01 11H-Imidazole-4-Carboxamide, 5-Amino-, Monohydrochloride
02 2Alendronate Sodium
03 1Benserazide Hydrochloride
04 1Bupropion Hydrobromide
05 2Bupropion Hydrochloride
06 1Diarachidonyl Phosphatidylcholine
07 1Diflunisal
08 2Dimyristoyl Lecithin
09 1Dimyristoylphosphatidylglycerol
10 1Eptifibatide
11 1Etodolac
12 1Fesoterodine
13 1Flunarizine
14 1Givinostat
15 1Goserelin Acetate
16 1Hydroxyzine Dihydrochloride
17 1Hydroxyzine Pamoate
18 1Ibandronate Sodium
19 1Indomethacin
20 1Leuprolide Acetate
21 3Mesalazine
22 1Miconazole
23 1Miconazole Nitrate
24 1Nabumetone
25 1Octreotide Acetate
26 1Oxiracetam
27 1POPC
28 2POPG
29 1Paroxetine Hydrochloride
30 1Water
31 1Ypo0Ntk49O
32 1Zoledronic Acid
33 5Blank
01 11Active
02 29Inactive
03 3Blank
01 6Valid
02 2Withdrawn by Holder
03 35Blank
01 1219MF10131
02 1224MF10109
03 1224MF10177
04 1225MF10022
05 1226MF10055
06 38Blank
01 43Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-20
Pay. Date : 2013-01-11
DMF Number : 14763
Submission : 2000-03-07
Status : Active
Type : II
Certificate Number : R1-CEP 2008-115 - Rev 04
Issue Date : 2022-03-10
Type : Chemical
Substance Number : 1442
Status : Valid
Registration Number : 224MF10177
Registrant's Address : Via dei Laboratori 54, 20092 Cinisello Balsamo (Milano), ITALY
Initial Date of Registration : 2012-08-17
Latest Date of Registration :
NDC Package Code : 54127-9002
Start Marketing Date : 2000-03-07
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9454
Submission : 1991-12-09
Status : Inactive
Type : II
Certificate Number : R1-CEP 2008-046 - Rev 03
Issue Date : 2020-03-17
Type : Chemical
Substance Number : 1699
Status : Valid
Registration Number : 219MF10131
Registrant's Address : Via dei Laboratori 54, 20092 Cinisello Balsamo (Milano), ITALY
Initial Date of Registration : 2007-04-18
Latest Date of Registration :
NDC Package Code : 54127-0943
Start Marketing Date : 1996-04-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-05-09
Registration Number : 20230509-209-J-1430
Manufacturer Name : Chemi SpA
Manufacturer Address : Via Vadisi, 5-03010 Patrica (Frosinone) Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-27
Pay. Date : 2012-11-19
DMF Number : 11951
Submission : 1996-04-29
Status : Active
Type : II
Certificate Number : R1-CEP 2003-188 - Rev 06
Issue Date : 2020-03-31
Type : Chemical
Substance Number : 1699
Status : Valid
NDC Package Code : 54127-0943
Start Marketing Date : 1996-04-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2023-05-09
Registration Number : 20230509-209-J-1430
Manufacturer Name : Chemi SpA
Manufacturer Address : Via Vadisi, 5-03010 Patrica (Frosinone) Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 12296
Submission : 1996-12-23
Status : Inactive
Type : II
Certificate Number : R1-CEP 2007-002 - Rev 01
Issue Date : 2014-03-10
Type : Chemical
Substance Number : 1350
Status : Withdrawn by Holder
Registration Number : 224MF10109
Registrant's Address : Viale dei Laboratori 54, 20092 Cinisello Balsamo (Milano), Italy
Initial Date of Registration : 2012-06-22
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 19567
Submission : 2006-06-28
Status : Active
Type : II
Registration Number : 226MF10055
Registrant's Address : Viale dei Laboratori 54, 20092 Cinisello Balsamo (Milano) ITALY
Initial Date of Registration : 2014-03-06
Latest Date of Registration :
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DMF Review : N/A
Rev. Date :
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DMF Number : 25983
Submission : 2012-04-19
Status : Inactive
Type : II
Registration Number : 225MF10022
Registrant's Address : Viale dei Laboratori 54, 20092 Cinisello Balsamo (Milano), Italy
Initial Date of Registration : 2013-02-06
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 14013
Submission : 1999-03-05
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Certificate Number : CEP 2021-226 - Rev 01
Issue Date : 2024-03-13
Type : Chemical
Substance Number : 1173
Status : Valid
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 18922
Submission : 2005-10-27
Status : Active
Type : II
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
Rev. Date :
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DMF Number : 11834
Submission : 1996-01-29
Status : Active
Type : II
Italfarmaco S.p.a is a supplier offers 1 products (APIs, Excipients or Intermediates).
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