CF Pharma- skilled & highly experienced European API producer based in Hungary.
01 1CF Pharma
02 1Akums Lifesciences
03 1Alembic Pharmaceuticals Limited
04 1Aragen Life Sciences
05 2BENE PHARMACHEM GMBH AND CO KG
06 1Micro Labs Limited
07 1Pioneer Pharma
08 1Swati Spentose
09 1Viatris
01 1ELMIRON (PENTOSAN POLYSULFATE SODIUM)CAPSULES 100MG, NJ
02 1PENTOSAN POLYFULFATE SODIUM
03 6PENTOSAN POLYSULFATE SODIUM
04 1PENTOSAN POLYSULFATE SODIUM (PPS), NON-STERILE BULK DRUG SUBSTANCE
05 1PENTOSAN POLYSULFATE SP54
01 2Germany
02 1Hungary
03 5India
04 1Iraq
05 1U.S.A
01 7Active
02 3Inactive
01 2Complete
02 8Blank
GDUFA
DMF Review : N/A
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DMF Number : 31045
Submission : 2016-10-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 25011
Submission : 2011-05-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 22582
Submission : 2009-02-20
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-11-12
Pay. Date : 2019-08-28
DMF Number : 34095
Submission : 2019-09-13
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 21248
Submission : 2008-01-10
Status : Active
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 4439
Submission : 1981-04-14
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-14
Pay. Date : 2023-05-24
DMF Number : 38294
Submission : 2023-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 8811
Submission : 1990-09-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25827
Submission : 2012-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31208
Submission : 2017-01-16
Status : Active
Type : II
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