01 1Alverine
02 1Benzimidazole
03 1Candesartan Cilexetil
04 1Carglumic Acid
05 1Carprofen
06 1Chloropyramine
07 1Clofedanol
08 1Dimiracetam
09 1Disopyramide
10 2Divalproex Sodium
11 1Efinaconazole
12 1Embutramide
13 1Fampridine
14 1Felbamate
15 1Gabapentin
16 1Guanfacine
17 1Iloperidone
18 1Isopropamide Iodide
19 1Istradefylline
20 2Labetalol Hydrochloride
21 1Landiolol Hydrochloride
22 1Levosulpiride
23 1Lofexidine
24 1Lurasidone Hydrochloride
25 1Memantine Hydrochloride
26 1Midostaurin
27 1Minodronic Acid
28 1Nafronyl Oxalate
29 1Naftopidil
30 1Nalfurafine
31 1Nimesulide
32 2Orphenadrine
33 1Orphenadrine Hydrochloride
34 1Phenelzine Sulfate
35 1Phenyltoloxamine Citrate
36 1Pirfenidone
37 1Pivagabine
38 1Prenylamine Lactate
39 1Proglumide
40 1Propafenone Hydrochloride
41 1Pyridostigmine
42 1Ranolazine
43 1Sivelestat Sodium Hydrate
44 1Terfenadine
45 1Thiaproline-M-Amino Benzoic Acid Hydrochloride
46 1Trospium Chloride
47 1Zonisamide
48 3Blank
01 21Active
02 19Inactive
03 13Blank
01 2Valid
02 51Blank
01 1217MF11129
02 1217MF11295
03 1218MF10992
04 1224MF10101
05 1225MF10161
06 1225MF10162
07 1227MF10007
08 1229MF10004
09 1229MF10035
10 1229MF10052
11 1304MF10033
12 1305MF10015
13 41Blank
01 53Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22902
Submission : 2009-06-25
Status : Active
Type : II
Registration Number : 217MF11129
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2005-12-05
Latest Date of Registration :
NDC Package Code : 46016-5112
Start Marketing Date : 2006-02-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-03-28
Pay. Date : 2017-12-15
DMF Number : 31933
Submission : 2017-11-15
Status : Active
Type : II
Registration Number : 305MF10015
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2023-02-02
Latest Date of Registration :
NDC Package Code : 46016-1642
Start Marketing Date : 2017-03-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-02-05
Registration Number : 133-12-ND
Manufacturer Name : Procos SpA
Manufacturer Address : Via Matteotti 249-28062 Cameri (NO) Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-24
Pay. Date : 2013-06-18
DMF Number : 10918
Submission : 1994-06-08
Status : Active
Type : II
Registration Number : 224MF10101
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2012-05-25
Latest Date of Registration :
NDC Package Code : 46016-0117
Start Marketing Date : 1994-06-08
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2016-06-03
Pay. Date : 2016-01-21
DMF Number : 26269
Submission : 2012-07-30
Status : Active
Type : II
Registration Number : 229MF10004
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2017-01-10
Latest Date of Registration :
NDC Package Code : 46016-4111
Start Marketing Date : 2012-07-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-10-05
Registration Number : 20211005-209-J-1116
Manufacturer Name : Procos SpA
Manufacturer Address : Via Matteotti, 249 - 28062 Cameri (NO), Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31815
Submission : 2017-07-31
Status : Active
Type : II
Certificate Number : R0-CEP 2020-073 - Rev 00
Issue Date : 2021-10-28
Type : Chemical
Substance Number : 2856
Status : Valid
NDC Package Code : 46016-5310
Start Marketing Date : 2015-10-27
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-06-24
Pay. Date : 2013-06-18
DMF Number : 11426
Submission : 1995-04-03
Status : Active
Type : II
Registration Number : 217MF11295
Registrant's Address : Via Matteotti 249,28062 CAMERI(NOVARA)/ITALY
Initial Date of Registration : 2005-12-22
Latest Date of Registration :
NDC Package Code : 46016-0320
Start Marketing Date : 2006-07-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-03-07
Pay. Date : 2013-02-19
DMF Number : 16035
Submission : 2002-06-26
Status : Active
Type : II
Certificate Number : CEP 2009-211 - Rev 01
Issue Date : 2023-11-17
Type : Chemical
Substance Number : 1255
Status : Valid
NDC Package Code : 46016-1012
Start Marketing Date : 2012-11-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-05-12
Registration Number : 20210512-211-J-632
Manufacturer Name : Procos SPA
Manufacturer Address : Viamatteotti 249, Cameri(Novara)28062 Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 227MF10007
Registrant's Address : Via Matteotti 249,28062 CAMERI (NOVARA)/ITALY
Initial Date of Registration : 2015-01-05
Latest Date of Registration :
Registrant Name : DKS Korea Co., Ltd.
Registration Date : 2021-03-12
Registration Number : 20210312-209-J-874
Manufacturer Name : Procos SpA@Dipharma Francis Srl
Manufacturer Address : Via Matteotti 249, Cameri, Novara 28062, Italy@33036, Via XXIV Maggio, 40, Mereto di Tomba (MI), Italy
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-01-03
Pay. Date : 2023-09-27
DMF Number : 38477
Submission : 2023-07-12
Status : Active
Type : II
NDC Package Code : 46016-1180
Start Marketing Date : 2019-05-13
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
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 : 11004
Submission : 1994-07-21
Status : Active
Type : II
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