01 1Biocon
02 1Tonghua Dongbao Pharma
01 1INSULIN GLARGINE
02 1INSULIN GLARGINE (RDNA ORIGIN)
01 1China
02 1India
01 2Active
01 2Blank
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
14
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 Glargine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Glargine, including repackagers and relabelers. The FDA regulates Glargine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Glargine 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 Glargine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Glargine supplier is an individual or a company that provides Glargine active pharmaceutical ingredient (API) or Glargine finished formulations upon request. The Glargine suppliers may include Glargine API manufacturers, exporters, distributors and traders.
click here to find a list of Glargine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Glargine DMF (Drug Master File) is a document detailing the whole manufacturing process of Glargine active pharmaceutical ingredient (API) in detail. Different forms of Glargine DMFs exist exist since differing nations have different regulations, such as Glargine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Glargine DMF submitted to regulatory agencies in the US is known as a USDMF. Glargine USDMF includes data on Glargine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Glargine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Glargine suppliers with USDMF on PharmaCompass.
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