01 1Hangzhou Zhongmei Huadong Pharmaceutical
02 1Yifan Pharmaceutical
03 1Blank
01 3INSULIN DEGLUDEC
01 2China
02 1Blank
01 3Active
01 3Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42518
Submission : 2025-09-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41931
Submission : 2025-06-15
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39910
Submission : 2024-06-28
Status : Active
Type : II
Portfolio PDF
Product Web Link
Virtual Booth
Digital Content
Website
Corporate PDF
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PharmaCompass offers a list of Degludec API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Degludec manufacturer or Degludec supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Degludec manufacturer or Degludec supplier.
PharmaCompass also assists you with knowing the Degludec API Price utilized in the formulation of products. Degludec API Price is not always fixed or binding as the Degludec Price is obtained through a variety of data sources. The Degludec Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
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.
We have 2 companies offering Degludec
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