01 2Wisdom Pharmaceutical Co. , Ltd.
01 1Fasudil Hydrochloride Hydrate
02 1Fasudil hydrochloride hydrate
01 2China
Registration Number : 228MF10174
Registrant's Address : No. 18 Qinghua Road, Sanchang, Haimen, Jiangsu, China
Initial Date of Registration : 2016-08-29
Latest Date of Registration : 2016-08-29
Registration Number : 231MF10048
Registrant's Address : No. 18 Qinghua Road, Sanchang, Haimen, Jiangsu, China
Initial Date of Registration : 2019-02-15
Latest Date of Registration : 2022-03-02
A Fasudil hydrochloride hemihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fasudil hydrochloride hemihydrate, including repackagers and relabelers. The FDA regulates Fasudil hydrochloride hemihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fasudil hydrochloride hemihydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Fasudil hydrochloride hemihydrate supplier is an individual or a company that provides Fasudil hydrochloride hemihydrate active pharmaceutical ingredient (API) or Fasudil hydrochloride hemihydrate finished formulations upon request. The Fasudil hydrochloride hemihydrate suppliers may include Fasudil hydrochloride hemihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of Fasudil hydrochloride hemihydrate 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 Fasudil hydrochloride hemihydrate Drug Master File in Japan (Fasudil hydrochloride hemihydrate JDMF) empowers Fasudil hydrochloride hemihydrate 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 Fasudil hydrochloride hemihydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Fasudil hydrochloride hemihydrate 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 Fasudil hydrochloride hemihydrate suppliers with JDMF on PharmaCompass.
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