Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
01 1Aarti Pharmalabs
02 1Baxter Healthcare Corporation
03 1IFOTAM
04 1Jiangsu Hengrui Medicine
05 1Blank
01 2IFOSFAMIDE
02 1IFOSFAMIDE CRUDE
03 1IFOSFAMIDE USP, NON-STERILE, BULK DRUG SUBSTANCE
04 1IFOSFAMIDE USP/EP
01 1China
02 1India
03 1Poland
04 1U.S.A
05 1Blank
01 4Active
02 1Inactive
01 1Complete
02 4Blank
Aarti Pharmalabs is a partner of choice for APIs & Intermediates and the largest Indian manufacturer of Xanthine Derivatives.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25081
Submission : 2009-07-20
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3506
Submission : 1979-04-24
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15064
Submission : 2000-09-29
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2015-09-04
Pay. Date : 2015-08-18
DMF Number : 11290
Submission : 1995-01-11
Status : Active
Type : II
USDMF
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14796
Submission : 2000-03-28
Status : Inactive
Type : II
Portfolio PDF
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A Ifex manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ifex, including repackagers and relabelers. The FDA regulates Ifex manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ifex 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 Ifex DMF (Drug Master File) is a document detailing the whole manufacturing process of Ifex active pharmaceutical ingredient (API) in detail. Different forms of Ifex DMFs exist exist since differing nations have different regulations, such as Ifex USDMF, ASMF (EDMF), JDMF, CDMF, etc.
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