01 1Acetyl-L-Carnitine Hydrochloride
02 1Azaperone
03 1Chlorthalidone
04 1Clobenzorex Hydrochloride
05 1Clomiphene Citrate
06 1Closantel Sodium
07 1Furazidin
08 1Gabapentin
09 1Ipidacrine Hydrochloride Hydrate
10 1Lamotrigine
11 1Lysine
12 1Mebhydroline Napadisylate
13 1Menadione
14 1Menadione Sodium Bisulfite
15 1Nitrofurazone
16 1Quetiapine Hemifumarate
17 1Ronidazole
18 1Sulfapyridine
19 1Tiazotic Acid
20 1Vitamin K1
21 1Vitamin K2
01 2Active
02 1Inactive
03 18Blank
01 4Suspended by EDQM GMP non-compliance
02 17Blank
01 1218MF10262
02 20Blank
01 21Blank
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34409
Submission : 2020-04-09
Status : Active
Type : II
Certificate Number : CEP 2017-285 - Rev 01
Issue Date : 2024-03-05
Type : Chemical
Substance Number : 546
Status : Suspended by EDQM G...
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2024-03-07
Pay. Date : 2024-03-04
DMF Number : 7590
Submission : 1988-07-18
Status : Active
Type : II
Certificate Number : R1-CEP 2003-193 - Rev 04
Issue Date : 2020-08-07
Type : Chemical
Substance Number : 997
Status : Suspended by EDQM G...
NDC Package Code : 17369-817
Start Marketing Date : 1982-01-01
End Marketing Date : 2024-12-31
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 : 21826
Submission : 2008-07-28
Status : Inactive
Type : II
Certificate Number : R1-CEP 2015-334 - Rev 00
Issue Date : 2022-01-04
Type : Chemical
Substance Number : 2541
Status : Suspended by EDQM G...
Registrant Name : Samoh Pharmaceutical Co., Ltd.
Registration Date : 2012-12-11
Registration Number : 20121211-172-I-113-08
Manufacturer Name : Menadiona SL
Manufacturer Address : Pol. Ind. Mas Puigvert s/n 08389 PALAFOLLS Barcelona, Spain
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registration Number : 218MF10262
Registrant's Address : Poligono Inds. Mas Puigvert Ctra. National II, Km. 680,5,08389 Palafolls, Barcelona, Spain
Initial Date of Registration : 2006-02-17
Latest Date of Registration :