01 1Ahk Tech
02 1Axitec
03 1Grace
04 1Lianyungang Runzhong Pharmaceutical Co Ltd
05 1Sun Pharmaceutical Industries Limited
06 1Blank
01 4AMIFOSTINE
02 1AMIFOSTINE USP
03 1AMIFOSTINE USP (NON-STERILE BULK DRUG)
01 3China
02 1India
03 1U.S.A
04 1Blank
01 3Active
02 3Inactive
01 1Complete
02 5Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22873
Submission : 2009-05-26
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18898
Submission : 2005-10-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22909
Submission : 2009-06-26
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-24
Pay. Date : 2014-01-23
DMF Number : 21765
Submission : 2008-06-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17186
Submission : 2004-02-26
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9103
Submission : 1991-04-30
Status : Inactive
Type : II
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Corporate PDF
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.
A Amifostine DMF (Drug Master File) is a document detailing the whole manufacturing process of Amifostine active pharmaceutical ingredient (API) in detail. Different forms of Amifostine DMFs exist exist since differing nations have different regulations, such as Amifostine USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Amifostine DMF submitted to regulatory agencies in the US is known as a USDMF. Amifostine USDMF includes data on Amifostine's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amifostine USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Amifostine suppliers with USDMF on PharmaCompass.
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