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 2Guanfacine
22 2Iloperidone
23 1Isopropamide Iodide
24 2Istradefylline
25 2Labetalol Hydrochloride
26 1Landiolol Hydrochloride
27 1Levosulpiride
28 1Lofexidine
29 1Lotamilast
30 2Lurasidone Hydrochloride
31 2Maropitant
32 2Memantine Hydrochloride
33 1Midostaurin
34 1Minodronic Acid
35 2N-Methyl Amisulpride
36 2Nafronyl Oxalate
37 1Naftopidil
38 1Nalfurafine
39 1Nimesulide
40 2Orphenadrine
41 1Orphenadrine Hydrochloride
42 1Phenelzine Sulfate
43 1Phenyltoloxamine Citrate
44 2Pirfenidone
45 1Pivagabine
46 1Prenylamine Lactate
47 1Proglumide
48 2Propafenone Hydrochloride
49 1Pyridostigmine
50 1Ranolazine
51 1Rimegepant Sulfate
52 1Sivelestat Sodium Hydrate
53 1Terfenadine
54 1Thiaproline-M-Amino Benzoic Acid Hydrochloride
55 1Tipiracil Hydrochloride
56 2Trospium Chloride
57 1Zonisamide
58 5Blank
01 21Active
02 19Inactive
03 40Blank
01 2Valid
02 78Blank
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 68Blank
01 80Blank
01 1133-12-ND
02 120201207-211-J-574
03 120201207-211-J-574(1)
04 120201207-211-J-574(2)
05 120210312-209-J-874
06 120210323-211-J-895
07 120210323-211-J-895(1)
08 120210512-211-J-632
09 120211005-209-J-1116
10 120211015-209-J-1015
11 1No. 133-8-ND(1)
12 1Su133-8-ND
13 68Blank
01 146016-0117
02 146016-0140
03 146016-0320
04 146016-0321
05 146016-0500
06 146016-1012
07 146016-1041
08 146016-1042
09 146016-1180
10 146016-1200
11 146016-1331
12 146016-1332
13 146016-1370
14 146016-1390
15 146016-1550
16 146016-1551
17 146016-1562
18 146016-1642
19 146016-1830
20 146016-2030
21 146016-2140
22 146016-2220
23 146016-2541
24 146016-2542
25 146016-2911
26 146016-2912
27 146016-3671
28 146016-3672
29 146016-4111
30 146016-4112
31 146016-5041
32 146016-5042
33 146016-5112
34 146016-5310
35 146016-5312
36 146016-5450
37 146016-6400
38 146016-7940
39 146016-9470
40 146016-9522
41 40Blank
01 15625
02 16371
03 16372
04 77Blank
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 : 2025-12-31
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 : 2025-12-31
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 : 2025-12-31
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 : 2025-12-31
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 : 46016-5312
Start Marketing Date : 2020-02-06
End Marketing Date : 2025-12-31
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 : 2025-12-31
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 : 2025-12-31
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 : 2025-12-31
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 :
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DMF Number : 11004
Submission : 1994-07-21
Status : Active
Type : II
