Synopsis
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EU WC
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VMF
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JP
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South Africa
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 41776
Submission : 2025-04-15
Status : Active
Type : II

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

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC Package Code : 70596-1002
Start Marketing Date : 2021-12-27
End Marketing Date : 2026-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT

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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]About the Company : EUROAPI focuses on reinventing active ingredient solutions to sustainably meet the needs of customers and patients worldwide. The company is a leading API player with a portfolio o...
About the Company : Transo-Pharm is a licensed distributor of pharmaceutical components for human and veterinary markets. The company supports the full API life cycle, from development to sales, and a...
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
About the Company : Omgene Life Sciences Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...
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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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

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Global Sales Information
Market Place
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15 Sep 2025
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04 Jul 2025
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25 Sep 2024
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18 Jan 2024

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