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01 1Atman Pharmaceuticals
02 1Aurobindo Pharma Limited
03 1Dasami Lab
04 1Glenmark Life Sciences
05 1Glenmark Pharmaceuticals
06 1Hetero Drugs
07 1Maithri Drugs
08 1Maps Laboratories Private Limited
09 1Rakshit Drugs
10 1Zhejiang Bamboo Pharmaceuticals
11 1Zydus Lifesciences
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01 1China
02 10India
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01 1WC-0310
02 1WC-0331
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GDUFA
DMF Review : Reviewed
Rev. Date : 2019-05-10
Pay. Date : 2019-02-21
DMF Number : 33386
Submission : 2019-03-29
Status : Active
Type : II
NDC Package Code : 70966-0011
Start Marketing Date : 2011-12-13
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-11-21
Pay. Date : 2018-11-02
DMF Number : 33296
Submission : 2018-11-02
Status : Active
Type : II
Date of Issue : 2023-12-28
Valid Till : 2026-12-28
Written Confirmation Number : WC-0310
Address of the Firm :
NDC Package Code : 66039-945
Start Marketing Date : 2018-11-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-12-20
Pay. Date : 2023-11-29
DMF Number : 39197
Submission : 2023-12-01
Status : Active
Type : II
NDC Package Code : 59651-882
Start Marketing Date : 2023-11-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41053
Submission : 2024-12-30
Status : Active
Type : II
Date of Issue : 2022-04-04
Valid Till : 2025-01-13
Written Confirmation Number : WC-0331
Address of the Firm :
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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click here to find a list of Gabapentin Enacarbil suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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