01 14-Biphenylacetic Acid
02 1Amrubicin
03 1Baclofen
04 3Bezafibrate
05 1Bicalutamide
06 1Bilastine
07 1Bovine Serum
08 1Cefpiramide
09 1Citalopram Hydrobromide
10 1Crotamiton
11 1Dipivefrin Hydrochloride
12 3Disopyramide
13 1Droxidopa
14 1Enoxacin
15 1Fexofenadine Hydrochloride
16 1Fidaresstat
17 1Genaconazole
18 1Glipizide
19 1Hydralazine
20 1Hydralazine Hydrochloride
21 1Imatinib Mesylate
22 1Ipriflavone
23 1Ketosulfone
24 1Lacosamide
25 1Lanthanum Carbonate
26 1Levobunolol
27 1Lurasidone Hydrochloride
28 1Mequitazine
29 3Meropenem
30 1Metaqualone
31 1Milnacipran Hydrochloride
32 1Mirtazapine
33 1Netoglitazone
34 1Olmesartan Medoxomil
35 2Olopatadine Hydrochloride
36 1Orbifloxacin
37 1Oteracil Potassium
38 1Oxaprozin
39 1Paroxetine Hydrochloride
40 1Phenethicillin Potassium
41 1Phenothrin
42 1Prazosin Hydrochloride
43 1Pregabalin
44 1Probucol
45 1Propylthiouracil
46 1Quetiapine Hemifumarate
47 1Ranirestat
48 1Rimacalib
49 1Rivaroxaban
50 1Sb 210232
51 1Sm-216601
52 1Smp 797
53 1Sodium Valproate
54 1Sparfloxacin
55 1Telmisartan
56 1Terazosin HCl
57 1Thiazole
58 1Timolol Maleate
59 1Trientine Hydrochloride
60 2Tulobuterol
61 3Valsartan
62 1Zonisamide
63 15Blank
01 5Active
02 43Inactive
03 39Blank
01 2Valid
02 85Blank
01 1217MF10074
02 1217MF10075
03 1217MF10077
04 1217MF10085
05 1217MF10086
06 1217MF10097
07 1217MF10099
08 1218MF10270
09 1218MF10740
10 1218MF10844
11 1219MF10226
12 1219MF10229
13 1219MF10230
14 1219MF10233
15 1219MF10375
16 1220MF10189
17 1222MF10051
18 1222MF10198
19 1222MF10199
20 1222MF10219
21 1222MF10231
22 1222MF10280
23 1223MF10088
24 1223MF10089
25 1223MF10164
26 1224MF10163
27 1224MF10238
28 1225MF10106
29 1225MF10202
30 1226MF10133
31 1227MF10015
32 1227MF10128
33 1227MF10130
34 1227MF10289
35 1227MF10290
36 1227MF10296
37 1228MF10108
38 1229MF10107
39 1229MF10123
40 1230MF10072
41 1301MF10027
42 1304MF10101
43 1306MF10075
44 1306MF10158
45 43Blank
01 87Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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GDUFA
DMF Review : Reviewed
Rev. Date : 2023-09-20
Pay. Date : 2023-09-15
DMF Number : 2421
Submission : 1975-03-14
Status : Active
Type : II
Certificate Number : CEP 2018-170 - Rev 03
Issue Date : 2024-10-22
Type : Chemical
Substance Number : 829
Status : Valid
Registration Number : 219MF10233
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2007-07-06
Latest Date of Registration :
NDC Package Code : 68259-1307
Start Marketing Date : 2009-06-18
End Marketing Date : 2025-12-31
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 : 4687
Submission : 1982-10-14
Status : Active
Type : II
Registration Number : 226MF10133
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2014-07-02
Latest Date of Registration :
NDC Package Code : 68259-1304
Start Marketing Date : 2009-06-18
End Marketing Date : 2025-12-31
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 : 19311
Submission : 2006-03-31
Status : Inactive
Type : II
Registration Number : 222MF10219
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2010-08-10
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 : 15300
Submission : 2001-02-22
Status : Inactive
Type : II
Registration Number : 229MF10107
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2017-06-21
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 : 13908
Submission : 1998-12-22
Status : Inactive
Type : II
Registration Number : 219MF10375
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2007-12-19
Latest Date of Registration :
Registrant Name : Jeil Pharmaceutical Co., Ltd.
Registration Date : 2003-07-22
Registration Number : 21-2-ND
Manufacturer Name : Sumitomo Chemicals Co., Ltd. Gifu Plant, Oita Works
Manufacturer Address : 3750, Aza Juhachicho, Maki, Anpachicho, Anpachigun, Gifu Prefecture, 503-0125, Japan (27-1, Shinkawa 2-chome, Chuo-ku, Tokyo 104-8260, Japan)
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 : 13888
Submission : 1998-12-07
Status : Inactive
Type : II
Registration Number : 222MF10199
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2010-07-14
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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DMF Review : N/A
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DMF Number : 5631
Submission : 1984-11-30
Status : Inactive
Type : II
Registration Number : 225MF10106
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2013-05-20
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 220MF10189
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2008-08-18
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 222MF10051
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2010-02-12
Latest Date of Registration :
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 223MF10164
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2011-11-28
Latest Date of Registration :
