Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
01 1Pfanstiehl
02 1ACS DOBFAR SPA
03 1AVT (Shanghai)
04 2Ajinomoto Company
05 2CordenPharma
06 1Hangzhou Think Chemical Co.Ltd
07 2Jing Jing Pharmaceutical
08 1Kyowa Hakko Bio
09 1Mitsubishi Tanabe Pharma
10 2Orchid Pharma
11 1Yangzhou Gami Biochem Co. Ltd
01 5China
02 2Germany
03 2India
04 1Italy
05 4Japan
06 1U.S.A
01 7Active
02 2Inactive
03 6Blank
01 1Valid
02 14Blank
01 1218MF10640
02 1218MF10702
03 13Blank
01 15Blank
Pfanstiehl, a global leader in the manufacture of cGMP high purity, low endotoxin, low metals (HPLE-LM)TM injectable grade excipients.
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-04
Pay. Date : 2020-11-30
DMF Number : 31646
Submission : 2017-04-20
Status : Active
Type : II
Certificate Number : R0-CEP 2022-190 - Rev 00
Issue Date : 2022-09-29
Type : Chemical
Substance Number : 806
Status : Valid
Registration Number : 218MF10640
Registrant's Address : 1-15-1 Kyobashi, Chuo-ku, Tokyo
Initial Date of Registration : 2006-07-20
Latest Date of Registration : --
NDC Package Code : 17333-002
Start Marketing Date : 2002-06-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39434
Submission : 2024-04-30
Status : Active
Type : IV
NDC Package Code : 17333-002
Start Marketing Date : 2002-06-28
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18843
Submission : 2005-10-07
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2021-08-09
Pay. Date : 2021-08-04
DMF Number : 18923
Submission : 2005-10-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39677
Submission : 2024-04-08
Status : Active
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22918
Submission : 2009-06-15
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-09-04
Pay. Date : 2014-05-23
DMF Number : 28191
Submission : 2014-05-15
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10131
Submission : 1989-04-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 1929
Submission : 1972-05-09
Status : Inactive
Type : II
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