01 1Esteve Quimica
01 1VPA-985
01 1Spain
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12615
Submission : 1997-07-29
Status : Inactive
Type : II
A Lixivaptan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lixivaptan, including repackagers and relabelers. The FDA regulates Lixivaptan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lixivaptan 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 Lixivaptan supplier is an individual or a company that provides Lixivaptan active pharmaceutical ingredient (API) or Lixivaptan finished formulations upon request. The Lixivaptan suppliers may include Lixivaptan API manufacturers, exporters, distributors and traders.
click here to find a list of Lixivaptan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lixivaptan DMF (Drug Master File) is a document detailing the whole manufacturing process of Lixivaptan active pharmaceutical ingredient (API) in detail. Different forms of Lixivaptan DMFs exist exist since differing nations have different regulations, such as Lixivaptan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lixivaptan DMF submitted to regulatory agencies in the US is known as a USDMF. Lixivaptan USDMF includes data on Lixivaptan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lixivaptan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lixivaptan suppliers with USDMF on PharmaCompass.
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