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02 1Alkem Laboratories
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01 1WC-0168
02 1WC-0370n
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-03
Pay. Date : 2013-11-12
DMF Number : 27623
Submission : 2013-10-18
Status : Active
Type : II
NDC Package Code : 63190-0510
Start Marketing Date : 2010-01-22
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-04
Pay. Date : 2013-12-20
DMF Number : 24718
Submission : 2011-03-21
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-24
Pay. Date : 2013-12-27
DMF Number : 27819
Submission : 2013-12-30
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4827
Submission : 1983-03-03
Status : Active
Type : II
NDC Package Code : 12817-054
Start Marketing Date : 1956-01-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (100kg/100kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-12-10
Pay. Date : 2018-09-28
DMF Number : 33146
Submission : 2018-09-27
Status : Active
Type : II
NDC Package Code : 42571-338
Start Marketing Date : 2019-07-02
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-24
Pay. Date : 2013-11-19
DMF Number : 27637
Submission : 2013-11-01
Status : Active
Type : II
Date of Issue : 2022-07-23
Valid Till : 2025-09-05
Written Confirmation Number : WC-0370n
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-05
Pay. Date : 2013-11-01
DMF Number : 27662
Submission : 2013-11-18
Status : Active
Type : II
Date of Issue : 2022-08-08
Valid Till : 2025-07-14
Written Confirmation Number : WC-0168
Address of the Firm :
NDC Package Code : 62756-038
Start Marketing Date : 2023-02-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-02-26
Pay. Date : 2014-01-06
DMF Number : 27843
Submission : 2014-01-09
Status : Active
Type : II
NDC Package Code : 65862-917
Start Marketing Date : 2024-01-08
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-03-26
Pay. Date : 2013-11-20
DMF Number : 27647
Submission : 2013-10-15
Status : Active
Type : II
NDC Package Code : 46016-5041
Start Marketing Date : 2011-11-07
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 : 3836
Submission : 1980-06-12
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25695
Submission : 2012-05-15
Status : Inactive
Type : II
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PharmaCompass offers a list of Dalfampridine 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 Dalfampridine manufacturer or Dalfampridine supplier for your needs.
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PharmaCompass also assists you with knowing the Dalfampridine API Price utilized in the formulation of products. Dalfampridine API Price is not always fixed or binding as the Dalfampridine Price is obtained through a variety of data sources. The Dalfampridine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Fampridine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Fampridine, including repackagers and relabelers. The FDA regulates Fampridine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Fampridine API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Fampridine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Fampridine supplier is an individual or a company that provides Fampridine active pharmaceutical ingredient (API) or Fampridine finished formulations upon request. The Fampridine suppliers may include Fampridine API manufacturers, exporters, distributors and traders.
click here to find a list of Fampridine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
We have 14 companies offering Fampridine
Get in contact with the supplier of your choice: