01 1CSPC Pharmaceutical Group
01 1COBAMAMIDE
01 1China
01 1Active
01 1Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22976
Submission : 2009-04-21
Status : Active
Type : II
A Cobamamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Cobamamide, including repackagers and relabelers. The FDA regulates Cobamamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Cobamamide 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 Cobamamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Cobamamide supplier is an individual or a company that provides Cobamamide active pharmaceutical ingredient (API) or Cobamamide finished formulations upon request. The Cobamamide suppliers may include Cobamamide API manufacturers, exporters, distributors and traders.
click here to find a list of Cobamamide suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Cobamamide DMF (Drug Master File) is a document detailing the whole manufacturing process of Cobamamide active pharmaceutical ingredient (API) in detail. Different forms of Cobamamide DMFs exist exist since differing nations have different regulations, such as Cobamamide USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Cobamamide DMF submitted to regulatory agencies in the US is known as a USDMF. Cobamamide USDMF includes data on Cobamamide's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Cobamamide USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Cobamamide suppliers with USDMF on PharmaCompass.
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