01 1KREITCHMAN PET CENTER
01 1[11C]-MDL100907
01 1U.S.A
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27703
Submission : 2013-10-21
Status : Active
Type : II
A Volinanserin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Volinanserin, including repackagers and relabelers. The FDA regulates Volinanserin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Volinanserin 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 Volinanserin supplier is an individual or a company that provides Volinanserin active pharmaceutical ingredient (API) or Volinanserin finished formulations upon request. The Volinanserin suppliers may include Volinanserin API manufacturers, exporters, distributors and traders.
click here to find a list of Volinanserin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Volinanserin DMF (Drug Master File) is a document detailing the whole manufacturing process of Volinanserin active pharmaceutical ingredient (API) in detail. Different forms of Volinanserin DMFs exist exist since differing nations have different regulations, such as Volinanserin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Volinanserin DMF submitted to regulatory agencies in the US is known as a USDMF. Volinanserin USDMF includes data on Volinanserin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Volinanserin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Volinanserin suppliers with USDMF on PharmaCompass.
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