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Product List of all Active Pharmaceutical Ingredients (APIs) supplied/manufactured by Synthon Pharmaceuticals

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Synthon Pharmaceuticals
Netherlands1 Flag
Country
Country
Netherlands
Address
Address
PO Box 70716503 GN NijmegenThe Netherlands
Telephone
Telephone
(+31) 24 372 77 00
Linkedin
Linkedin
Twitter
Twitter

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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2015-253 - Rev 00
Valid
Flumazenil
2022-05-24
Japanese DMF

Found JDMF

227MF10174
Flumazenil at Brnenska 32, 678 17 B...
2015-06-26
Written Confirmation

Close WC

Application Number
227MF10174
Status
Valid
 
Filing Details
Flumazenil
Flumazenil at Brnenska 32, 678 17 B...
Issue/Submission Date
2022-05-24
2015-06-26
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2016-154 - Rev 00
Valid
Gefitinib
2022-06-07
Japanese DMF

Found JDMF

229MF10200
Gefitinib at Brnenska 32/cp. 597 67...
2017-11-14
Written Confirmation

Close WC

Application Number
229MF10200
Status
Valid
 
Filing Details
Gefitinib
Gefitinib at Brnenska 32/cp. 597 67...
Issue/Submission Date
2022-06-07
2017-11-14
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USDMF

Found USDMF

33987
Active
SUGAMMADEX OCTASODIUM
2019-07-10
CEP/COS

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Japanese DMF

Found JDMF

305MF10012
Sugammadex octasodium at Brnenska 3...
2023-02-02
Written Confirmation

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Application Number
33987
305MF10012
Status
Active
Fees Paid
Reviewed
 
Filing Details
SUGAMMADEX OCTASODIUM
Sugammadex octasodium at Brnenska 3...
Issue/Submission Date
2019-07-10
2023-02-02
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2015-254 - Rev 00
Valid
Anastrozole
2022-03-21
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Anastrozole
Issue/Submission Date
2022-03-21
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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2019-191 - Rev 00
Valid
Aripiprazole
2020-09-25
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Aripiprazole
Issue/Submission Date
2020-09-25
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USDMF

Found USDMF

37971
Active
AXITINIB
2023-02-02
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
37971
Status
Active
Fees Paid
Reviewed
 
Filing Details
AXITINIB
Issue/Submission Date
2023-02-02
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2012-153 - Rev 01
Valid
Bicalutamide
2021-09-29
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Bicalutamide
Issue/Submission Date
2021-09-29
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USDMF

Found USDMF

36447
Active
ENZALUTAMIDE
2021-10-29
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
36447
Status
Active
Fees Paid
Reviewed
 
Filing Details
ENZALUTAMIDE
Issue/Submission Date
2021-10-29
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USDMF

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CEP/COS

Found CEP/COS

CEP 2021-260 - Rev 01
Valid
Everolimus, BHT 2.0%
2024-02-23
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Everolimus, BHT 2.0%
Issue/Submission Date
2024-02-23
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USDMF

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CEP/COS

Found CEP/COS

CEP 2022-424 - Rev 00
Valid
Exemestane
2023-10-06
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Exemestane
Issue/Submission Date
2023-10-06
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USDMF

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CEP/COS

Found CEP/COS

R0-CEP 2020-220 - Rev 00
Valid
Fingolimod hydrochloride
2021-04-29
Japanese DMF

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Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Fingolimod hydrochloride
Issue/Submission Date
2021-04-29
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USDMF

Found USDMF

34724
Active
LENALIDOMIDE
2020-03-27
CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
34724
Status
Active
Fees Paid
Reviewed
 
Filing Details
LENALIDOMIDE
Issue/Submission Date
2020-03-27
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-269 - Rev 01
Valid
Letrozole
2016-10-25
Japanese DMF

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Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Letrozole
Issue/Submission Date
2016-10-25
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USDMF

Found USDMF

32440
Active
MIRABEGRON
2018-02-02
CEP/COS

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Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
32440
Status
Active
Fees Paid
Reviewed
 
Filing Details
MIRABEGRON
Issue/Submission Date
2018-02-02
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USDMF

Found USDMF

38668
Active
OZANIMOD HYDROCHLORIDE
2023-11-23
CEP/COS

Close CEP/COS

Japanese DMF

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Written Confirmation

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Application Number
38668
Status
Active
Fees Paid
Reviewed
 
Filing Details
OZANIMOD HYDROCHLORIDE
Issue/Submission Date
2023-11-23
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USDMF

Found USDMF

34761
Active
PALBOCICLIB
2020-04-14
CEP/COS

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Japanese DMF

Close JDMF

Written Confirmation

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Application Number
34761
Status
Active
Fees Paid
Reviewed
 
Filing Details
PALBOCICLIB
Issue/Submission Date
2020-04-14
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USDMF

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CEP/COS

Found CEP/COS

CEP 2022-272 - Rev 01
Valid
Pemetrexed disodium 2.5-hydrate
2024-03-01
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Valid
 
Filing Details
Pemetrexed disodium 2.5-hydrate
Issue/Submission Date
2024-03-01
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USDMF

Found USDMF

30696
Active
POMALIDOMIDE
2016-08-02
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
30696
Status
Active
Fees Paid
Reviewed
 
Filing Details
POMALIDOMIDE
Issue/Submission Date
2016-08-02
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-375 - Rev 00
Valid
Pramipexole dihydrochloride monohyd...
2018-05-30
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Pramipexole dihydrochloride monohyd...
Issue/Submission Date
2018-05-30
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USDMF

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CEP/COS

Found CEP/COS

R1-CEP 2010-204 - Rev 01
Valid
Tamsulosin hydrochloride
2016-10-25
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
Status
Valid
 
Filing Details
Tamsulosin hydrochloride
Issue/Submission Date
2016-10-25
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USDMF

Found USDMF

33648
Active
VALSARTAN DISODIUM
2019-03-07
CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33648
Status
Active
Fees Paid
Reviewed
 
Filing Details
VALSARTAN DISODIUM
Issue/Submission Date
2019-03-07
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USDMF

Close USDMF

CEP/COS

Caution CEP/COS

R0-CEP 2004-126 - Rev 00
Withdrawn by Holder
Risperidone
2006-10-04
Japanese DMF

Close JDMF

Written Confirmation

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Application Number
Status
Withdrawn by Holder
 
Filing Details
Risperidone
Issue/Submission Date
2006-10-04
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USDMF

Close USDMF

CEP/COS

Caution CEP/COS

R0-CEP 2011-207 - Rev 00
Expired
Zolpidem tartrate
2013-04-10
Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
Expired
 
Filing Details
Zolpidem tartrate
Issue/Submission Date
2013-04-10
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