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 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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