01 1RUYUAN HEC PHARM CO. , LTD.
01 1Fingolimod Hydrochloride
01 1China
Registration Number : 304MF10011
Registrant's Address : Xiaba Development Zone, Ruyuan County, Shaoguan City, Guangdong Province, P. R. China
Initial Date of Registration : 2022-01-13
Latest Date of Registration : 2022-01-13
A gilenya manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gilenya, including repackagers and relabelers. The FDA regulates gilenya manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gilenya 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 gilenya manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A gilenya supplier is an individual or a company that provides gilenya active pharmaceutical ingredient (API) or gilenya finished formulations upon request. The gilenya suppliers may include gilenya API manufacturers, exporters, distributors and traders.
click here to find a list of gilenya 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 gilenya Drug Master File in Japan (gilenya JDMF) empowers gilenya 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 gilenya JDMF during the approval evaluation for pharmaceutical products. At the time of gilenya 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 gilenya suppliers with JDMF on PharmaCompass.
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