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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)

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$ 0

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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01

EUROAPI

France

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

  • fda
  • EDQM
  • WHO-GMP

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

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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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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BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content
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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BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

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Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Ribobay-Company-Banner

04

Omgene Life Sciences Pvt. Ltd

India

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

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BIO Partnering at JPM
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

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

Sinopep Pharmaceutical Inc

China

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

BIO Partnering at JPM
Not Confirmed
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06

Gyma Laboratories of America

U.S.A

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

BIO Partnering at JPM
Not Confirmed
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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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BIO Partnering at JPM
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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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01

BIO Partnering at JPM
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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
  • 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 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.
EUROAPI Compnay Banner

02

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Biotech Showcase
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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.
Transo Pharm USA Company Banner

03

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Biotech Showcase
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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

Flag China
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.
Ribobay-Company-Banner

04

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Biotech Showcase
Not Confirmed
  • fda
  • EDQM
  • WHO-GMP

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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05

Biotech Showcase
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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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06

Biotech Showcase
Not Confirmed
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Inclisiran

About the Company : Sinopep-Allsino Biopharmaceutical Co Ltd.is a biomedical enterprise with the main business of research and development, production, sales and technical services of peptides and sma...

Sinopep-Allsino Biopharmaceutical Co Ltd.is a biomedical enterprise with the main business of research and development, production, sales and technical services of peptides and small molecule drugs. The company is a national high-tech enterprise and provincial science and technology enterprise, established in April 2009, located in the national Lianyungang Economic and Technological Development Zone. The company was listed on the New Third Board in January 2016 (Stock Abbreviation: Sinopep Biology, Code: 835572).There are more than 800 employees.
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FDA Orange Book

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01

NOVARTIS

Switzerland
BIO Partnering at JPM
Not Confirmed
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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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Digital Content read-more

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DATA COMPILATION #PharmaFlow

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NEWS #PharmaBuzz

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Global Sales Information

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Annual Reports

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01

Brand Name : Leqvio

Inclisiran

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Brand Name : Leqvio

Switzerland
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Inclisiran

Main Therapeutic Indication : Cardiovascular Diseases

Currency : USD

2021 Revenue in Millions : 12

2020 Revenue in Millions : 0

Growth (%) : New Launch in 2021

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02

Brand Name : Leqvio

Inclisiran

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BIO Partnering at JPM
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Brand Name : Leqvio

Switzerland
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BIO Partnering at JPM
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Inclisiran

Main Therapeutic Indication : Cardiology/Vascular Diseases

Currency : USD

2022 Revenue in Millions : 112

2021 Revenue in Millions : 12

Growth (%) : 833

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03

Brand Name : Leqvio

Inclisiran

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BIO Partnering at JPM
Not Confirmed

Brand Name : Leqvio

Switzerland
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BIO Partnering at JPM
Not Confirmed

Inclisiran

Main Therapeutic Indication : Cardiology/Vascular Diseases

Currency : USD

2023 Revenue in Millions : 355

2022 Revenue in Millions : 112

Growth (%) : 217

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Market Place

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Patents & EXCLUSIVITIES

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US Patents

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01

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NOVARTIS

Switzerland
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INCLISIRAN SODIUM

US Patent Number : 10669544

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 214012

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2024-03-08

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02

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BIO Partnering at JPM
Not Confirmed

NOVARTIS

Switzerland
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BIO Partnering at JPM
Not Confirmed

INCLISIRAN SODIUM

US Patent Number : 8828956

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214012

Patent Use Code : U-3652

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-12-04

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03

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BIO Partnering at JPM
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NOVARTIS

Switzerland
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BIO Partnering at JPM
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INCLISIRAN SODIUM

US Patent Number : 10273477

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 214012

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2024-03-08

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BIO Partnering at JPM
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NOVARTIS

Switzerland
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BIO Partnering at JPM
Not Confirmed

INCLISIRAN SODIUM

US Patent Number : 8809292

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214012

Patent Use Code : U-3652

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-05-10

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BIO Partnering at JPM
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NOVARTIS

Switzerland
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BIO Partnering at JPM
Not Confirmed

INCLISIRAN SODIUM

US Patent Number : 8222222

Drug Substance Claim :

Drug Product Claim :

Application Number : 214012

Patent Use Code : U-3652

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-12-29

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BIO Partnering at JPM
Not Confirmed

NOVARTIS

Switzerland
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BIO Partnering at JPM
Not Confirmed

INCLISIRAN SODIUM

US Patent Number : 8106022

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214012

Patent Use Code : U-3652

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-12-12

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BIO Partnering at JPM
Not Confirmed

NOVARTIS

Switzerland
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BIO Partnering at JPM
Not Confirmed

INCLISIRAN SODIUM

US Patent Number : 10806791

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 214012

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-12-04

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BIO Partnering at JPM
Not Confirmed

NOVARTIS

Switzerland
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BIO Partnering at JPM
Not Confirmed

INCLISIRAN SODIUM

US Patent Number : 10851377

Drug Substance Claim :

Drug Product Claim :

Application Number : 214012

Patent Use Code : U-3652

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2036-08-25

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09

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BIO Partnering at JPM
Not Confirmed

NOVARTIS

Switzerland
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BIO Partnering at JPM
Not Confirmed

INCLISIRAN SODIUM

US Patent Number : 11530408

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 214012

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2024-05-18

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10

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BIO Partnering at JPM
Not Confirmed

NOVARTIS

Switzerland
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BIO Partnering at JPM
Not Confirmed

INCLISIRAN SODIUM

US Patent Number : 10131907

Drug Substance Claim : Y

Drug Product Claim : Y

Application Number : 214012

Patent Use Code : U-3652

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2028-08-24

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