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