MF10279
Registrant's Address : 1205 11th Street, Charles City, Iowa, U.S. S. A.
Initial Date of Registration : 2010-12-24
Latest Date of Registration : 2010-12-24
Registration Number : 221MF10283
Registrant's Address : 385 Marshall Ave, Webster Groves, Missouri 63119, United States
Initial Date of Registration : 2009-12-22
Latest Date of Registration : 2018-05-31
A Fentanyl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fentanyl, including repackagers and relabelers. The FDA regulates Fentanyl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fentanyl 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 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fentanyl supplier is an individual or a company that provides Fentanyl active pharmaceutical ingredient (API) or Fentanyl finished formulations upon request. The Fentanyl suppliers may include Fentanyl API manufacturers, exporters, distributors and traders.
click here to find a list of Fentanyl 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 Drug Master File in Japan (Fentanyl JDMF) empowers Fentanyl 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 JDMF during the approval evaluation for pharmaceutical products. At the time of Fentanyl 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 suppliers with JDMF on PharmaCompass.
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