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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

NDC Package Code : 70596-1002
Start Marketing Date : 2021-12-27
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT



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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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41776
Submission : 2025-04-15
Status : Active
Type : II

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : EUROAPI is focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
About the Company : Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically...
About the Company : Anhui Ribobay Pharmaceutical Co., Ltd., known as Ribobay, was established in August 2021 as a fully owned subsidiary of General Biol. Situated in the Quanjiao industry Zone in Chuz...

About the Company : For more than 60 years, GYMA Laboratories has been the leading and trusted API supplier to the US pharmaceutical industry. We’re proud that many of the pharmaceutical manufacture...

About the Company : Sinopep leads the industry in therapeutic peptides, supplying top-demand APIs like Albuvirtide, Lanreotide, Semaglutide, and more. Renowned for high-quality peptide APIs and effici...

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31 Jul 2025
// PR NEWSWIRE
https://www.prnewswire.com/news-releases/novartis-twice-yearly-leqvio-inclisiran-receives-fda-approval-for-new-indication-enabling-first-line-use-302519118.html

27 May 2025
// ECONOMICTIMES
https://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/novartis-offers-payment-plan-for-high-cost-heart-medicine/articleshow/121421067.cms

28 Aug 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/08/28/2936719/0/en/Novartis-twice-yearly-Leqvio-demonstrated-clinically-meaningful-statistically-significant-LDL-C-lowering-as-a-monotherapy-in-patients-at-low-or-moderate-ASCVD-risk.html

09 Jul 2024
// BUSINESSWIRE

08 May 2024
// Andrea Park FIERCE PHARMA
https://www.fiercepharma.com/marketing/entresto-puts-novartis-top-docs-ranking-heart-disease-drugmakers-pfizer-close-behind

06 Apr 2024
// GLOBENEWSWIRE
https://www.globenewswire.com/news-release/2024/04/06/2858812/0/en/New-Novartis-data-show-early-addition-of-twice-yearly-Leqvio-inclisiran-following-maximally-tolerated-statin-therapy-significantly-reduces-LDL-C-in-ASCVD-patients-in-real-world-set.html
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