01 1Takasugi Pharmaceutical Co., Ltd.
01 1Japanese Pharmacopoeia (production only) urea
01 1Japan
Japanese Pharmacopoeia (for manufacturing only) Urea
Registration Number : 218MF10723
Registrant's Address : 2-7-26 Yoshizuka, Hakata-ku, Fukuoka City, Fukuoka Prefecture
Initial Date of Registration : 2006-09-06
Latest Date of Registration : 2006-09-06
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PharmaCompass offers a list of Urea API API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Urea API manufacturer or Urea API supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Urea API manufacturer or Urea API supplier.
PharmaCompass also assists you with knowing the Urea API API Price utilized in the formulation of products. Urea API API Price is not always fixed or binding as the Urea API Price is obtained through a variety of data sources. The Urea API Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A URE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of URE, including repackagers and relabelers. The FDA regulates URE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. URE 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 URE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A URE supplier is an individual or a company that provides URE active pharmaceutical ingredient (API) or URE finished formulations upon request. The URE suppliers may include URE API manufacturers, exporters, distributors and traders.
click here to find a list of URE 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 URE Drug Master File in Japan (URE JDMF) empowers URE 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 URE JDMF during the approval evaluation for pharmaceutical products. At the time of URE 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 URE suppliers with JDMF on PharmaCompass.
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