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01 1Alivus Life Sciences
02 1Aurobindo Pharma Limited
03 1Dasami Lab
04 1Zydus Lifesciences
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01 4GABAPENTIN ENACARBIL
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01 4India
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01 4Active
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01 3Complete
02 1Blank
GDUFA
DMF Review : Complete
Rev. Date : 2018-11-21
Pay. Date : 2018-11-02
DMF Number : 33296
Submission : 2018-11-02
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-20
Pay. Date : 2023-11-29
DMF Number : 39197
Submission : 2023-12-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-05-10
Pay. Date : 2019-02-21
DMF Number : 33386
Submission : 2019-03-29
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41053
Submission : 2024-12-30
Status : Active
Type : II
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A (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid, including repackagers and relabelers. The FDA regulates (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid 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 (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid DMF (Drug Master File) is a document detailing the whole manufacturing process of (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid active pharmaceutical ingredient (API) in detail. Different forms of (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid DMFs exist exist since differing nations have different regulations, such as (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid DMF submitted to regulatory agencies in the US is known as a USDMF. (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid USDMF includes data on (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid USDMF is kept confidential to protect the manufacturer’s intellectual property.
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We have 4 companies offering (1-(((((1RS)-1-((2-methylpropanoyl)oxy)ethoxy)carbonyl)amino)methyl)cyclohexyl)acetic acid
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