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02 1Tonghua Dongbao Pharma
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01 2INSULIN GLARGINE
02 1INSULIN GLARGINE (RDNA ORIGIN)
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 27093
Submission : 2013-05-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36695
Submission : 2022-02-16
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41930
Submission : 2025-05-21
Status : Active
Type : II
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PharmaCompass offers a list of Insulin Glargine 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 Insulin Glargine manufacturer or Insulin Glargine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Insulin Glargine manufacturer or Insulin Glargine supplier.
PharmaCompass also assists you with knowing the Insulin Glargine API Price utilized in the formulation of products. Insulin Glargine API Price is not always fixed or binding as the Insulin Glargine Price is obtained through a variety of data sources. The Insulin Glargine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A insulin, Gly(A21)-Arg(B31,B32)- manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of insulin, Gly(A21)-Arg(B31,B32)-, including repackagers and relabelers. The FDA regulates insulin, Gly(A21)-Arg(B31,B32)- manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. insulin, Gly(A21)-Arg(B31,B32)- API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A insulin, Gly(A21)-Arg(B31,B32)- supplier is an individual or a company that provides insulin, Gly(A21)-Arg(B31,B32)- active pharmaceutical ingredient (API) or insulin, Gly(A21)-Arg(B31,B32)- finished formulations upon request. The insulin, Gly(A21)-Arg(B31,B32)- suppliers may include insulin, Gly(A21)-Arg(B31,B32)- API manufacturers, exporters, distributors and traders.
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A insulin, Gly(A21)-Arg(B31,B32)- DMF (Drug Master File) is a document detailing the whole manufacturing process of insulin, Gly(A21)-Arg(B31,B32)- active pharmaceutical ingredient (API) in detail. Different forms of insulin, Gly(A21)-Arg(B31,B32)- DMFs exist exist since differing nations have different regulations, such as insulin, Gly(A21)-Arg(B31,B32)- USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A insulin, Gly(A21)-Arg(B31,B32)- DMF submitted to regulatory agencies in the US is known as a USDMF. insulin, Gly(A21)-Arg(B31,B32)- USDMF includes data on insulin, Gly(A21)-Arg(B31,B32)-'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The insulin, Gly(A21)-Arg(B31,B32)- USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of insulin, Gly(A21)-Arg(B31,B32)- suppliers with USDMF on PharmaCompass.
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