01 1Aarti Drugs
02 1Apotex Pharmachem
03 1Boehringer Ingelheim GmbH
04 1CSPC Pharmaceutical Group
05 1ChemSource
06 1Corden Pharma Bergamo S.p.A
07 3Fako Ilaçlari A.S. TR 34390 Istanbul
08 1Genpharma
09 1Grand Health Industrial Co Ltd
10 1Heumann
11 1Jiangsu Hanstone
12 1Kores India Limited
13 1Maprimed
14 1NOVOPHARM LTD
15 1Orchev Pharma
16 2Quimica Sintetica
17 2RANBAXY LABORATORIES LIMITED
18 4SMS Pharmaceuticals
19 2Saraca Laboratories Limited
20 1Shasun Chemicals and Drugs Ltd
21 1Sms Lifesciences
22 2Solara Active Pharma Sciences
23 1Sun Pharmaceutical Industries Limited
24 2UQUIFA
25 1Vera Laboratories Ltd IN 500 004 Hyderabad
26 2Wockhardt
27 3Blank
01 1Argentina
02 2Canada
03 3China
04 2Germany
05 19India
06 1Italy
07 1Morocco
08 4Spain
09 3Turkey
10 1U.S.A
11 3Blank
01 3Active
02 29Inactive
03 8Blank
01 5Expired
02 1Suspended by EDQM Failure to CEP procedure
03 3Valid
04 5Withdrawn by Holder
05 26Blank
01 1218MF10877
02 1226MF10189
03 38Blank
01 1WC-0073
02 1WC-0127
03 1WC-0181
04 1WC-0185
05 1WC-0373
06 35Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-15
Pay. Date : 2013-12-09
DMF Number : 8288
Submission : 1989-11-17
Status : Active
Type : II
Certificate Number : R1-CEP 1996-102 - Rev 04
Issue Date : 2016-06-23
Type : Chemical
Substance Number : 946
Status : Withdrawn by Holder
NDC Package Code : 49711-0107
Start Marketing Date : 2009-10-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samchundang Pharmaceutical Co., Ltd.
Registration Date : 2015-08-19
Registration Number : 20050831-35-B-92-01(12)
Manufacturer Name : UNION QUIMICOFARMACEUTICA,SA@Union quimico farmaceutica, SA
Manufacturer Address : Poligon Industrial El Pla. Av. Puigcerda No 9, C-17, km 17.4, 08185 Llica de Vall (Barcelona), Spain@Poligon Industrial El Pla. Av. Puigcerda No 9, C-17, km 17.4, 08185 Llica de Vall (Barcelona), Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 25851
Submission : 2012-02-28
Status : Active
Type : II
Certificate Number : R1-CEP 2007-320 - Rev 02
Issue Date : 2017-11-03
Type : Chemical
Substance Number : 946
Status : Suspended by EDQM F...
Date of Issue : 2019-08-13
Valid Till : 2022-08-12
Written Confirmation Number : WC-0073
Address of the Firm :
Registrant Name : Daewoong Pharmaceutical Co., Ltd.
Registration Date : 2013-10-29
Registration Number : 20101215-35-B-294-09(1)
Manufacturer Name : Orchev pharma Pvt. Ltd.
Manufacturer Address : Shapar Industrial Area, Rajkot-Gondal Highway, Veraval, Dist. Rajkot. India.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10885
Submission : 1994-04-25
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14415
Submission : 1999-10-06
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15125
Submission : 2000-10-31
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15994
Submission : 2002-06-05
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11839
Submission : 1996-01-17
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10273
Submission : 1993-05-27
Status : Inactive
Type : II
NDC Package Code : 49711-0107
Start Marketing Date : 2009-10-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Samchundang Pharmaceutical Co., Ltd.
Registration Date : 2015-08-19
Registration Number : 20050831-35-B-92-01(12)
Manufacturer Name : UNION QUIMICOFARMACEUTICA,SA@Union quimico farmaceutica, SA
Manufacturer Address : Poligon Industrial El Pla. Av. Puigcerda No 9, C-17, km 17.4, 08185 Llica de Vall (Barcelona), Spain@Poligon Industrial El Pla. Av. Puigcerda No 9, C-17, km 17.4, 08185 Llica de Vall (Barcelona), Spain
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14468
Submission : 1999-10-06
Status : Inactive
Type : II
Certificate Number : CEP 2001-228 - Rev 11
Issue Date : 2024-03-25
Type : Chemical
Substance Number : 946
Status : Valid
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
NDC Package Code : 72643-012
Start Marketing Date : 1983-06-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 15529
Submission : 2001-07-13
Status : Inactive
Type : II
NDC Package Code : 72643-012
Start Marketing Date : 1983-06-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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