01 1LOBA Feinchemie Gmbh
02 1Regis Technologies
01 13,4-DIAMINOPYRIDINE
02 1ANTIVIROGRAM (DOCUMENT IDENTIFICATION: VIRCO/FDA/98001) IN MECHELEN, BELGIUM.
01 1Austria
02 1U.S.A
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30568
Submission : 2016-05-23
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5668
Submission : 1985-01-23
Status : Inactive
Type : II
A Amifampridine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amifampridine, including repackagers and relabelers. The FDA regulates Amifampridine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amifampridine 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 Amifampridine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amifampridine supplier is an individual or a company that provides Amifampridine active pharmaceutical ingredient (API) or Amifampridine finished formulations upon request. The Amifampridine suppliers may include Amifampridine API manufacturers, exporters, distributors and traders.
click here to find a list of Amifampridine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Amifampridine DMF (Drug Master File) is a document detailing the whole manufacturing process of Amifampridine active pharmaceutical ingredient (API) in detail. Different forms of Amifampridine DMFs exist exist since differing nations have different regulations, such as Amifampridine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amifampridine DMF submitted to regulatory agencies in the US is known as a USDMF. Amifampridine USDMF includes data on Amifampridine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amifampridine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amifampridine suppliers with USDMF on PharmaCompass.
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