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