01 1Takasugi Pharmaceutical Co., Ltd.
01 1Japanese Pharmacopoeia (production only) urea
01 1Japan
Japanese Pharmacopoeia (for manufacturing purposes 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.
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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 Elaqua xx manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Elaqua xx, including repackagers and relabelers. The FDA regulates Elaqua xx manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Elaqua xx API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Elaqua xx supplier is an individual or a company that provides Elaqua xx active pharmaceutical ingredient (API) or Elaqua xx finished formulations upon request. The Elaqua xx suppliers may include Elaqua xx API manufacturers, exporters, distributors and traders.
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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 Elaqua xx Drug Master File in Japan (Elaqua xx JDMF) empowers Elaqua xx 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 Elaqua xx JDMF during the approval evaluation for pharmaceutical products. At the time of Elaqua xx JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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