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ACTIVE PHARMA INGREDIENTS

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USDMF

US DMFs Filed

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CEP/COS

CEP/COS Certifications

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JDMF

JDMFs Filed

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EU WC

EU WC

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KDMF

KDMF

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VMF

NDC API

API REF. PRICE (USD/KG)

MARKET PLACE

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FDF

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

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Canada

Canada

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South Africa

South Africa

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Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

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EDQM

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USP

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JP

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Others

PATENTS & EXCLUSIVITIES

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Health Canada Patents

DIGITAL CONTENT

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Stock Recap #PipelineProspector

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Weekly News Recap #Phispers

GLOBAL SALES INFORMATION

US Medicaid

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0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

Chemistry

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API SUPPLIERS

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EUROAPI

France

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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02

Transo-Pharm USA LLC

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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03

Anhui Ribobay Pharmaceutical Co.,L...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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  • fda
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Virtual BoothRibobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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04

Omgene Life Sciences Pvt. Ltd

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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05

Jiangsu Sinopep Allsino Biopharmac...

China

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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06

Gyma Laboratories of America

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Gyma Laboratories of America

U.S.A

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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NDC API

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INCLISIRAN

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

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Listed Suppliers

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01

EUROAPI

France
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  • EDQM
  • WHO-GMP

Virtual BoothEUROAPI, the leading small molecules API player, provides both API sales & CDMO services.

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Inclisiran

About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...

EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Thanks to its excellent R&D skills and six manufacturing facilities across Europe, EUROAPI guarantees API manufacturing of the highest quality to its clients in over 80 countries. Its strong innovation and R&D skills helps it to speed the development of more complex molecule segments through CDMO operations. It also offers experience in supply, regulation and quality. EUROAPI employs 3,350 people and is listed on Euronext.
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02

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  • fda
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Virtual BoothTransoPharm USA works in the Sourcing and Management of Active Pharmaceutical Ingredients.

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Digital Content Digital Content

Inclisiran

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...

Transo-Pharm, a fully licensed and certified distributor, specializes in pharmaceutical components for the health and veterinary industries. It offers support to clients throughout the entire API life cycle, from product development through sales. Transo-Pharm serves as a sourcing and regulatory marketing agent for API manufacturers. It aids clients in establishing DMFs and provides GMP consulting. With a dedicated regulatory department, a warehouse, proprietary IPs for API processes, and partnerships with laboratories, Transo-Pharm offers a wide range of services. It operates from its offices in Shanghai, Hong Kong, Singapore, and the US.
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03

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  • fda
  • EDQM
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Virtual BoothRibobay has expertise in oligonucleotides from siRNA, Antisense Oligonucleotides, miRNAs, and aptamers & Oligonucleotides CXOs.

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Digital Content Digital Content

Inclisiran

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...

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 Chuzhou, within the Nanjing metropolitan area, Ribobay Pharmaceutical specializes in the therapeutic oligonucleotides CXO field. This strategic focus aligns with General Biol's broader expansion plans for its CXO business, making Ribobay a crucial component of the company's ventures in this domain.
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04

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  • fda
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Virtual BoothOmgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.

Flag India
Digital Content Digital Content

Inclisiran

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...

Omgene Life Sciences Private Limited is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integrated company, we focus on developing high-quality formulations based on in-house-produced actives. With GMP-certified facilities and partnerships with contract manufacturers, we excel in formulation development for injectables, lyophilized injectables, complex generics, and oral peptide delivery systems, ensuring affordable, top-quality medicines.
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Inclisiran

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...

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 manufacturers who rely on our integrity, expertise, and follow-through have been with us for three, four, and even five decades.
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Inclisiran

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...

Sinopep leads the industry in therapeutic peptides, supplying top-demand APIs like Albuvirtide, Lanreotide, Semaglutide, and more. Renowned for high-quality peptide APIs and efficient manufacturing technologies, Sinopep ensures global compliance with advanced process development. Their CRDMO services span peptides, oligonucleotides, and synthetic conjugates, making them a trusted partner worldwide in pharmaceutical and healthcare solutions.
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Drugs in Development

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Details:

Leqvio (inclisiran), the first and only approved siRNA indicated in patients with low or moderate risk of developing atherosclerotic cardiovascular disease and not receiving lipid-lowering therapy.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 28, 2024

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Details : Leqvio (inclisiran), the first and only approved siRNA indicated in patients with low or moderate risk of developing atherosclerotic cardiovascular disease and not receiving lipid-lowering therapy.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

August 28, 2024

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Details:

Leqvio (inclisiran), approved in over 80 countries, is the first and only approved Small interfering RNA therapy with a successful synthesis of the antisense strand of this drug.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 09, 2024

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02

Biotech Digital Meet
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Details : Leqvio (inclisiran), approved in over 80 countries, is the first and only approved Small interfering RNA therapy with a successful synthesis of the antisense strand of this drug.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

July 09, 2024

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Details:

Leqvio (inclisiran), the first and only approved small interfering RNA therapy to lower LDL-C, gains expanded approval for adults with high LDL-C and who are at increased risk of heart disease.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 06, 2024

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03

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
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Details : Leqvio (inclisiran), the first and only approved small interfering RNA therapy to lower LDL-C, gains expanded approval for adults with high LDL-C and who are at increased risk of heart disease.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

April 06, 2024

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Details:

Leqvio (Inclisiran) is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 80 countries, including the US, EU and China.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 28, 2023

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04

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
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Details : Leqvio (Inclisiran) is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. It is approved in over 80 countries, including the US, EU and China.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

August 28, 2023

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Details:

Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 10, 2023

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05

Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
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Details : Leqvio (inclisiran), the first and only approved small interfering RNA (siRNA) therapy to lower LDL-C, gains expanded approval for the treatment of adults with high LDL-C and who are at increased risk of heart disease.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

July 10, 2023

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Details:

Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C and is administered with 2 doses a year. Leqvio is important for ASCVD patients who are not reaching recommended LDL-C target levels despite taking other cholesterol-lowering medications.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 07, 2022

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Biotech Digital Meet
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Details : Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C and is administered with 2 doses a year. Leqvio is important for ASCVD patients who are not reaching recommended LDL-C target levels despite taking other cholesterol-loweri...

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

November 07, 2022

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Details:

LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership July 26, 2022

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Soleo Health

U.S.A
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Soleo Health

U.S.A
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Details : LEQVIO (inclisiran) injection is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH).

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Undisclosed

July 26, 2022

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Details:

The approval of Leqvio (Inclisiran) First siRNA is based on the ability of Leqvio to lower LDL cholesterol up to 52% in patients with Atherosclerotic Cardiovascular Disease.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 22, 2021

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Biotech Digital Meet
Not Confirmed
Biotech Digital Meet
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Details : The approval of Leqvio (Inclisiran) First siRNA is based on the ability of Leqvio to lower LDL cholesterol up to 52% in patients with Atherosclerotic Cardiovascular Disease.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

December 22, 2021

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Details:

Treatment emergent adverse events (TEAEs) at the injection site were more frequent with Leqvio, but all were mild or moderate. The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.


Lead Product(s): Inclisiran,Ezetimibe

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Alnylam Pharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 08, 2021

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Biotech Digital Meet
Not Confirmed
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Details : Treatment emergent adverse events (TEAEs) at the injection site were more frequent with Leqvio, but all were mild or moderate. The effect of Leqvio on cardiovascular morbidity and mortality has not been determined.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

November 08, 2021

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Details:

Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England.


Lead Product(s): Inclisiran,Ezetimibe

Therapeutic Area: Genetic Disease Brand Name: Leqvio

Study Phase: Approved FDFProduct Type: Oligonucleotide

Sponsor: Novartis Pharmaceuticals Corporation

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration September 01, 2021

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NHS England

United Kingdom
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NHS England

United Kingdom
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Details : Agreement follows positive NICE recommendation and commits to deliver Leqvio® (inclisiran) access via a population health management approach identifying eligible patients across England.

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Undisclosed

September 01, 2021

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