01 1Corden Pharma Bergamo S.p.A
01 1CARBADOX
01 1Italy
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5884
Submission : 1985-06-07
Status : Active
Type : II
A Carbadox manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Carbadox, including repackagers and relabelers. The FDA regulates Carbadox manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Carbadox 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 Carbadox manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Carbadox supplier is an individual or a company that provides Carbadox active pharmaceutical ingredient (API) or Carbadox finished formulations upon request. The Carbadox suppliers may include Carbadox API manufacturers, exporters, distributors and traders.
click here to find a list of Carbadox suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Carbadox DMF (Drug Master File) is a document detailing the whole manufacturing process of Carbadox active pharmaceutical ingredient (API) in detail. Different forms of Carbadox DMFs exist exist since differing nations have different regulations, such as Carbadox USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Carbadox DMF submitted to regulatory agencies in the US is known as a USDMF. Carbadox USDMF includes data on Carbadox's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Carbadox USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Carbadox suppliers with USDMF on PharmaCompass.
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