Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1AMINO GmbH
03 1AVT (Shanghai)
04 3Ajinomoto Company
05 2Antibioticos do Brasil Ltda
06 1CordenPharma
07 1Fresenius Kabi AB Brunna
08 1Hangzhou Think Chemical Co.Ltd
09 1Jing Jing Pharmaceutical
10 2Kyowa Hakko Bio
11 1Mitsubishi Tanabe Pharma
12 1Rexim SAS
13 2SHANGHAI KYOWA AMINO ACID CO., LTD.
14 2SIGMA TAU
15 1Sandoz B2B
16 1Summit Ingredients
17 1Yangzhou Gami Biochem Co. Ltd
01 2Brazil
02 5China
03 1France
04 2Germany
05 8Japan
06 1Sweden
07 1Switzerland
08 3U.S.A
01 5Active
02 8Inactive
03 10Blank
01 8Valid
02 1Withdrawn by Holder
03 14Blank
01 1218MF10637
02 1219MF10190
03 21Blank
01 23Blank
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 :
Pay. Date :
DMF Number : 19655
Submission : 2006-08-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 28258
Submission : 2014-02-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38726
Submission : 2024-01-15
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21572
Submission : 2008-02-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8753
Submission : 1990-09-18
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9979
Submission : 1992-11-19
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1274
Submission : 1968-12-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 2170
Submission : 1973-10-24
Status : Inactive
Type : II
Certificate Number : R1-CEP 1999-028 - Rev 04
Issue Date : 2022-06-20
Type : Chemical
Substance Number : 805
Status : Valid
Registration Number : 219MF10190
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2007-06-08
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 748
Submission : 1963-12-10
Status : Inactive
Type : II
Certificate Number : R0-CEP 2022-189 - Rev 00
Issue Date : 2022-09-28
Type : Chemical
Substance Number : 805
Status : Valid
Registration Number : 218MF10637
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2006-07-20
Latest Date of Registration : --
NDC Package Code : 17333-004
Start Marketing Date : 2002-06-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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