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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Jiangxi Synergy Pharmaceutical

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01 Aceclofenac (1)

02 Apixaban (1)

03 Azilsartan (2)

04 Canagliflozin (1)

05 Candesartan Cilexetil (2)

06 Celecoxib (1)

07 Dabigatran Etexilate Mesylate (1)

08 Edoxaban Tosylate (1)

09 Empagliflozin (1)

10 Febuxostat (1)

11 Gabapentin (3)

12 Mirabegron (1)

13 Rebamipide (3)

14 Rivaroxaban (1)

15 Telmisartan (1)

16 Ticagrelor (1)

17 Vildagliptin (1)

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01 Active (13)

02 Inactive (5)

03 Blank (5)

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01 Valid (7)

02 Withdrawn by Holder (1)

03 Blank (15)

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01 221MF10056 (1)

02 222MF10239 (1)

03 224MF10057 (1)

04 228MF10089 (1)

05 230MF10124 (1)

06 230MF10146 (1)

07 302MF10016 (1)

08 304MF10027 (1)

09 305MF10024 (1)

10 305MF10141 (1)

11 Blank (13)

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01 Blank (23)

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USDMF

Found USDMF

25582
Active
CELECOXIB
2011-08-16
CEP/COS

Found CEP/COS

R1-CEP 2012-404 - Rev 00
Valid
Celecoxib
2019-07-04
Japanese DMF

Found JDMF

230MF10124
Celecoxib at Jiangxi Fengxin Indust...
2018-09-03
Written Confirmation

Close WC

Application Number
25582
230MF10124
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CELECOXIB
Celecoxib
Celecoxib at Jiangxi Fengxin Indust...
Issue/Submission Date
2011-08-16
2019-07-04
2018-09-03
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USDMF

Found USDMF

31601
Active
RIVAROXABAN
2017-03-16
CEP/COS

Found CEP/COS

CEP 2021-047 - Rev 01
Valid
Rivaroxaban
2023-09-28
Japanese DMF

Found JDMF

304MF10027
Rivaroxaban at Jiangxi Fengxin Indu...
2022-02-10
Written Confirmation

Close WC

Application Number
31601
304MF10027
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
RIVAROXABAN
Rivaroxaban
Rivaroxaban at Jiangxi Fengxin Indu...
Issue/Submission Date
2017-03-16
2023-09-28
2022-02-10
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USDMF

Caution USDMF

23649
Inactive
CANDESARTAN CILEXETIL
2010-03-18
CEP/COS

Found CEP/COS

CEP 2013-007 - Rev 03
Valid
Candesartan cilexetil
2023-09-20
Japanese DMF

Found JDMF

230MF10146
Candesartan Cilexetil at Jiangxi Fe...
2018-11-05
Written Confirmation

Close WC

Application Number
23649
230MF10146
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
CANDESARTAN CILEXETIL
Candesartan cilexetil
Candesartan Cilexetil at Jiangxi Fe...
Issue/Submission Date
2010-03-18
2023-09-20
2018-11-05
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USDMF

Found USDMF

25825
Active
GABAPENTIN
2012-02-22
CEP/COS

Found CEP/COS

R0-CEP 2019-343 - Rev 01
Valid
Gabapentin, Process II
2023-02-16
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
25825
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
GABAPENTIN
Gabapentin, Process II
Issue/Submission Date
2012-02-22
2023-02-16
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USDMF

Found USDMF

31620
Active
TICAGRELOR
2017-03-24
CEP/COS

Found CEP/COS

R0-CEP 2021-303 - Rev 00
Valid
Ticagrelor
2023-08-08
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
31620
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
TICAGRELOR
Ticagrelor
Issue/Submission Date
2017-03-24
2023-08-08
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USDMF

Found USDMF

31663
Active
VILDAGLIPTIN
2017-04-05
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

305MF10024
Vildagliptin at Jiangxi Fengxin Ind...
2023-02-08
Written Confirmation

Close WC

Application Number
31663
305MF10024
Status
Active
Fees Paid
N/A
 
Filing Details
VILDAGLIPTIN
Vildagliptin at Jiangxi Fengxin Ind...
Issue/Submission Date
2017-04-05
2023-02-08
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USDMF

Caution USDMF

24210
Inactive
ACECLOFENAC
2010-09-24
CEP/COS

Found CEP/COS

R1-CEP 2013-274 - Rev 01
Valid
Aceclofenac
2021-07-20
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24210
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
ACECLOFENAC
Aceclofenac
Issue/Submission Date
2010-09-24
2021-07-20
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USDMF

Caution USDMF

21401
Inactive
GABAPENTIN
2008-02-29
CEP/COS

Found CEP/COS

R1-CEP 2011-264 - Rev 00
Valid
Gabapentin
2017-10-25
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
21401
Status
Inactive
Fees Paid
N/A
Valid
 
Filing Details
GABAPENTIN
Gabapentin
Issue/Submission Date
2008-02-29
2017-10-25
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USDMF

Caution USDMF

21700
Inactive
REBAMIPIDE
2008-06-09
CEP/COS

Close CEP/COS

Japanese DMF

Found JDMF

228MF10089
Rebamipide at Jiangxi Fengxin Indu...
2016-04-15
Written Confirmation

Close WC

Application Number
21700
228MF10089
Status
Inactive
Fees Paid
N/A
 
Filing Details
REBAMIPIDE
Rebamipide at Jiangxi Fengxin Indu...
Issue/Submission Date
2008-06-09
2016-04-15
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USDMF

Found USDMF

32781
Active
APIXABAN
2018-04-21
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

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Application Number
32781
Status
Active
Fees Paid
Reviewed
 
Filing Details
APIXABAN
Issue/Submission Date
2018-04-21
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