01 1Alivus Life Sciences
02 1Aurobindo Pharma Limited
03 1Dasami Lab
04 1Zydus Lifesciences
01 4GABAPENTIN ENACARBIL
01 4India
01 4Active
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
34
PharmaCompass offers a list of Gabapentin Enacarbil 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 Gabapentin Enacarbil manufacturer or Gabapentin Enacarbil supplier for your needs.
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A gabapentinum enacarbilum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of gabapentinum enacarbilum, including repackagers and relabelers. The FDA regulates gabapentinum enacarbilum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. gabapentinum enacarbilum 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 gabapentinum enacarbilum supplier is an individual or a company that provides gabapentinum enacarbilum active pharmaceutical ingredient (API) or gabapentinum enacarbilum finished formulations upon request. The gabapentinum enacarbilum suppliers may include gabapentinum enacarbilum API manufacturers, exporters, distributors and traders.
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A gabapentinum enacarbilum DMF (Drug Master File) is a document detailing the whole manufacturing process of gabapentinum enacarbilum active pharmaceutical ingredient (API) in detail. Different forms of gabapentinum enacarbilum DMFs exist exist since differing nations have different regulations, such as gabapentinum enacarbilum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A gabapentinum enacarbilum DMF submitted to regulatory agencies in the US is known as a USDMF. gabapentinum enacarbilum USDMF includes data on gabapentinum enacarbilum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The gabapentinum enacarbilum USDMF is kept confidential to protect the manufacturer’s intellectual property.
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