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