01 1Hainan Simcere Pharmaceutical Co. , Ltd.
02 1Jiangsu Chiatai Qingjiang Pharmaceutical Co. , Ltd.
03 1Jiangsu Runan Pharmaceutical Co. , Ltd.
01 1Igurati mod
02 2Iguratimod
01 3China
Registration Number : 305MF10057
Registrant's Address : No. 12 Zhangma Road, Salt and Chemical New Materials Industrial Park, Huai'an Jiangsu...
Initial Date of Registration : 2023-05-10
Latest Date of Registration : 2024-07-24
Registration Number : 302MF10085
Registrant's Address : No. 9 Hantai North Road, Qinghe District, Huai'an City, Jiangsu Province, P. R. China
Initial Date of Registration : 2020-07-22
Latest Date of Registration : 2023-08-02
Registration Number : 302MF10127
Registrant's Address : No. 2, Yaogu 3rd Road, Pharma Valley, Xiuying District, Haikou City, Hainan Province,...
Initial Date of Registration : 2020-10-14
Latest Date of Registration : 2020-10-14
A Iguratimod manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Iguratimod, including repackagers and relabelers. The FDA regulates Iguratimod manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Iguratimod 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 Iguratimod manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Iguratimod supplier is an individual or a company that provides Iguratimod active pharmaceutical ingredient (API) or Iguratimod finished formulations upon request. The Iguratimod suppliers may include Iguratimod API manufacturers, exporters, distributors and traders.
click here to find a list of Iguratimod 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 Iguratimod Drug Master File in Japan (Iguratimod JDMF) empowers Iguratimod 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 Iguratimod JDMF during the approval evaluation for pharmaceutical products. At the time of Iguratimod 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 Iguratimod suppliers with JDMF on PharmaCompass.
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