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23-25 February, 2026
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24-25 February, 2026
Digital content

15 Jan 2026
// BUSINESSWIRE
https://www.businesswire.com/news/home/20260115316188/en/Agno-Pharma-Acquires-Actyliss-CDMO-Manufacturing-Asset-the-Legacy-Cascade-Chemistry-Business-based-in-Eugene-Oregon-Strengthening-Agnos-US-cGMP-API-Development-and-Manufacturing-Capabilities

18 Dec 2023
// BUSINESSWIRE
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34861
Submission : 2020-08-19
Status : Active
Type : II
NDC Package Code : 57821-006
Start Marketing Date : 2020-04-03
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 : 2017-07-19
Pay. Date : 2017-04-13
DMF Number : 30184
Submission : 2017-03-24
Status : Active
Type : II
NDC Package Code : 57821-002
Start Marketing Date : 2018-06-06
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Saigen Korea Co., Ltd.
Registration Date : 2025-08-22
Registration Number : 20250822-210-J-2000
Manufacturer Name : Agno Pharma Jiangsu
Manufacturer Address : 68 Dapu Road, Dapu Industrial Zone, Lianyungang Economic & Technology Development Zone, Lianyungang, Jiangsu, China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37638
Submission : 2024-10-10
Status : Active
Type : II
NDC Package Code : 57821-012
Start Marketing Date : 2022-08-26
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 : 34975
Submission : 2020-07-15
Status : Active
Type : II
NDC Package Code : 57821-003
Start Marketing Date : 2020-04-03
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 : 33360
Submission : 2018-12-01
Status : Active
Type : II
NDC Package Code : 57821-009
Start Marketing Date : 2020-11-01
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 : 33359
Submission : 2018-12-10
Status : Active
Type : II
NDC Package Code : 57821-008
Start Marketing Date : 2020-11-01
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 : 2024-11-08
Pay. Date : 2024-10-31
DMF Number : 37637
Submission : 2024-06-17
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-01-30
Pay. Date : 2016-12-28
DMF Number : 30900
Submission : 2016-12-09
Status : Active
Type : II

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 40114
Submission : 2024-08-28
Status : Active
Type : II
NDC Package Code : 57821-014
Start Marketing Date : 2023-12-01
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 : 39976
Submission : 2024-06-28
Status : Active
Type : II

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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33360
Submission : 2018-12-01
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34861
Submission : 2020-08-19
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2017-07-19
Pay. Date : 2017-04-13
DMF Number : 30184
Submission : 2017-03-24
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37638
Submission : 2024-10-10
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34975
Submission : 2020-07-15
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41195
Submission : 2025-01-15
Status : Inactive
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33359
Submission : 2018-12-10
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2024-11-08
Pay. Date : 2024-10-31
DMF Number : 37637
Submission : 2024-06-17
Status : Active
Type : II

GDUFA
DMF Review : Complete
Rev. Date : 2017-01-30
Pay. Date : 2016-12-28
DMF Number : 30900
Submission : 2016-12-09
Status : Active
Type : II

GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 20104
Submission : 2006-12-28
Status : Inactive
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
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CAS Number : 143900-44-1
End Use API : Ibrutinib
About the Company : Agno Pharma is a global pharmaceutical contract research and manufacturing organization (CRO & CMO), with a US-FDA appro...

Intermediate Web Link
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Excipients
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38746
Submission : 2024-06-26
Status : Active
Type : IV

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
NDC Package Code : 57821-013
Start Marketing Date : 2022-12-01
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]
District Decision : Voluntary Action Indicated
Inspection End Date : 2024-06-07
City : Lianyungang
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2024-06-07

District Decision : Voluntary Action Indicated
Inspection End Date : 2014-11-07
City : Lianyungang
State :
Country/Area : China
Zip :
District :
Center :
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-11-07

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
Agno Pharma is a supplier offers 18 products (APIs, Excipients or Intermediates).
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