SPI Pharma has been solving formulation challenges using superior functional materials.

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02 1Gangwal Healthcare
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04 1AVT (Shanghai)
05 1Agno Pharma
06 1Anmol Chemicals
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08 1Freund Vector Corporation
09 1HUNAN JIUDIAN PHARMACEUTICAL CO LTD
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11 1Kerry
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15 1Shandong Tianli Pharmaceutical Co ltd
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16037
Submission : 2002-07-03
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41204
Submission : 2025-01-15
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
Rev. Date :
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DMF Number : 32464
Submission : 2018-02-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17044
Submission : 2003-12-22
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 24099
Submission : 2010-08-27
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28402
Submission : 2014-06-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39035
Submission : 2023-10-27
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41812
Submission : 2025-07-25
Status : Active
Type : IV

GDUFA
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Rev. Date :
Pay. Date :
DMF Number : 41483
Submission : 2025-03-21
Status : Active
Type : IV

GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 27343
Submission : 2013-07-25
Status : Inactive
Type : IV

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