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
A UREA C-13 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of UREA C-13, including repackagers and relabelers. The FDA regulates UREA C-13 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. UREA C-13 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 C-13 supplier is an individual or a company that provides UREA C-13 active pharmaceutical ingredient (API) or UREA C-13 finished formulations upon request. The UREA C-13 suppliers may include UREA C-13 API manufacturers, exporters, distributors and traders.
click here to find a list of UREA C-13 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 C-13 Drug Master File in Japan (UREA C-13 JDMF) empowers UREA C-13 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 C-13 JDMF during the approval evaluation for pharmaceutical products. At the time of UREA C-13 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 C-13 suppliers with JDMF on PharmaCompass.
We have 1 companies offering UREA C-13
Get in contact with the supplier of your choice:
LOOKING FOR A SUPPLIER?
