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 Fingolimod Hydrochloride manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fingolimod Hydrochloride, including repackagers and relabelers. The FDA regulates Fingolimod Hydrochloride manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fingolimod Hydrochloride 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 Fingolimod Hydrochloride manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fingolimod Hydrochloride supplier is an individual or a company that provides Fingolimod Hydrochloride active pharmaceutical ingredient (API) or Fingolimod Hydrochloride finished formulations upon request. The Fingolimod Hydrochloride suppliers may include Fingolimod Hydrochloride API manufacturers, exporters, distributors and traders.
click here to find a list of Fingolimod Hydrochloride 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 Fingolimod Hydrochloride Drug Master File in Japan (Fingolimod Hydrochloride JDMF) empowers Fingolimod Hydrochloride 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 Fingolimod Hydrochloride JDMF during the approval evaluation for pharmaceutical products. At the time of Fingolimod Hydrochloride 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 Fingolimod Hydrochloride suppliers with JDMF on PharmaCompass.
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