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23-26 March, 2026
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23-24 March, 2026
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23-24 March, 2026
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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 24795-0063
Start Marketing Date : 2014-08-08
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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Details:
Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product (generic version of Zeposia), and thereafter, for the manufacture and supply of the product.
Lead Product(s): Ozanimod
Therapeutic Area: Neurology Brand Name: Zeposia
Study Phase: Approved FDFProduct Type: Miscellaneous
Sponsor: Zydus Lifesciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement September 04, 2025

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Lead Product(s) : Ozanimod
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Zydus Lifesciences
Deal Size : Undisclosed
Deal Type : Licensing Agreement
Zydus and Synthon Entered into Exclusive Licensing and Supply Agreement for Ozanimod
Details : Synthon will be responsible for obtaining final regulatory approval for its Ozanimod Capsules product (generic version of Zeposia), and thereafter, for the manufacture and supply of the product.
Product Name : Zeposia
Product Type : Miscellaneous
Upfront Cash : Undisclosed
September 04, 2025

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Details:
Zydus to handle NDA submission and commercialisation in the US and Synthon to lead development and manufacturing for oncology product.
Lead Product(s): Undisclosed
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Undisclosed
Recipient: Zydus Lifesciences
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement February 12, 2025

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Lead Product(s) : Undisclosed
Therapeutic Area : Oncology
Highest Development Status : Undisclosed
Recipient : Zydus Lifesciences
Deal Size : Undisclosed
Deal Type : Agreement
Zydus Lifesciences in Pact with Synthon for Specialty Oncology Product in US
Details : Zydus to handle NDA submission and commercialisation in the US and Synthon to lead development and manufacturing for oncology product.
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Undisclosed
February 12, 2025

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Details:
Glatiramer Acetate is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Multiple Sclerosis.
Lead Product(s): Glatiramer Acetate
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 09, 2011

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Lead Product(s) : Glatiramer Acetate
Therapeutic Area : Neurology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy and Safety of GTR in Comparison to Copaxone®
Details : Glatiramer Acetate is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Multiple Sclerosis.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 09, 2011

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]REF. STANDARDS & IMPURITIES
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
Synthon Pharmaceuticals is a supplier offers 31 products (APIs, Excipients or Intermediates).
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