01 2ACS DOBFAR SPA
02 1Ajanta Pharma Limited
03 1Aurobindo Pharma Limited
04 1Bristol Myers Squibb
05 1China Union Chempharma (Suzhou) Co.,Ltd
06 1CordenPharma
07 1Grand Health Industrial Co Ltd
08 1Hikma Pharmaceuticals
09 1Lupin Ltd
10 1Orchid Pharma
11 1Qilu Pharmaceutical
12 2RANBAXY LABORATORIES LIMITED
13 1Sneha Medicare Pvt Ltd
14 1Teva API
15 3Blank
01 3China
02 1Germany
03 7India
04 1Israel
05 2Italy
06 1U.S.A
07 1United Kingdom
08 3Blank
01 5Active
02 10Inactive
03 4Blank
01 3Valid
02 1Withdrawn by Holder
03 15Blank
01 19Blank
01 1WC-0048
02 1WC-0120
03 1WC-0131
04 16Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19290
Submission : 2006-03-21
Status : Active
Type : II
Date of Issue : 2019-08-01
Valid Till : 2022-07-31
Written Confirmation Number : WC-0048
Address of the Firm : 124, GIDC Estate, Ankleshwar-393 002, Gujarat
Registrant Name : Korea Chorus Co., Ltd.
Registration Date : 2015-07-31
Registration Number : 20120106-19-A-256-09(2)
Manufacturer Name : Lupine Limited
Manufacturer Address : 124, GIDC Estate, Ankleshwar, 393 002, Gujarat, India
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17106
Submission : 2004-01-14
Status : Active
Type : II
Certificate Number : R1-CEP 2002-234 - Rev 02
Issue Date : 2016-06-30
Type : Chemical
Substance Number : 813
Status : Valid
Date of Issue : 2019-07-22
Valid Till : 2022-07-21
Written Confirmation Number : WC-0131
Address of the Firm : Plot Nos. 138-147, SIDCO Industrial Estate, Alathur, Kancheepuram District-603 110, Tamilnadu
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17509
Submission : 2004-07-01
Status : Active
Type : II
Certificate Number : R1-CEP 2005-091 - Rev 00
Issue Date : 2011-09-08
Type : Chemical
Substance Number : 813
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13225
Submission : 1998-04-30
Status : Active
Type : II
NDC Package Code : 52946-0903
Start Marketing Date : 2009-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Korea United Pharmaceutical Co., Ltd.
Registration Date : 2012-03-16
Registration Number : 20050831-19-A-11-02(6)
Manufacturer Name : ACS DOBFAR SpA
Manufacturer Address : Via Marzabotto, 7/9 20871 Vimercate (MB)-Italy
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 14201
Submission : 1999-06-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13220
Submission : 1998-04-30
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13638
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 12894
Submission : 1998-03-11
Status : Inactive
Type : II
Certificate Number : R1-CEP 1998-019 - Rev 00
Issue Date : 2003-12-18
Type : Chemical
Substance Number : 813
Status : Withdrawn by Holder
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13761
Submission : 1998-09-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13566
Submission : 1998-09-01
Status : Inactive
Type : II
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