01 3Alverine
02 1Aminolevulinic Acid HCl
03 1Benzimidazole
04 1Candesartan Cilexetil
05 1Carglumic Acid
06 1Carprofen
07 1Chloropyramine
08 1Chlorzoxazone
09 1Clofazimine
10 1Clofedanol
11 1Delta-Aminolevulinic Acid Methyl Ester
12 1Dimiracetam
13 1Disopyramide
14 2Divalproex Sodium
15 1Efinaconazole
16 1Embutramide
17 1Ethacridine Lactate
18 2Fampridine
19 2Felbamate
20 1Gabapentin
21 1Guanfacine
22 2Iloperidone
23 1Imepitoin
24 1Isopropamide Iodide
25 2Istradefylline
26 2Labetalol Hydrochloride
27 1Landiolol Hydrochloride
28 1Levosulpiride
29 1Lofexidine
30 1Lotamilast
31 1Lotilaner
32 2Lurasidone Hydrochloride
33 2Maropitant
34 2Memantine Hydrochloride
35 1Midostaurin
36 1Minodronic Acid
37 1N-Methyl Amisulpride
38 2Nafronyl Oxalate
39 2Naftopidil
40 1Nalfurafine
41 1Nimesulide
42 2Orphenadrine
43 1Orphenadrine Hydrochloride
44 1Phenelzine Sulfate
45 1Phenyltoloxamine Citrate
46 1Pirfenidone
47 1Pivagabine
48 1Prenylamine Lactate
49 1Proglumide
50 2Propafenone Hydrochloride
51 1Pyridostigmine
52 1Ranolazine
53 1Rimegepant Sulfate
54 1Sivelestat Sodium Hydrate
55 1Terfenadine
56 1Thiaproline-M-Amino Benzoic Acid Hydrochloride
57 1Tipiracil Hydrochloride
58 2Trospium Chloride
59 1Zonisamide
60 3Blank
01 20Active
02 20Inactive
03 38Blank
01 2Valid
02 76Blank
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 66Blank
01 78Blank
01 120201207-211-J-574
02 120201207-211-J-574(1)
03 120201207-211-J-574(2)
04 120210312-209-J-874
05 120210323-211-J-895
06 120210323-211-J-895(1)
07 120210512-211-J-632
08 120211005-209-J-1116
09 120211015-209-J-1015
10 1Su133-12-ND
11 1Su133-8-ND
12 1Su133-8-ND(1)
13 66Blank
01 146016-0098
02 146016-0117
03 146016-0140
04 146016-0320
05 146016-0321
06 146016-0500
07 146016-1012
08 146016-1041
09 146016-1042
10 146016-1180
11 146016-1200
12 146016-1331
13 146016-1332
14 146016-1360
15 146016-1370
16 146016-1550
17 146016-1551
18 146016-1562
19 146016-1642
20 146016-1830
21 146016-1880
22 146016-2030
23 146016-2140
24 146016-2220
25 146016-2541
26 146016-2542
27 146016-2912
28 146016-3592
29 146016-3671
30 146016-3672
31 146016-4111
32 146016-4112
33 146016-5041
34 146016-5042
35 146016-5112
36 146016-5310
37 146016-5371
38 146016-5450
39 146016-6400
40 146016-7940
41 146016-9470
42 146016-9522
43 36Blank
01 15625
02 16371
03 16372
04 75Blank
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 : 2026-12-31
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 : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-02-05
Registration Number : Su133-12-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 : 2026-12-31
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 : 2026-12-31
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
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DMF Review : N/A
Rev. Date :
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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 : 2026-12-31
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 : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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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 : 2026-12-31
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 : DKSH 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 : 2026-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
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 : 11004
Submission : 1994-07-21
Status : Active
Type : II
NDC Package Code : 46016-0098
Start Marketing Date : 2006-07-01
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (50kg/50kg)
Marketing Category : BULK INGREDIENT
