01 1CHEMO
02 1CHEMO IBERICA SA
03 1Magle Chemoswed
04 1Sai Life Sciences Limited
05 1Solara Active Pharma Sciences
06 1Sun Pharmaceutical Industries Limited
07 1Suzhou Ryway Biotech
08 1Yangzhou Pharmaceutical
01 2China
02 3India
03 2Spain
04 1Sweden
01 4Active
02 2Inactive
03 2Blank
01 1Valid
02 7Blank
01 8Blank
01 1WC-0127
02 7Blank
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 16369
Submission : 2003-01-21
Status : Active
Type : II
Date of Issue : 2022-09-30
Valid Till : 2025-08-04
Written Confirmation Number : WC-0127
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-10-10
Pay. Date : 2014-03-20
DMF Number : 17367
Submission : 2004-05-05
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 17384
Submission : 2004-05-17
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 19376
Submission : 2006-04-19
Status : Active
Type : II
Certificate Number : R1-CEP 2007-303 - Rev 03
Issue Date : 2023-02-17
Type : Chemical
Substance Number : 2110
Status : Valid
GDUFA
DMF Review : N/A
Rev. Date :
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DMF Number : 17873
Submission : 2004-12-07
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 21013
Submission : 2007-10-29
Status : Inactive
Type : II
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