01 1Johnson & Johnson Innovative Medicine
01 1CEFTOBIPROLE MEDOCARIL (R473928) DRUG SUBSTANCE
01 1U.S.A
01 1Inactive
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20446
Submission : 2007-05-03
Status : Inactive
Type : II
A Ceftobiprole Medocaril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ceftobiprole Medocaril, including repackagers and relabelers. The FDA regulates Ceftobiprole Medocaril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ceftobiprole Medocaril 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 Ceftobiprole Medocaril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ceftobiprole Medocaril supplier is an individual or a company that provides Ceftobiprole Medocaril active pharmaceutical ingredient (API) or Ceftobiprole Medocaril finished formulations upon request. The Ceftobiprole Medocaril suppliers may include Ceftobiprole Medocaril API manufacturers, exporters, distributors and traders.
click here to find a list of Ceftobiprole Medocaril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ceftobiprole Medocaril DMF (Drug Master File) is a document detailing the whole manufacturing process of Ceftobiprole Medocaril active pharmaceutical ingredient (API) in detail. Different forms of Ceftobiprole Medocaril DMFs exist exist since differing nations have different regulations, such as Ceftobiprole Medocaril USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ceftobiprole Medocaril DMF submitted to regulatory agencies in the US is known as a USDMF. Ceftobiprole Medocaril USDMF includes data on Ceftobiprole Medocaril's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ceftobiprole Medocaril USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ceftobiprole Medocaril suppliers with USDMF on PharmaCompass.
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