01 1ACE Japan Co Ltd
02 1COSMA S.p.A
03 1Centaur Pharmaceuticals
04 1Derivados Quimicos SAU
05 1Dishman Carbogen Amcis
06 1Glenmark Life Sciences
07 1Guangzhou Topwork Chemical
08 2Guangzhou Tosun Pharmaceutical
09 1Hetero Drugs
10 1Lupin Ltd
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13 1Micro Labs Limited
14 1Olon S.p.A
15 2Pierre Fabre
16 1RANBAXY LABORATORIES LIMITED
17 1Raks Pharma
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01 13Active
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01 1218MF10644
02 1218MF10844
03 1218MF10857
04 1223MF10075
05 1305MF10092
06 18Blank
01 1WC-0016
02 1WC-0022
03 1WC-0041
04 1WC-0057n
05 1WC-0062
06 1WC-0135
07 1WC-0225
08 16Blank
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GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-31
Pay. Date : 2012-11-07
DMF Number : 26611
Submission : 2012-11-07
Status : Active
Type : II
NDC Package Code : 59349-0021
Start Marketing Date : 2018-11-07
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 : 26642
Submission : 2012-11-26
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-04-26
Pay. Date : 2012-12-11
DMF Number : 26399
Submission : 2012-09-06
Status : Active
Type : II
Date of Issue : 2019-06-26
Valid Till : 2022-06-25
Written Confirmation Number : WC-0016
Address of the Firm :
NDC Package Code : 65015-814
Start Marketing Date : 2015-02-18
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-11-21
Pay. Date : 2013-08-23
DMF Number : 25022
Submission : 2011-06-27
Status : Active
Type : II
Registration Number : 223MF10075
Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Maharashtra, India
Initial Date of Registration : 2011-05-31
Latest Date of Registration : --
Date of Issue : 2022-06-07
Valid Till : 2025-06-25
Written Confirmation Number : WC-0057n
Address of the Firm :
NDC Package Code : 66039-875
Start Marketing Date : 2011-08-12
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-07-25
Pay. Date : 2012-12-05
DMF Number : 26624
Submission : 2012-11-19
Status : Active
Type : II
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-01
Pay. Date : 2017-01-24
DMF Number : 30983
Submission : 2016-12-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 11501
Submission : 1995-05-11
Status : Active
Type : II
Registration Number : 218MF10644
Registrant's Address : 16 rue Jean Rostand ZI de Clergous 81600 GAILLAC FRANCE
Initial Date of Registration : 2006-07-20
Latest Date of Registration : --
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31412
Submission : 2017-02-15
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-21
Written Confirmation Number : WC-0062
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 22741
Submission : 2009-04-23
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24073
Submission : 2010-06-30
Status : Inactive
Type : II
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