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.
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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 603430_ALDRICH manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 603430_ALDRICH, including repackagers and relabelers. The FDA regulates 603430_ALDRICH manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 603430_ALDRICH 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 603430_ALDRICH supplier is an individual or a company that provides 603430_ALDRICH active pharmaceutical ingredient (API) or 603430_ALDRICH finished formulations upon request. The 603430_ALDRICH suppliers may include 603430_ALDRICH 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 603430_ALDRICH Drug Master File in Japan (603430_ALDRICH JDMF) empowers 603430_ALDRICH 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 603430_ALDRICH JDMF during the approval evaluation for pharmaceutical products. At the time of 603430_ALDRICH 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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