01 1Cambridge Isotope Laboratories
01 12-13C URACIL
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17837
Submission : 2004-11-18
Status : Active
Type : II
A Uracil-2-13C manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Uracil-2-13C, including repackagers and relabelers. The FDA regulates Uracil-2-13C manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Uracil-2-13C 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 Uracil-2-13C supplier is an individual or a company that provides Uracil-2-13C active pharmaceutical ingredient (API) or Uracil-2-13C finished formulations upon request. The Uracil-2-13C suppliers may include Uracil-2-13C API manufacturers, exporters, distributors and traders.
click here to find a list of Uracil-2-13C suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Uracil-2-13C DMF (Drug Master File) is a document detailing the whole manufacturing process of Uracil-2-13C active pharmaceutical ingredient (API) in detail. Different forms of Uracil-2-13C DMFs exist exist since differing nations have different regulations, such as Uracil-2-13C USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Uracil-2-13C DMF submitted to regulatory agencies in the US is known as a USDMF. Uracil-2-13C USDMF includes data on Uracil-2-13C's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Uracil-2-13C USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Uracil-2-13C suppliers with USDMF on PharmaCompass.
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