01 1Procos
01 1ALVERINE CITRATE
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 29917
Submission : 2015-10-06
Status : Inactive
Type : II
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A Spasmaverine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spasmaverine, including repackagers and relabelers. The FDA regulates Spasmaverine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spasmaverine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Spasmaverine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Spasmaverine supplier is an individual or a company that provides Spasmaverine active pharmaceutical ingredient (API) or Spasmaverine finished formulations upon request. The Spasmaverine suppliers may include Spasmaverine API manufacturers, exporters, distributors and traders.
click here to find a list of Spasmaverine suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Spasmaverine DMF (Drug Master File) is a document detailing the whole manufacturing process of Spasmaverine active pharmaceutical ingredient (API) in detail. Different forms of Spasmaverine DMFs exist exist since differing nations have different regulations, such as Spasmaverine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Spasmaverine DMF submitted to regulatory agencies in the US is known as a USDMF. Spasmaverine USDMF includes data on Spasmaverine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Spasmaverine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Spasmaverine suppliers with USDMF on PharmaCompass.
