SPI Pharma has been solving formulation challenges using superior functional materials.
01 4SPI Pharma
02 1Pfanstiehl
03 1Anmol Chemicals
04 1BASF
05 1Cargill, Incorporated
06 1Freund Vector Corporation
07 1Kerry
08 3Roquette
09 1S D Fine Chem Limited
10 1Shandong Tianli Pharmaceutical Co ltd
11 1Viatris
12 1Westpoint pharma
01 15Active
02 1Inactive
03 1Blank
01 3Valid
02 14Blank
01 17Blank
01 17Blank
GDUFA
DMF Review : N/A
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DMF Number : 16037
Submission : 2002-07-03
Status : Active
Type : IV
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : N/A
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DMF Number : 32464
Submission : 2018-02-15
Status : Active
Type : IV
GDUFA
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DMF Number : 17044
Submission : 2003-12-22
Status : Active
Type : IV
GDUFA
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DMF Number : 24099
Submission : 2010-08-27
Status : Active
Type : IV
GDUFA
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DMF Number : 28402
Submission : 2014-06-18
Status : Active
Type : IV
GDUFA
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DMF Number : 28717
Submission : 2014-10-03
Status : Active
Type : IV
GDUFA
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DMF Number : 39035
Submission : 2023-10-27
Status : Active
Type : II
GDUFA
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DMF Number : 14891
Submission : 2000-05-16
Status : Active
Type : IV
Certificate Number : R1-CEP 2000-039 - Rev 01
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559
Status : Valid
NDC Package Code : 50516-002
Start Marketing Date : 2014-05-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 39456
Submission : 2024-02-06
Status : Active
Type : IV
GDUFA
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DMF Number : 18143
Submission : 2005-03-08
Status : Active
Type : IV
Certificate Number : R1-CEP 2000-040 - Rev 02
Issue Date : 2019-09-12
Type : Chemical
Substance Number : 559
Status : Valid
NDC Package Code : 50516-002
Start Marketing Date : 2014-05-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
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DMF Number : 23720
Submission : 2010-04-16
Status : Active
Type : IV
NDC Package Code : 50516-002
Start Marketing Date : 2014-05-07
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39756
Submission : 2024-03-27
Status : Active
Type : IV
GDUFA
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DMF Number : 38630
Submission : 2023-08-21
Status : Active
Type : IV
GDUFA
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DMF Number : 20960
Submission : 2007-10-11
Status : Active
Type : IV
GDUFA
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DMF Number : 19954
Submission : 2006-10-30
Status : Active
Type : IV
GDUFA
DMF Review : N/A
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DMF Number : 27343
Submission : 2013-07-25
Status : Inactive
Type : IV
Certificate Number : R1-CEP 2005-019 - Rev 02
Issue Date : 2019-09-04
Type : Chemical
Substance Number : 559
Status : Valid
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