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 1AMINO GmbH
03 1AVT (Shanghai)
04 5Ajinomoto Company
05 1Jing Jing Pharmaceutical
06 2Kyowa Hakko Bio
07 1Mitsubishi Tanabe Pharma
08 1Pcca
09 2SHANGHAI KYOWA AMINO ACID CO., LTD.
10 1Spectrum Chemical
11 1Summit Ingredients
12 1Synthelabo Tanabe Chimie
13 1Yangzhou Gami Biochem Co. Ltd
14 1Blank
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01 4China
02 1France
03 1Germany
04 10Japan
05 2U.S.A
06 1United Kingdom
07 1Blank
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01 4Active
02 2Inactive
03 14Blank
01 8Valid
02 12Blank
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01 1224MF10006
02 1224MF10011
03 1229MF10078
04 17Blank
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01 20Blank
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01 20Blank
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01 112497-1032
02 149452-3507
03 151495-381
04 151495-716
05 151495-816
06 151495-817
07 151495-916
08 151927-0308
09 174920-004
10 11Blank
01 20Blank
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 : 39086
Submission : 2023-11-30
Status : Active
Type : II
Certificate Number : R1-CEP 2016-114 - Rev 00
Issue Date : 2022-11-22
Type : Chemical
Substance Number : 911
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40314
Submission : 2024-09-18
Status : Active
Type : IV
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31562
Submission : 2017-03-21
Status : Active
Type : II
Certificate Number : R1-CEP 1998-107 - Rev 04
Issue Date : 2018-06-22
Type : Chemical
Substance Number : 911
Status : Valid
Registration Number : 224MF10006
Registrant's Address : 4020 Ajinomoto Drive Raleigh, North Carolina 27610, USA
Initial Date of Registration : 2012-01-18
Latest Date of Registration :
NDC Package Code : 51495-716
Start Marketing Date : 2022-10-01
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 : 39330
Submission : 2024-04-30
Status : Active
Type : IV
Certificate Number : R1-CEP 1998-121 - Rev 04
Issue Date : 2018-06-22
Type : Chemical
Substance Number : 910
Status : Valid
NDC Package Code : 51495-816
Start Marketing Date : 2022-10-01
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 : 5911
Submission : 1985-07-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1931
Submission : 1972-05-09
Status : Inactive
Type : II
Certificate Number : R1-CEP 2010-046 - Rev 01
Issue Date : 2017-04-28
Type : Chemical
Substance Number : 911
Status : Valid
NDC Package Code : 74920-004
Start Marketing Date : 2020-03-09
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Certificate Number : R1-CEP 1999-027 - Rev 04
Issue Date : 2022-05-20
Type : Chemical
Substance Number : 911
Status : Valid
Registration Number : 224MF10011
Registrant's Address : 1-6-1 Otemachi, Chiyoda-ku, Tokyo
Initial Date of Registration : 2012-01-18
Latest Date of Registration :
NDC Package Code : 12497-1032
Start Marketing Date : 1978-03-15
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Certificate Number : CEP 2014-269 - Rev 01
Issue Date : 2023-09-15
Type : Chemical
Substance Number : 911
Status : Valid
NDC Package Code : 51495-916
Start Marketing Date : 2022-10-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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