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01 1Atman Pharma Private Limited
02 1Alivus Life Sciences
03 1Aurobindo Pharma Limited
04 1Dasami Lab
05 1Glenmark Pharmaceuticals
06 1Hetero Drugs
07 1Lonza Inc & Lonza America Inc
08 1Maithri Drugs
09 1Maps Laboratories Private Limited
10 1Zhejiang Bamboo Pharmaceuticals
11 1Zydus Lifesciences
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01 1China
02 9India
03 1U.S.A
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01 1WC-0310
02 1WC-0331A2
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01 149187-0710
02 159651-882
03 166039-945
04 170966-0011
05 181999-0014
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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 : 2025-12-31
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
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 : 2023-11-28
Valid Till : 2026-11-28
Written Confirmation Number : WC-0310
Address of the Firm :
NDC Package Code : 66039-945
Start Marketing Date : 2018-11-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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
NDC Package Code : 81999-0014
Start Marketing Date : 2025-01-20
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2022-04-04
Valid Till : 2025-01-13
Written Confirmation Number : WC-0331A2
Address of the Firm :
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.
click here to find a list of gabapentinum enacarbilum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 11 companies offering gabapentinum enacarbilum
Get in contact with the supplier of your choice: