With Fermion, start the journey of your innovative API.
01 1Fermion Oy
01 1Mercaptopurine hydrate
01 1Finland
With Fermion, start the journey of your innovative API.
Registration Number : 218MF10968
Registrant's Address : Koivu-Mankkaan tie 6A, FI-02200 Espoo, Finland
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2021-02-16
A Purinethol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Purinethol, including repackagers and relabelers. The FDA regulates Purinethol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Purinethol 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 Purinethol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Purinethol supplier is an individual or a company that provides Purinethol active pharmaceutical ingredient (API) or Purinethol finished formulations upon request. The Purinethol suppliers may include Purinethol API manufacturers, exporters, distributors and traders.
click here to find a list of Purinethol 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 Purinethol Drug Master File in Japan (Purinethol JDMF) empowers Purinethol 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 Purinethol JDMF during the approval evaluation for pharmaceutical products. At the time of Purinethol 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 Purinethol suppliers with JDMF on PharmaCompass.
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