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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17186
Submission : 2004-02-26
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-07-25
Written Confirmation Number : WC-0159
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-05-24
Pay. Date : 2014-01-23
DMF Number : 21765
Submission : 2008-06-26
Status : Active
Type : II
NDC Package Code : 61662-0003
Start Marketing Date : 2017-11-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 22909
Submission : 2009-06-26
Status : Active
Type : II
NDC Package Code : 22568-8865
Start Marketing Date : 2021-06-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
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Rev. Date :
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DMF Number : 18898
Submission : 2005-10-08
Status : Inactive
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
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DMF Number : 9103
Submission : 1991-04-30
Status : Inactive
Type : II
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GDUFA
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Rev. Date :
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DMF Number : 22873
Submission : 2009-05-26
Status : Inactive
Type : II
A Amifostine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Amifostine, including repackagers and relabelers. The FDA regulates Amifostine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Amifostine 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 Amifostine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Amifostine supplier is an individual or a company that provides Amifostine active pharmaceutical ingredient (API) or Amifostine finished formulations upon request. The Amifostine suppliers may include Amifostine API manufacturers, exporters, distributors and traders.
click here to find a list of Amifostine suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
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