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ACTIVE PHARMA INGREDIENTS

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Chemistry

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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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INCLISIRAN SODIUM

NDC Package Code : 42931-712

Start Marketing Date : 2024-11-26

End Marketing Date : 2025-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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EUROAPI

France
  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content

Inclisiran

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 ...

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 200 products in our portfolio, offering a large span of technologies while developing innovative molecules through our CDMO activities. Taking action for health by enabling access to essential therapies inspires our 3,650 people every day. With strong research and development capabilities and six manufacturing sites, all located in Europe, EUROAPI ensures API manufacturing of the highest quality to supply customers in more than 80 countries.
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02

  • fda
  • EDQM
  • WHO-GMP

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

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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

  • fda
  • EDQM
  • WHO-GMP

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

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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

  • fda
  • EDQM
  • WHO-GMP

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

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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05

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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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API Reference Price

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21-Jun-2024
21-May-2025
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Drugs in Development

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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 September 07, 2024

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01

Indo Livestock Expo
Not Confirmed
Indo Livestock Expo
Not Confirmed

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

September 07, 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.


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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02

Indo Livestock Expo
Not Confirmed
Indo Livestock Expo
Not Confirmed

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), 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 June 04, 2024

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03

Indo Livestock Expo
Not Confirmed
Indo Livestock Expo
Not Confirmed

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

June 04, 2024

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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 October 07, 2023

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04

Indo Livestock Expo
Not Confirmed
Indo Livestock Expo
Not Confirmed

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

October 07, 2023

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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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05

Indo Livestock Expo
Not Confirmed
Indo Livestock Expo
Not Confirmed

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) 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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Indo Livestock Expo
Not Confirmed

Soleo Health

U.S.A
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Indo Livestock Expo
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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:

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 July 11, 2022

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07

Indo Livestock Expo
Not Confirmed
Indo Livestock Expo
Not Confirmed

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

July 11, 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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08

Indo Livestock Expo
Not Confirmed
Indo Livestock Expo
Not Confirmed

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:

Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly Leqvio® (inclisiran) consistently reduced LDL-C in patients with atherosclerotic cardiovascular disease with established cerebrovascular disease and polyvascular disease.


Lead Product(s): Inclisiran

Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Leqvio

Study Phase: Phase IIIProduct Type: Oligonucleotide

Sponsor: Alnylam Pharmaceuticals

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable August 31, 2021

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09

Indo Livestock Expo
Not Confirmed
Indo Livestock Expo
Not Confirmed

Details : Separate post hoc analyses of pooled Phase III ORION-9, -10 and -11 data show twice-yearly Leqvio® (inclisiran) consistently reduced LDL-C in patients with atherosclerotic cardiovascular disease with established cerebrovascular disease and polyvascular ...

Product Name : Leqvio

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

August 31, 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 August 11, 2021

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Indo Livestock Expo
Not Confirmed
Indo Livestock Expo
Not Confirmed

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

August 11, 2021

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FDF Dossiers

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INCLISIRAN SODIUM

Brand Name : LEQVIO

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)

Packaging :

Approval Date : 2021-12-22

Application Number : 214012

Regulatory Info : RX

Registration Country : USA

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Inclisiranum

Brand Name : Leqvio

Dosage Form : Inj L?s

Dosage Strength : 284mg/1.5ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Inclisiranum

Brand Name : Leqvio

Dosage Form : Inj L?s

Dosage Strength : 284mg/1.5ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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inclisiran

Brand Name : Leqvio

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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inclisiran

Brand Name : Leqvio

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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FDA Orange Book

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NOVARTIS

Switzerland
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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

Brand Name : LEQVIO

Dosage Form : SOLUTION;SUBCUTANEOUS

Dosage Strength : EQ 284MG BASE/1.5ML (EQ 189MG BASE/ML)

Approval Date : 2021-12-22

Application Number : 214012

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Europe

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Inclisiranum

Brand Name : Leqvio

Dosage Form : Inj L?s

Dosage Strength : 284mg/1.5ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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02

Indo Livestock Expo
Not Confirmed
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Indo Livestock Expo
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Inclisiranum

Brand Name : Leqvio

Dosage Form : Inj L?s

Dosage Strength : 284mg/1.5ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Australia

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Novartis Pharmaceuticals Australia Pty L...

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Novartis Pharmaceuticals Australia Pty L...

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inclisiran

Brand Name : Leqvio

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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Novartis Pharmaceuticals Australia Pty L...

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Indo Livestock Expo
Not Confirmed
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Novartis Pharmaceuticals Australia Pty L...

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inclisiran

Brand Name : Leqvio

Dosage Form :

Dosage Strength :

Packaging : 1

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Australia

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