Synopsis
Synopsis
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CEP/COS
0
JDMF
0
EU WC
0
VMF
0
EDQM
0
USP
0
JP
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South Africa
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Listed Dossiers
DRUG PRODUCT COMPOSITIONS
US Medicaid
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41776
Submission : 2025-04-15
Status : Active
Type : II

GDUFA
DMF Review : Reviewed
Rev. Date : 2025-10-23
Pay. Date : 2025-09-25
DMF Number : 42095
Submission : 2025-09-24
Status : Active
Type : II


USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
Registrant Name : Novartis Korea Co., Ltd.
Registration Date : 2026-02-25
Registration Number : Su196-34-ND
Manufacturer Name : Novartis Pharma Schweizerhalle AG
Manufacturer Address : Rothausstrasse, 4133, Pratteln, Switzerland


Registrant Name : Novartis Korea Co., Ltd.
Registration Date : 2024-06-20
Registration Number : Su196-29-ND
Manufacturer Name : ST Pharm Co., Ltd.
Manufacturer Address : 171 Haean-ro, Danwon-gu, Ansan-si, Gyeonggi-do

NDC Package Code : 42931-712
Start Marketing Date : 2024-11-26
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT

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| Importing Country | Total Quantity (KGS) |
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Number of Transactions |
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Regulatory Info : Prescription
Registration Country : Estonia
Brand Name : Leqvio
Dosage Form : Solution For Injection
Dosage Strength : 284mg/1.5ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Prescription
Registration Country : Estonia

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Regulatory Info : Prescription
Registration Country : Denmark
Brand Name : Leqvio
Dosage Form : Solution For Injection
Dosage Strength : 284mg
Packaging :
Approval Date : 09-12-2020
Application Number : 28106393820
Regulatory Info : Prescription
Registration Country : Denmark

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