01 1Cambridge Isotope Laboratories, Inc.
01 1urea(13C)
01 1U.S.A
Registration Number : 221MF10045
Registrant's Address : 3 Highwood Drive, Tewksbury, MA 01876, USA
Initial Date of Registration : 2009-02-25
Latest Date of Registration : 2018-11-16
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PharmaCompass offers a list of Urea C13 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 C13 manufacturer or Urea C13 supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Urea C13 manufacturer or Urea C13 supplier.
PharmaCompass also assists you with knowing the Urea C13 API Price utilized in the formulation of products. Urea C13 API Price is not always fixed or binding as the Urea C13 Price is obtained through a variety of data sources. The Urea C13 Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Urea C13 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urea C13, including repackagers and relabelers. The FDA regulates Urea C13 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urea C13 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 Urea C13 supplier is an individual or a company that provides Urea C13 active pharmaceutical ingredient (API) or Urea C13 finished formulations upon request. The Urea C13 suppliers may include Urea C13 API manufacturers, exporters, distributors and traders.
click here to find a list of Urea C13 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 C13 Drug Master File in Japan (Urea C13 JDMF) empowers Urea C13 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 C13 JDMF during the approval evaluation for pharmaceutical products. At the time of Urea C13 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 C13 suppliers with JDMF on PharmaCompass.
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