01 1Aurobindo Pharma Limited
02 1Dasami Lab
03 1Glenmark Life Sciences
04 1Zydus Lifesciences
01 4GABAPENTIN ENACARBIL
01 4India
01 4Active
01 3Complete
02 1Blank
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 : 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 : 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 Gabapentin Enacarbil manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Gabapentin Enacarbil, including repackagers and relabelers. The FDA regulates Gabapentin Enacarbil manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Gabapentin Enacarbil 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 Gabapentin Enacarbil supplier is an individual or a company that provides Gabapentin Enacarbil active pharmaceutical ingredient (API) or Gabapentin Enacarbil finished formulations upon request. The Gabapentin Enacarbil suppliers may include Gabapentin Enacarbil API manufacturers, exporters, distributors and traders.
click here to find a list of Gabapentin Enacarbil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Gabapentin Enacarbil DMF (Drug Master File) is a document detailing the whole manufacturing process of Gabapentin Enacarbil active pharmaceutical ingredient (API) in detail. Different forms of Gabapentin Enacarbil DMFs exist exist since differing nations have different regulations, such as Gabapentin Enacarbil USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Gabapentin Enacarbil DMF submitted to regulatory agencies in the US is known as a USDMF. Gabapentin Enacarbil USDMF includes data on Gabapentin Enacarbil's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gabapentin Enacarbil USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Gabapentin Enacarbil suppliers with USDMF on PharmaCompass.
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