01 1Bazayan & Co
02 2Catalent Pharma Solutions
03 1Chemi SpA
04 1Corden Pharma Bergamo S.p.A
05 1Erregierre SpA
06 1F. Hoffmann-La Roche
07 1FDC
08 1Formil Quimica Ltd
09 2Gufic Biosciences
10 1Hengdian Group
11 1Jiangsu Nhwa Pharmaceutical
12 2Johnson & Johnson Innovative Medicine
13 1LifeFirst Pharma
14 1Olon S.p.A
15 1Om Pharmaceutical Industries
16 1Sifavitor srl
17 1Unilab Chemicals & Pharmaceuticals
18 2YUNG ZIP CHEMICAL INDUSTRIAL
01 1Brazil
02 2China
03 7India
04 5Italy
05 1Switzerland
06 2Taiwan
07 4U.S.A
01 2Active
02 9Inactive
03 11Blank
01 3Valid
02 1Withdrawn by Holder
03 18Blank
01 1219MF10165
02 1228MF10221
03 20Blank
01 1WC-0055
02 1WC-0256
03 1WC-0256a1
04 19Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 17871
Submission : 2004-12-06
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30988
Submission : 2016-08-09
Status : Active
Type : II
NDC Package Code : 52935-0017
Start Marketing Date : 2006-08-09
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 : 18248
Submission : 2005-04-01
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
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DMF Number : 19943
Submission : 2006-11-08
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 9648
Submission : 1992-04-16
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 15110
Submission : 2000-10-25
Status : Inactive
Type : II
NDC Package Code : 52935-0017
Start Marketing Date : 2006-08-09
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 : 10579
Submission : 1993-11-16
Status : Inactive
Type : II
GDUFA
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DMF Number : 7040
Submission : 1987-06-24
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 24879
Submission : 2011-04-21
Status : Inactive
Type : II
Certificate Number : CEP 2022-233 - Rev 01
Issue Date : 2024-09-06
Type : Chemical
Substance Number : 935
Status : Valid
Date of Issue : 2022-06-08
Valid Till : 2025-07-07
Written Confirmation Number : WC-0055
Address of the Firm :
GDUFA
DMF Review : N/A
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DMF Number : 10912
Submission : 1994-05-20
Status : Inactive
Type : II
Certificate Number : R2-CEP 1995-007 - Rev 03
Issue Date : 2014-11-14
Type : Chemical
Substance Number : 935
Status : Valid
Registration Number : 219MF10165
Registrant's Address : Turnhoutseweg 30 B-2340 Beerse Belgium
Initial Date of Registration : 2007-05-21
Latest Date of Registration : --
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