01 1Laboratorio Chimico Internazionale Spa
01 1PROPENTOFYLLINE INVESTIGATIONAL MEDICINAL PRODUCT DOSSIER
01 1Italy
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21637
Submission : 2008-05-16
Status : Inactive
Type : II
A Propentofylline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Propentofylline, including repackagers and relabelers. The FDA regulates Propentofylline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Propentofylline 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 Propentofylline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Propentofylline supplier is an individual or a company that provides Propentofylline active pharmaceutical ingredient (API) or Propentofylline finished formulations upon request. The Propentofylline suppliers may include Propentofylline API manufacturers, exporters, distributors and traders.
click here to find a list of Propentofylline suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Propentofylline DMF (Drug Master File) is a document detailing the whole manufacturing process of Propentofylline active pharmaceutical ingredient (API) in detail. Different forms of Propentofylline DMFs exist exist since differing nations have different regulations, such as Propentofylline USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Propentofylline DMF submitted to regulatory agencies in the US is known as a USDMF. Propentofylline USDMF includes data on Propentofylline's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Propentofylline USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Propentofylline suppliers with USDMF on PharmaCompass.
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