01 1Procos
01 1PIVAGABINE
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21796
Submission : 2008-07-09
Status : Inactive
Type : II
A Pivagabine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pivagabine, including repackagers and relabelers. The FDA regulates Pivagabine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pivagabine 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 Pivagabine supplier is an individual or a company that provides Pivagabine active pharmaceutical ingredient (API) or Pivagabine finished formulations upon request. The Pivagabine suppliers may include Pivagabine API manufacturers, exporters, distributors and traders.
click here to find a list of Pivagabine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Pivagabine DMF (Drug Master File) is a document detailing the whole manufacturing process of Pivagabine active pharmaceutical ingredient (API) in detail. Different forms of Pivagabine DMFs exist exist since differing nations have different regulations, such as Pivagabine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Pivagabine DMF submitted to regulatory agencies in the US is known as a USDMF. Pivagabine USDMF includes data on Pivagabine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pivagabine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Pivagabine suppliers with USDMF on PharmaCompass.
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