01 2Daiichi Sankyo
02 1Nippon Soda
01 1FAROPENEM DALOXATE
02 2SUN A0026 DRUG SUBSTANCE
01 3Japan
01 3Inactive
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14614
Submission : 1999-12-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10570
Submission : 1993-11-04
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14988
Submission : 2000-08-08
Status : Inactive
Type : II
A Faropenem Medoxomil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Faropenem Medoxomil, including repackagers and relabelers. The FDA regulates Faropenem Medoxomil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Faropenem Medoxomil 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 Faropenem Medoxomil supplier is an individual or a company that provides Faropenem Medoxomil active pharmaceutical ingredient (API) or Faropenem Medoxomil finished formulations upon request. The Faropenem Medoxomil suppliers may include Faropenem Medoxomil API manufacturers, exporters, distributors and traders.
click here to find a list of Faropenem Medoxomil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Faropenem Medoxomil DMF (Drug Master File) is a document detailing the whole manufacturing process of Faropenem Medoxomil active pharmaceutical ingredient (API) in detail. Different forms of Faropenem Medoxomil DMFs exist exist since differing nations have different regulations, such as Faropenem Medoxomil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Faropenem Medoxomil DMF submitted to regulatory agencies in the US is known as a USDMF. Faropenem Medoxomil USDMF includes data on Faropenem Medoxomil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Faropenem Medoxomil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Faropenem Medoxomil suppliers with USDMF on PharmaCompass.
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