01 1DSM Nutritional Products Ltd.
01 1Flucytosine
01 1Netherlands
Registration Number : 222MF10042
Registrant's Address : Wurmisweg 576, CH-4303, Kaiseraugst, Switzerland
Initial Date of Registration : 2010-02-04
Latest Date of Registration : 2021-12-22
A Fluocytosine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fluocytosine, including repackagers and relabelers. The FDA regulates Fluocytosine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fluocytosine 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 Fluocytosine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fluocytosine supplier is an individual or a company that provides Fluocytosine active pharmaceutical ingredient (API) or Fluocytosine finished formulations upon request. The Fluocytosine suppliers may include Fluocytosine API manufacturers, exporters, distributors and traders.
click here to find a list of Fluocytosine 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 Fluocytosine Drug Master File in Japan (Fluocytosine JDMF) empowers Fluocytosine 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 Fluocytosine JDMF during the approval evaluation for pharmaceutical products. At the time of Fluocytosine 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 Fluocytosine suppliers with JDMF on PharmaCompass.
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