01 1Arch Pharmalabs
02 1Arene Lifesciences
03 1Aspire Lifesciences Pvt Ltd
04 4Aurobindo Pharma Limited
05 1Chengda Pharmaceuticals
06 2Cipla
07 1Guangzhou Topwork Chemical
08 4Hetero Drugs
09 1Jiangsu Zhongbang Pharmaceutical Co, Ltd
10 1Laurus Labs
11 1MATRIX LABORATORIES XIAMEN LTD.
12 1Matrix Pharmaceutical Inc
13 1RANBAXY LABORATORIES LIMITED
14 1SEQUENT SCIENTIFIC LTD
15 1Shanghai Desano Bio-Pharmaceutical
16 1Shanghai Desano Chemical Pharmaceutical Co., Ltd.
17 1Sun Pharmaceutical Industries Limited
18 1Tyche Industries Ltd
19 3Viatris
20 2Zhejiang Huahai Pharmaceutical
21 1Blank
01 8China
02 18India
03 4U.S.A
04 1Blank
01 11Active
02 8Inactive
03 12Blank
01 7Valid
02 4Withdrawn by Holder
03 20Blank
01 1227MF10149
02 30Blank
01 1WC-0011
02 1WC-0023
03 1WC-0041
04 1WC-0041A4
05 1WC-0065
06 1WC-0065a
07 1WC-0118
08 1WC-0120
09 1WC-0140
10 1WC-0189
11 1WC-0213
12 20Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-27
Pay. Date : 2013-02-06
DMF Number : 24610
Submission : 2011-02-03
Status : Active
Type : II
Certificate Number : R1-CEP 2008-145 - Rev 02
Issue Date : 2018-02-08
Type : Chemical
Substance Number : 2255
Status : Withdrawn by Holder
Date of Issue : 2019-08-16
Valid Till : 2022-08-15
Written Confirmation Number : WC-0065
Address of the Firm :
NDC Package Code : 68554-0014
Start Marketing Date : 1996-06-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-02-15
Pay. Date : 2013-01-24
DMF Number : 21280
Submission : 2008-01-22
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-05-21
Pay. Date : 2013-05-10
DMF Number : 17915
Submission : 2004-12-16
Status : Active
Type : II
Date of Issue : 2019-08-05
Valid Till : 2022-08-04
Written Confirmation Number : WC-0118
Address of the Firm :
NDC Package Code : 65015-704
Start Marketing Date : 2015-01-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 17782
Submission : 2004-10-26
Status : Active
Type : II
Certificate Number : CEP 2016-076 - Rev 01
Issue Date : 2024-07-18
Type : Chemical
Substance Number : 2255
Status : Valid
Date of Issue : 2022-09-16
Valid Till : 2025-08-08
Written Confirmation Number : WC-0041
Address of the Firm :
NDC Package Code : 68554-0014
Start Marketing Date : 1996-06-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
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DMF Number : 23124
Submission : 2009-09-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 28105
Submission : 2014-03-20
Status : Inactive
Type : II
GDUFA
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DMF Number : 19368
Submission : 2006-04-14
Status : Inactive
Type : II
Date of Issue : 2019-07-26
Valid Till : 2022-07-26
Written Confirmation Number : WC-0189
Address of the Firm :
NDC Package Code : 65015-704
Start Marketing Date : 2015-01-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 23368
Submission : 2009-12-14
Status : Inactive
Type : II
NDC Package Code : 65015-704
Start Marketing Date : 2015-01-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 25221
Submission : 2011-08-22
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 19379
Submission : 2005-10-10
Status : Inactive
Type : II
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