01 1Maprimed
02 1Quimica Sintetica
01 1BENZNIDAZOLE
02 1BENZNIDAZOLE (CODE 50954)
01 1Argentina
02 1Spain
01 1Active
02 1Inactive
01 2Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28359
Submission : 2014-12-15
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30195
Submission : 2016-06-27
Status : Active
Type : II
A Benznidazole manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Benznidazole, including repackagers and relabelers. The FDA regulates Benznidazole manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Benznidazole 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 Benznidazole manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Benznidazole supplier is an individual or a company that provides Benznidazole active pharmaceutical ingredient (API) or Benznidazole finished formulations upon request. The Benznidazole suppliers may include Benznidazole API manufacturers, exporters, distributors and traders.
click here to find a list of Benznidazole suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Benznidazole DMF (Drug Master File) is a document detailing the whole manufacturing process of Benznidazole active pharmaceutical ingredient (API) in detail. Different forms of Benznidazole DMFs exist exist since differing nations have different regulations, such as Benznidazole USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Benznidazole DMF submitted to regulatory agencies in the US is known as a USDMF. Benznidazole USDMF includes data on Benznidazole's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Benznidazole USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Benznidazole suppliers with USDMF on PharmaCompass.
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