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01 1INSULIN DEGLUDEC
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USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39910
Submission : 2024-06-28
Status : Active
Type : II
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A Degludec manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Degludec, including repackagers and relabelers. The FDA regulates Degludec manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Degludec 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 Degludec manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Degludec supplier is an individual or a company that provides Degludec active pharmaceutical ingredient (API) or Degludec finished formulations upon request. The Degludec suppliers may include Degludec API manufacturers, exporters, distributors and traders.
click here to find a list of Degludec suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Degludec DMF (Drug Master File) is a document detailing the whole manufacturing process of Degludec active pharmaceutical ingredient (API) in detail. Different forms of Degludec DMFs exist exist since differing nations have different regulations, such as Degludec USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Degludec DMF submitted to regulatory agencies in the US is known as a USDMF. Degludec USDMF includes data on Degludec's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Degludec USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Degludec suppliers with USDMF on PharmaCompass.
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