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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01 1Pfanstiehl
02 1Anlon Healthcare Ltd
03 1AMINO GmbH
04 1AVT (Shanghai)
05 3Ajinomoto Company
06 2Antibioticos do Brasil Ltda
07 1CordenPharma
08 1Fresenius Kabi AB Brunna
09 1Hangzhou Think Chemical Co.Ltd
10 1Hubei Gedian Humanwell Pharmaceutical
11 1Jing Jing Pharmaceutical
12 2Kyowa Hakko Bio
13 1Mitsubishi Tanabe Pharma
14 1Rexim SAS
15 2SIGMA TAU
16 1Sandoz B2B
17 1Summit Ingredients
18 1Tianjin Tianfa Pharmaceutical Import & Export
19 1Yangzhou Gami Biochem Co. Ltd
20 1Yichang Sanxia Pharmaceutical
21 2Blank
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01 2Brazil
02 8China
03 1France
04 2Germany
05 1India
06 6Japan
07 1Sweden
08 1Switzerland
09 3U.S.A
10 2Blank
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01 6Active
02 8Inactive
03 13Blank
01 8Valid
02 1Withdrawn by Holder
03 18Blank
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01 1218MF10637
02 1219MF10190
03 25Blank
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01 27Blank
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01 117333-004
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Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
Anlon Healthcare manufactures high-quality Pharmaceutical Bulk Drugs & Intermediates compliant with FDA, PMDA, KFDA, cGMP & WHO-GMP.
GDUFA
DMF Review : N/A
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DMF Number : 38726
Submission : 2024-01-15
Status : Active
Type : IV

GDUFA
DMF Review : N/A
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DMF Number : 42462
Submission : 2025-12-25
Status : Active
Type : IV

GDUFA
DMF Review : N/A
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DMF Number : 19655
Submission : 2006-08-03
Status : Active
Type : II

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DMF Review : N/A
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DMF Number : 1274
Submission : 1968-12-31
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
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DMF Number : 28650
Submission : 2014-10-23
Status : Inactive
Type : IV

GDUFA
DMF Review : N/A
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DMF Number : 8753
Submission : 1990-09-18
Status : Inactive
Type : II

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DMF Number : 9979
Submission : 1992-11-19
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
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DMF Number : 21572
Submission : 2008-02-13
Status : Inactive
Type : II

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