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02 1Gangwal Healthcare
03 1Pfanstiehl
04 1AVT (Shanghai)
05 1Agno Pharma
06 1Anmol Chemicals
07 1BASF
08 1Freund Vector Corporation
09 1HUNAN JIUDIAN PHARMACEUTICAL CO LTD
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15 2Sterile India Pvt. Ltd
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01 149574-527
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GDUFA
DMF Review : N/A
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DMF Number : 16037
Submission : 2002-07-03
Status : Active
Type : IV
GDUFA
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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.
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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
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DMF Number : 24099
Submission : 2010-08-27
Status : Active
Type : IV
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DMF Number : 28402
Submission : 2014-06-18
Status : Active
Type : IV
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DMF Number : 39035
Submission : 2023-10-27
Status : Active
Type : II
GDUFA
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DMF Number : 41483
Submission : 2025-03-21
Status : Active
Type : IV
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DMF Number : 20960
Submission : 2007-10-11
Status : Active
Type : IV
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DMF Number : 27343
Submission : 2013-07-25
Status : Inactive
Type : IV
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