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01 1Jai Radhe Sales
02 2Aarti Drugs
03 1Catalytica
04 1China Chemical & Pharmaceutical
05 2Cipla
06 1DEAFARMA
07 1Globela Pharma
08 1Ishita Drugs & Industries
09 1KYORIN PHARMACEUTICAL CO LTD
10 3Krka
11 1NAKODA CHEMICALS LIMITED
12 1Quimica Sintetica
13 1Smilax Laboratories Limited
14 2Smruthi Organics
15 1Sreepathi Pharmaceuticals
16 2Yoshindo
17 1Zhejiang Lepu Pharmaceutical
18 1Zhejiang Neo-Dankong Pharm. Co.,Ltd.
01 3China
02 13India
03 1Italy
04 3Japan
05 3Slovenia
06 1Spain
01 7Inactive
02 17Blank
01 4Valid
02 1Withdrawn by EDQM Failure to CEP procedure
03 2Withdrawn by Holder
04 17Blank
01 1218MF10336
02 1218MF10448
03 1225MF10086
04 1226MF10208
05 20Blank
01 1WC-0018
02 1WC-0068
03 1WC-0153
04 1WC-0158A2
05 1WC-0406
06 1WC-0406n1
07 18Blank
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5195
Submission : 1983-12-21
Status : Inactive
Type : II
Registration Number : 218MF10336
Registrant's Address : 2-5 Kanda Surugadai, Chiyoda-ku, Tokyo
Initial Date of Registration : 2006-03-09
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11139
Submission : 1994-10-13
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8490
Submission : 1990-03-20
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8415
Submission : 1990-02-06
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-375 - Rev 03
Issue Date : 2014-07-28
Type : Chemical
Substance Number : 1248
Status : Withdrawn by Holder
NDC Package Code : 53104-7517
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11811
Submission : 1996-01-15
Status : Inactive
Type : II
NDC Package Code : 53104-7517
Start Marketing Date : 2016-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19021
Submission : 2005-12-05
Status : Inactive
Type : II
Certificate Number : R1-CEP 2001-409 - Rev 02
Issue Date : 2010-04-01
Type : Chemical
Substance Number : 1248
Status : Withdrawn by EDQM F...
Date of Issue : 2021-05-10
Valid Till : 2024-01-24
Written Confirmation Number : WC-0158A2
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 9360
Submission : 1991-10-02
Status : Inactive
Type : II
Certificate Number : CEP 2006-037 - Rev 04
Issue Date : 2024-02-19
Type : Chemical
Substance Number : 1248
Status : Valid
Certificate Number : CEP 2021-140 - Rev 01
Issue Date : 2024-03-28
Type : Chemical
Substance Number : 1248
Status : Valid
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