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Not Confirmed
24-26 February, 2026
BIO Partnering at JPMBIO Partnering at JPM
Industry Trade Show
Not Confirmed
12-15 January, 2026
Biotech ShowcaseBiotech Showcase
Industry Trade Show
Not Confirmed
12-14 January, 2026
Digital content

27 Oct 2025
// BUSINESS WIRE
https://www.businesswire.com/news/home/20251027916986/en/Hovione-Completes-Initial-%24100M-Investment-Cycle-to-Expand-U.S.-Operations-at-New-Jersey-Manufacturing-Site

06 May 2025
// CONTRACTPHARMA
https://www.contractpharma.com/breaking-news/hovione-firstgene-partner-on-hcc-targeted-therapy/

26 Nov 2024
// FIERCE PHARMA
https://www.fiercepharma.com/manufacturing/portuguese-cdmo-hovione-completes-factory-expansions-us-ireland

03 Oct 2024
// PRESS RELEASE
https://www.hovione.com/press-room/press-release/hovione-and-zerion-pharma-create-joint-venture-further-expand-use-dispersome-technology

19 Sep 2024
// CONTRACT PHARMA
https://www.contractpharma.com//contents/view_breaking-news/2024-09-19/hovione-and-ibet-launch-new-joint-venture-visync-technologies/?widget=listSection

09 Sep 2024
// PRESS RELEASE
https://www.hovione.com/press-room/news/hovione-commits-science-based-targets-greenhouse-gas-ghg-emissions
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-15
Pay. Date : 2012-12-14
DMF Number : 16334
Submission : 2002-12-20
Status : Active
Type : II
Certificate Number : CEP 2011-103 - Rev 05
Issue Date : 2024-03-07
Type : Chemical
Substance Number : 1750
Status : Valid
Registration Number : 223MF10176
Registrant's Address : Sete Casas 2674-506 Loures PORTUGAL
Initial Date of Registration : 2011-12-27
Latest Date of Registration :
NDC Package Code : 55018-301
Start Marketing Date : 2018-11-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Synex Co., Ltd.
Registration Date : 2021-03-25
Registration Number : 20210325-209-J-917
Manufacturer Name : Hovione FarmaCiencia SA
Manufacturer Address : Sete Casas, Loures, 2674-506 Portugal

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-09
Pay. Date : 2012-12-14
DMF Number : 21395
Submission : 2008-03-05
Status : Active
Type : II
Certificate Number : R1-CEP 1998-138 - Rev 05
Issue Date : 2020-02-28
Type : Chemical
Substance Number : 1336
Status : Valid
Registration Number : 221MF10281
Registrant's Address : Estrada Coronel Nicolau de Mesquita Taipa, Macau S. A. R. China
Initial Date of Registration : 2009-12-18
Latest Date of Registration :
NDC Package Code : 55018-221
Start Marketing Date : 2009-03-19
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-15
Pay. Date : 2012-12-14
DMF Number : 13738
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R0-CEP 2022-299 - Rev 00
Issue Date : 2022-10-11
Type : Chemical
Substance Number : 1030
Status : Valid
Registration Number : 219MF10124
Registrant's Address : Sete Casas 2674-506 Loures PORTUGAL
Initial Date of Registration : 2007-04-18
Latest Date of Registration :
NDC Package Code : 50909-9201
Start Marketing Date : 2015-01-12
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 13636
Submission : 1998-09-01
Status : Inactive
Type : II
Certificate Number : CEP 1996-066 - Rev 07
Issue Date : 2024-07-18
Type : Chemical
Substance Number : 272
Status : Valid
Registration Number : 224MF10204
Registrant's Address : Estrada Coronel Nicolau de Mesquita Taipa, Macau S. A. R. China
Initial Date of Registration : 2012-10-09
Latest Date of Registration :
NDC Package Code : 50909-8105
Start Marketing Date : 2014-10-10
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-11
Pay. Date : 2012-12-11
DMF Number : 13710
Submission : 1998-09-01
Status : Active
Type : II
Certificate Number : R1-CEP 1997-115 - Rev 07
Issue Date : 2021-09-10
Type : Chemical
Substance Number : 820
Status : Valid
NDC Package Code : 50909-8106
Start Marketing Date : 2014-07-30
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 31713
Submission : 2017-05-31
Status : Active
Type : II
Certificate Number : CEP 2024-146 - Rev 00
Issue Date : 2025-07-22
Type : Chemical
Substance Number : 2768
Status : Valid
NDC Package Code : 50909-5171
Start Marketing Date : 2017-05-31
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2014-01-24
Pay. Date : 2012-12-14
DMF Number : 24791
Submission : 2011-03-25
Status : Active
Type : II
Certificate Number : CEP 2005-160 - Rev 03
Issue Date : 2025-12-02
Type : Chemical
Substance Number : 1750
Status : Valid
NDC Package Code : 50909-5175
Start Marketing Date : 2002-12-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2015-07-29
Pay. Date : 2015-04-28
DMF Number : 29003
Submission : 2015-01-08
Status : Active
Type : II
Certificate Number : CEP 1997-078 - Rev 09
Issue Date : 2024-07-17
Type : Chemical
Substance Number : 1030
Status : Valid
NDC Package Code : 50909-9101
Start Marketing Date : 1993-07-07
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2013-01-18
Pay. Date : 2012-12-14
DMF Number : 14991
Submission : 2000-05-26
Status : Active
Type : II
Certificate Number : R1-CEP 2004-111 - Rev 02
Issue Date : 2021-10-29
Type : Chemical
Substance Number : 1449
Status : Valid
NDC Package Code : 50909-5152
Start Marketing Date : 2012-04-23
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-03-07
Pay. Date : 2016-10-14
DMF Number : 25987
Submission : 2012-04-23
Status : Active
Type : II
Certificate Number : CEP 2018-121 - Rev 03
Issue Date : 2023-10-23
Type : Chemical
Substance Number : 2858
Status : Valid
NDC Package Code : 50909-5151
Start Marketing Date : 2000-05-01
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
Inspections and registrations
Country : Portugal
City/Region : Loures
Audit Date : 2026-05-12
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
Hovione is a supplier offers 69 products (APIs, Excipients or Intermediates).
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