01 1Avanos
01 1[14C]-UREA, USP (PYTEST DRUG SUBSTANCE)
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18942
Submission : 2005-11-08
Status : Active
Type : II
21
PharmaCompass offers a list of Urea-14C API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Urea-14C manufacturer or Urea-14C supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Urea-14C manufacturer or Urea-14C supplier.
A Urea-14C manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Urea-14C, including repackagers and relabelers. The FDA regulates Urea-14C manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Urea-14C 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-14C supplier is an individual or a company that provides Urea-14C active pharmaceutical ingredient (API) or Urea-14C finished formulations upon request. The Urea-14C suppliers may include Urea-14C API manufacturers, exporters, distributors and traders.
click here to find a list of Urea-14C suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Urea-14C DMF (Drug Master File) is a document detailing the whole manufacturing process of Urea-14C active pharmaceutical ingredient (API) in detail. Different forms of Urea-14C DMFs exist exist since differing nations have different regulations, such as Urea-14C USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Urea-14C DMF submitted to regulatory agencies in the US is known as a USDMF. Urea-14C USDMF includes data on Urea-14C's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Urea-14C USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Urea-14C suppliers with USDMF on PharmaCompass.
