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01 1Alclometasone Dipropionate
02 1Alprostadil
03 2Beraprost Sodium
04 1Betamethasone
05 1Betamethasone Acetate
06 1Betamethasone Dipropionate
07 1Betamethasone Sodium Phosphate
08 1Betamethasone Valerate
09 1Bimatoprost
10 2Budesonide
11 1Ciclesonide
12 2Clobetasol Propionate
13 1Clobetasone Butyrate
14 1Cyproterone Acetate
15 1Deflazacort
16 1Desogestrel
17 1Desonide
18 3Dexamethasone
19 1Dexamethasone Sodium Phosphate
20 2Dienogest
21 2Drospirenone
22 1Estetrol
23 1Flumethasone Pivalate
24 1Fluocinolone Acetonide
25 1Fluocinonide
26 1Fluorometholone
27 1Fluticasone Furoate
28 1Fluticasone Propionate
29 1Gestodene
30 1Hydrocortisone
31 1Hydrocortisone Acetate
32 1Hydrocortisone Butyrate
33 1Hydrocortisone Sodium Succinate
34 1Iloprost
35 1Latanoprost
36 1Latanoprostene Bunod
37 1Limaprost Alfadex
38 1Loteprednol Etabonate
39 2Meprednisone
40 1Methylprednisolone Acetate
41 1Methylprednisolone Hemisuccinate
42 1Methylprednisolone Sodium Succinate
43 4Mometasone Furoate
44 1Myristyl-Gamma-Picolinium Chloride
45 1Nomegestrol Acetate
46 1Prednicarbate
47 1Prednisolone
48 1Prednisolone Sodium Phosphate
49 7Prednisolone Valerate Acetate
50 1Tibolone
51 1Travoprost
52 5Triamcinolone
53 8Triamcinolone Acetonide
54 1Ulipristal Acetate
55 1Blank
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01 19Active
02 5Inactive
03 59Blank
01 1Expired
02 20Valid
03 1Withdrawn by Holder
04 61Blank
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01 1217MF10601
02 1217MF11152
03 1218MF10277
04 1219MF10361
05 1223MF10022
06 1228MF10196
07 1229MF10222
08 1303MF10110
09 1304MF10120
10 1306MF10044
11 1306MF10159
12 1307MF10129
13 1308MF10013
14 70Blank
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01 83Blank
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01 120080829-65-B-249-04
02 120080829-65-B-249-04(1)
03 120080829-65-B-249-04(2)
04 120080829-65-B-249-04(3)
05 120080829-65-B-249-04(4)
06 120110315-65-B-311-05
07 120110315-65-B-311-05(1)
08 120110315-65-B-311-05(2)
09 120110315-65-B-311-05(3)
10 120110315-65-B-311-05(4)
11 120110315-65-B-311-05(5)
12 120110315-65-B-311-05(6)
13 120110315-65-B-311-05(7)
14 120111209-71-B-322-06
15 120111209-71-B-322-06(1)
16 120111209-71-B-322-06(2)
17 120111209-71-B-322-06(3)
18 120111209-71-B-322-06(5)
19 120111209-71-B-322-06(6)
20 120111209-71-B-322-06(7)
21 120200605-211-J-650
22 120210527-211-J-1001
23 120211206-209-J-1170
24 120220315-209-J-1249
25 120220328-209-J-1255
26 120220328-209-J-1255(1)
27 120240529-211-J-1610
28 1Number 437-1-ND(1)
29 1Su133-13-ND
30 1Su133-23-ND
31 1Su437-1-ND
32 52Blank
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01 124002-0001
02 124002-0002
03 124002-0003
04 124002-0004
05 124002-0005
06 124002-0006
07 124002-0007
08 124002-0010
09 124002-0011
10 124002-0012
11 124002-0013
12 124002-0014
13 124002-0015
14 124002-0016
15 124002-0017
16 124002-0019
17 124002-0021
18 124002-0024
19 124002-0025
20 124002-0026
21 124002-0028
22 124002-0029
23 124002-0030
24 124002-0031
25 124002-0033
26 124002-0034
27 124002-0035
28 124002-0036
29 124002-0037
30 124002-0038
31 124002-0039
32 52Blank
01 83Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-19
Pay. Date : 2013-09-03
DMF Number : 25319
Submission : 2011-08-22
Status : Active
Type : II
Certificate Number : R1-CEP 2009-185 - Rev 03
Issue Date : 2023-07-20
Type : Chemical
Substance Number : 1075
Status : Valid
Registration Number : 228MF10196
Registrant's Address : Via San Vittore, 39 - 20123 Milano (Italy)
Initial Date of Registration : 2016-10-17
Latest Date of Registration :
NDC Package Code : 24002-0001
Start Marketing Date : 2009-08-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2022-03-15
Registration Number : 20220315-209-J-1249
Manufacturer Name : Newchem SpA@MICROCHEM Srl
Manufacturer Address : Via Roveggia, 47-37136 Verona (VR), Italy@Via Turati, 2 – 29017 Fiorenzuola d'Arda (PC), Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42116
Submission : 2025-07-08
Status : Active
Type : II
Certificate Number : CEP 2016-155 - Rev 01
Issue Date : 2023-10-13
Type : Chemical
Substance Number : 2732
Status : Valid
Registration Number : 306MF10159
Registrant's Address : Via San Vittore, 39 - 20123 Milano (Italy)
Initial Date of Registration : 2024-12-18
Latest Date of Registration :
NDC Package Code : 24002-0034
Start Marketing Date : 2020-04-09
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-05-24
Registration Number : Number 437-1-ND(1)
Manufacturer Name : NEWCHEM SpA@Microchem Srl
Manufacturer Address : Via Roveggia, 47-37136 VERONA (VR), Italy@Via Turati, 2-29017 Fiorenzuola D'arda (PC), Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-04
Pay. Date : 2012-11-27
DMF Number : 22802
Submission : 2009-05-15
Status : Active
Type : II
Certificate Number : R0-CEP 2021-370 - Rev 01
Issue Date : 2023-07-21
Type : Chemical
Substance Number : 2404
Status : Valid
Registration Number : 306MF10044
Registrant's Address : Via San Vittore, 39 - 20123 Milano (Italy)
Initial Date of Registration : 2024-03-21
Latest Date of Registration :
NDC Package Code : 24002-0037
Start Marketing Date : 2021-12-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-03-12
Registration Number : Su133-13-ND
Manufacturer Name : NEWCHEM SpA@Microchem SRL
Manufacturer Address : Via Roveggia, 47, 37136 VERONA (VR), Italy@Via Turati, 2, 29017 Fiorenzuola d'Arda (PC) Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39550
Submission : 2024-05-23
Status : Active
Type : II
Certificate Number : R0-CEP 2020-368 - Rev 02
Issue Date : 2023-07-21
Type : Chemical
Substance Number : 2230
Status : Valid
Registration Number : 229MF10222
Registrant's Address : Via de Amicis 47, 20123 Milano, Italy
Initial Date of Registration : 2017-12-25
Latest Date of Registration :
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2024-05-29
Registration Number : 20240529-211-J-1610
Manufacturer Name : NEWCHEM SPA
Manufacturer Address : Via Parco del Ticino, 10-27100 San Martino Siccomario-Pavia Italy

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 42289
Submission : 2025-08-05
Status : Active
Type : II
Certificate Number : CEP 2021-060 - Rev 03
Issue Date : 2025-01-03
Type : Chemical
Substance Number : 2703
Status : Valid
NDC Package Code : 24002-0016
Start Marketing Date : 2009-08-11
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2022-04-07
Pay. Date : 2022-01-25
DMF Number : 36709
Submission : 2022-01-26
Status : Active
Type : II
Certificate Number : R1-CEP 2015-247 - Rev 01
Issue Date : 2023-08-01
Type : Chemical
Substance Number : 2404
Status : Valid
NDC Package Code : 24002-0002
Start Marketing Date : 2009-08-10
End Marketing Date : 2026-12-31
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 : 41935
Submission : 2025-06-13
Status : Active
Type : II
Registration Number : 308MF10013
Registrant's Address : Via San Vittore, 39 - 20123 Milano (Italy)
Initial Date of Registration : 2026-01-08
Latest Date of Registration :

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 22236
Submission : 2008-11-21
Status : Active
Type : II
Certificate Number : R1-CEP 2006-093 - Rev 05
Issue Date : 2023-07-19
Type : Chemical
Substance Number : 1750
Status : Valid
NDC Package Code : 24002-0003
Start Marketing Date : 2009-08-10
End Marketing Date : 2026-12-31
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 : 22575
Submission : 2009-02-26
Status : Active
Type : II
Certificate Number : R1-CEP 2005-185 - Rev 07
Issue Date : 2023-07-19
Type : Chemical
Substance Number : 1131
Status : Valid
NDC Package Code : 24002-0015
Start Marketing Date : 2009-08-17
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
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 : 21993
Submission : 2008-09-15
Status : Active
Type : II
Certificate Number : CEP 2024-348 - Rev 01
Issue Date : 2025-10-22
Type : Chemical
Substance Number : 2858
Status : Valid
NDC Package Code : 24002-0004
Start Marketing Date : 2009-08-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

Newchem Spa is a supplier offers 63 products (APIs, Excipients or Intermediates).
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