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Digital content

04 Sep 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/zydus-and-synthon-entered-into-exclusive-licensing-and-supply-agreement-for-ozanimod-capsules-generic-version-of-zeposia-for-the-us-market-302546536.html

22 Jul 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219236

13 Feb 2025
// EXPRESS PHARMA
https://www.expresspharma.in/zydus-lifesciences-signs-agreement-with-synthon-bv-for-505b2-oncology-product/

25 Sep 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206873

25 Sep 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=203857

05 Jun 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215570
GDUFA
DMF Review : Complete
Rev. Date : 2023-06-27
Pay. Date : 2023-02-06
DMF Number : 37971
Submission : 2023-02-02
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2021-12-07
Pay. Date : 2021-10-27
DMF Number : 36447
Submission : 2021-10-29
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-03-04
Pay. Date : 2025-01-24
DMF Number : 41022
Submission : 2025-01-30
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2020-04-17
Pay. Date : 2020-03-24
DMF Number : 34724
Submission : 2020-03-27
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2018-03-01
Pay. Date : 2018-02-01
DMF Number : 32440
Submission : 2018-02-02
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2024-01-22
Pay. Date : 2023-11-17
DMF Number : 38668
Submission : 2023-11-23
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2020-05-08
Pay. Date : 2020-04-06
DMF Number : 34761
Submission : 2020-04-14
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2016-11-30
Pay. Date : 2016-08-04
DMF Number : 30696
Submission : 2016-08-02
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2025-10-22
Pay. Date : 2025-09-23
DMF Number : 41019
Submission : 2025-09-25
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2019-10-31
Pay. Date : 2019-07-08
DMF Number : 33987
Submission : 2019-07-10
Status : Active
Type : II

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CEP/COS
Certificate Numbers : R1-CEP 2015-254 - Rev 00
Status : Valid
Issue Date : 2022-03-21
Type : Chemical
Substance Number : 2406

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CEP/COS
Certificate Numbers : CEP 2019-191 - Rev 02
Status : Valid
Issue Date : 2025-09-11
Type : Chemical
Substance Number : 2617

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CEP/COS
Certificate Numbers : CEP 2012-153 - Rev 03
Status : Valid
Issue Date : 2024-09-18
Type : Chemical
Substance Number : 2196

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CEP/COS
Certificate Numbers : CEP 2021-260 - Rev 01
Status : Valid
Issue Date : 2024-02-23
Type : Chemical
Substance Number : 2918

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CEP/COS
Certificate Numbers : CEP 2022-424 - Rev 02
Status : Valid
Issue Date : 2025-10-17
Type : Chemical
Substance Number : 2766

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CEP/COS
Certificate Numbers : R0-CEP 2020-220 - Rev 00
Status : Valid
Issue Date : 2021-04-29
Type : Chemical
Substance Number : 2988

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CEP/COS
Certificate Numbers : CEP 2015-253 - Rev 01
Status : Valid
Issue Date : 2024-09-25
Type : Chemical
Substance Number : 1326

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CEP/COS
Certificate Numbers : CEP 2016-154 - Rev 01
Status : Valid
Issue Date : 2025-12-10
Type : Chemical
Substance Number : 2866

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CEP/COS
Certificate Numbers : CEP 2010-269 - Rev 02
Status : Valid
Issue Date : 2024-11-27
Type : Chemical
Substance Number : 2334

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CEP/COS
Certificate Numbers : CEP 2022-272 - Rev 01
Status : Valid
Issue Date : 2024-03-01
Type : Chemical
Substance Number : 3046

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Registration Number : 307MF10030
Registrant's Address : Brnenska 32/cp. 597 678 01 Blansko Czech Republic
Initial Date of Registration : 2025-02-07
Latest Date of Registration : 2025-11-13

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JDMF
Registration Number : 227MF10174
Registrant's Address : Brnenska 32/cp. 597 678 01 Blansko Czech Republic
Initial Date of Registration : 2015-06-26
Latest Date of Registration : 2015-06-26

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JDMF
Registration Number : 229MF10200
Registrant's Address : Brnenska 32/cp. 597 678 01 Blansko Czech Republic
Initial Date of Registration : 2017-11-14
Latest Date of Registration : 2021-10-21

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Registration Number : 305MF10012
Registrant's Address : Brnenska 32/cp. 597 678 01 Blansko Czech Republic
Initial Date of Registration : 2023-02-02
Latest Date of Registration : 2023-02-02

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Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2017-11-10
Registration Number : Su522-4-ND
Manufacturer Name : Synthon sro
Manufacturer Address : Brneska 32/cp.597, 678 01 Blansko, Czech Republic

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Registrant Name : Kwangdong Pharmaceutical Co., Ltd.
Registration Date : 2021-11-08
Registration Number : 20211108-209-J-1142
Manufacturer Name : Synthon, sro
Manufacturer Address : Brneska 32/cp.597, 678 01 Blansko, Czech Republic

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Registrant Name : Alvogen Korea Co., Ltd.
Registration Date : 2014-10-20
Registration Number : Su3834-3-ND
Manufacturer Name : Synthon, sro
Manufacturer Address : Brneska 32/cp.597, 678 01 Blansko, Czech Republic_x000D_

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Registrant Name : Masung LS Co., Ltd.
Registration Date : 2024-04-30
Registration Number : Su163-35-ND
Manufacturer Name : Synthon, sro
Manufacturer Address : Brnenska 32/cp.597, 678 01 Blansko, Czech Republic

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Registrant Name : Masung LS Co., Ltd.
Registration Date : 2019-10-14
Registration Number : 20191014-73-A-354-04
Manufacturer Name : Synthon, sro
Manufacturer Address : Brneska 32/cp.597, 678 01 Blansko, Czech Republic

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Registrant Name : Kwangdong Pharmaceutical Co., Ltd.
Registration Date : 2022-12-05
Registration Number : Su0150-2-ND
Manufacturer Name : Synthon, sro
Manufacturer Address : Brněnská 32/čp.597, Blansko 678 01, Czech Republic

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Registrant Name : Kukjeon Pharmaceutical Co., Ltd.
Registration Date : 2020-12-03
Registration Number : Su173-30-ND
Manufacturer Name : Synthon, sro
Manufacturer Address : Brneska 32/cp.597, 678 01 Blansko, Czech Republic

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Registrant Name : GlaxoSmithKline Inc.
Registration Date : 2020-09-08
Registration Number : 20200908-209-J-468
Manufacturer Name : Synthon, sro
Manufacturer Address : Brenenska 32/cp. 597, 678 01 Blansko, Czech Republic

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Registrant Name : Masung LS Co., Ltd.
Registration Date : 2024-04-09
Registration Number : 20200908-209-J-468(A)
Manufacturer Name : Synthon, sro
Manufacturer Address : Brenenska 32/cp. 597, 678 01 Blansko, Czech Republic

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Inspections and registrations
Country : Spain
City/Region : Sant Bot De Llobregat
Audit Date : 2025-09-16
Audit Type : On-Site
Country : Czech Republic
City/Region : Blansko
Audit Date : 2024-11-06
Audit Type : On-Site
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Synthon Pharmaceuticals, Inc is a supplier offers 31 products (APIs, Excipients or Intermediates).
Find a price of Flumazenil bulk with CEP, JDMF offered by Synthon Pharmaceuticals, Inc
Find a price of Gefitinib bulk with CEP, JDMF offered by Synthon Pharmaceuticals, Inc
Find a price of Sugammadex Sodium bulk with DMF, JDMF offered by Synthon Pharmaceuticals, Inc
Find a price of Anagrelide Hydrochloride bulk with JDMF offered by Synthon Pharmaceuticals, Inc
Find a price of Anastrozole bulk with CEP offered by Synthon Pharmaceuticals, Inc
Find a price of Aripiprazole bulk with CEP offered by Synthon Pharmaceuticals, Inc
Find a price of Axitinib bulk with DMF offered by Synthon Pharmaceuticals, Inc
Find a price of Bicalutamide bulk with CEP offered by Synthon Pharmaceuticals, Inc
Find a price of Enzalutamide bulk with DMF offered by Synthon Pharmaceuticals, Inc
Find a price of Everolimus bulk with CEP offered by Synthon Pharmaceuticals, Inc
Find a price of Exemestane bulk with CEP offered by Synthon Pharmaceuticals, Inc
Find a price of Fingolimod Hydrochloride bulk with CEP offered by Synthon Pharmaceuticals, Inc
Find a price of Ixazomib Citrate bulk with DMF offered by Synthon Pharmaceuticals, Inc
Find a price of Lenalidomide bulk with DMF offered by Synthon Pharmaceuticals, Inc
Find a price of Letrozole bulk with CEP offered by Synthon Pharmaceuticals, Inc
Find a price of Mirabegron bulk with DMF offered by Synthon Pharmaceuticals, Inc
Find a price of Ozanimod bulk with DMF offered by Synthon Pharmaceuticals, Inc
Find a price of Palbociclib bulk with DMF offered by Synthon Pharmaceuticals, Inc
Find a price of Pemetrexed Disodium bulk with CEP offered by Synthon Pharmaceuticals, Inc
Find a price of Pomalidomide bulk with DMF offered by Synthon Pharmaceuticals, Inc
Find a price of Pramipexole Dihydrochloride bulk with CEP offered by Synthon Pharmaceuticals, Inc
Find a price of Siponimod bulk with DMF offered by Synthon Pharmaceuticals, Inc
Find a price of Tamsulosin bulk with CEP offered by Synthon Pharmaceuticals, Inc
Find a price of Tivozanib bulk with DMF offered by Synthon Pharmaceuticals, Inc
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Find a price of Vismodegib bulk with DMF offered by Synthon Pharmaceuticals, Inc
Find a price of Risperidone bulk offered by Synthon Pharmaceuticals, Inc
Find a price of Zolpidem Tartrate bulk offered by Synthon Pharmaceuticals, Inc
Find a price of Bortezomib bulk offered by Synthon Pharmaceuticals, Inc
Find a price of Glatiramer Acetate bulk offered by Synthon Pharmaceuticals, Inc
Find a price of Tamsulosin bulk offered by Synthon Pharmaceuticals, Inc