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 1Jing Jing Pharmaceutical
06 2Kyowa Hakko Bio
07 1Mitsubishi Tanabe Pharma
08 2SHANGHAI KYOWA AMINO ACID CO., LTD.
09 1Summit Ingredients
10 1Synthelabo Tanabe Chimie
11 1Yangzhou Gami Biochem Co. Ltd
12 1Blank
01 4China
02 1France
03 1Germany
04 8Japan
05 1U.S.A
06 1Blank
01 4Active
02 2Inactive
03 10Blank
01 8Valid
02 8Blank
01 1224MF10006
02 1224MF10011
03 1229MF10078
04 13Blank
01 16Blank
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 : Reviewed
Rev. Date : 2021-08-27
Pay. Date : 2020-11-30
DMF Number : 31562
Submission : 2017-03-21
Status : Active
Type : II
Certificate Number : CEP 2014-269 - Rev 01
Issue Date : 2023-09-15
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 : 51495-381
Start Marketing Date : 2022-09-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1.26kg/100kg 10.64kg/100kg 17.13kg/100kg 3.27kg/100kg 6.73kg/100kg 9.27kg/100kg .7kg/100kg 11kg/100kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39330
Submission : 2024-04-30
Status : Active
Type : IV
Certificate Number : R1-CEP 1998-107 - Rev 04
Issue Date : 2018-06-22
Type : Chemical
Substance Number : 911
Status : Valid
NDC Package Code : 51495-381
Start Marketing Date : 2022-09-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1.26kg/100kg 10.64kg/100kg 17.13kg/100kg 3.27kg/100kg 6.73kg/100kg 9.27kg/100kg .7kg/100kg 11kg/100kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40314
Submission : 2024-09-18
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1931
Submission : 1972-05-09
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5911
Submission : 1985-07-05
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-121 - Rev 04
Issue Date : 2018-06-22
Type : Chemical
Substance Number : 910
Status : Valid
NDC Package Code : 51495-381
Start Marketing Date : 2022-09-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1.26kg/100kg 10.64kg/100kg 17.13kg/100kg 3.27kg/100kg 6.73kg/100kg 9.27kg/100kg .7kg/100kg 11kg/100kg)
Marketing Category : DRUG FOR FURTHER PROCESSING
Certificate Number : R1-CEP 2010-047 - Rev 01
Issue Date : 2017-06-01
Type : Chemical
Substance Number : 910
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
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