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