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ACTIVE PHARMA INGREDIENTS

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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

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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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Inclisiran

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...

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 of around 200 products, covering a wide range of technologies and innovative molecules through CDMO activities. Supported by 3,650 employees, strong R&D capabilities, and six manufacturing sites in Europe, EUROAPI delivers high-quality API manufacturing to customers in more than 80 countries. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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02

  • fda
  • EDQM
  • WHO-GMP

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

Flag U.S.A
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Inclisiran

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...

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 acts as a sourcing and regulatory marketing agent for API manufacturers. Transo-Pharm assists with DMF setup, GMP consulting, and regulatory activities, supported by a regulatory team, warehouse facilities, proprietary API process IPs, and laboratory partnerships, with offices in Shanghai, Hong Kong, Singapore, and the US. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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03

  • 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 Pvt. Ltd. is an R&D-driven biopharmaceutical company specializing in biopharmaceuticals, peptides, semi-synthetic, and synthetic actives. As a vertically integ...

Omgene Life Sciences Pvt. Ltd. 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. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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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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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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PU DONG","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"0.30","actualQuantity":"0.3","unit":"KGS","unitRateFc":"1090000","totalValueFC":"330813.2","currency":"USD","unitRateINR":"94394000","date":"16-Apr-2025","totalValueINR":"28318200","totalValueInUsd":"330813.2","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"9512789","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"ROOM 1101, BUILDING A, NO.58,TANZHU ROAD, SHANGHAI, SDNF CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1746729000,"product":"INCLISIRAN SODIUM (LIST 4 SR.NO.148) INCLISIRAN SODIUM (LIST 4 SR.NO.148)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"SHANGHAI AURISCO BIOTECH COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"0.05","actualQuantity":"48.1","unit":"GMS","unitRateFc":"500","totalValueFC":"24148.6","currency":"USD","unitRateINR":"42775","date":"09-May-2025","totalValueINR":"2057477.5","totalValueInUsd":"24148.6","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"9962677","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":"ROOM 1101, BUILDING A, NO.58,TANZHU ROAD, SHANGHAI, SDNF CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q2","strtotime":1747765800,"product":"INCLISIRAN SODIUM (LIST 4 SR.NO.148) INCLISIRAN SODIUM (LIST 4 SR.NO.148)","address":"MUMBAI CENTRAL,","city":"MUMBAI, MAHARASHTRA.","supplier":"YANGZHOU AURISCO PHARMACEUTICAL CO","supplierCountry":"CHINA","foreign_port":"SHANGHAI - PU DONG","customer":"CIPLA LTD","customerCountry":"INDIA","quantity":"0.50","actualQuantity":"500","unit":"GMS","unitRateFc":"680","totalValueFC":"344786.1","currency":"USD","unitRateINR":"58752","date":"21-May-2025","totalValueINR":"29376000","totalValueInUsd":"344786.1","indian_port":"Bombay Air","hs_no":"29349990","bill_no":"2187525","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI - PU DONG","supplierAddress":", LTD.NO.28,JIANAN ROAD,HIGH-TECHIN DUSTRIAL DEVELOPMENT ZONE,YANGZHOUC ITY,JIANGSU PROVINCE 225100, P.R. CHINA","customerAddress":"MUMBAI CENTRAL,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1754073000,"product":"INCLISIRAN (AP1) INCLISIRAN (AP1)","address":"NO.1-1-385\/A, 307,","city":"HYDERABAD, AP.","supplier":"HANGZHOU APEXTIDE BIOMEDICAL TECHNOLOGY CO,LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"INVITRON ADVANCED ANALYTICS PRIVATE LTD","customerCountry":"INDIA","quantity":"0.00","actualQuantity":"1","unit":"GMS","unitRateFc":"5000","totalValueFC":"4958.9","currency":"USD","unitRateINR":"434000","date":"02-Aug-2025","totalValueINR":"434000","totalValueInUsd":"4958.9","indian_port":"Hyderabad Air","hs_no":"29371900","bill_no":"3648442","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"BUILDING 14,YINHAI KECHUANG CENTER NO.501 FUCHENG ROAD XIASHA STREET QIANTANG DISTRICT HANGZHOU CITY CN","customerAddress":"NO.1-1-385\/A, 307,"}]
28-Oct-2024
02-Aug-2025
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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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Inclisiran

Brand Name : Leqvio

Dosage Form : Solution For Injection

Dosage Strength : 284mg/1.5ml

Packaging :

Approval Date :

Application Number :

Regulatory Info : Prescription

Registration Country : Estonia

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INCLISIRAN (INCLISIRAN SODIUM)

Brand Name : LEQVIO

Dosage Form : SOLUTION

Dosage Strength : 284MG/1.5ML

Packaging :

Approval Date :

Application Number : 2518376

Regulatory Info : Prescription

Registration Country : Canada

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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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Inclisiran

Brand Name : Leqvio

Dosage Form : Solution For Injection

Dosage Strength : 284mg

Packaging :

Approval Date : 09-12-2020

Application Number : 28106393820

Regulatory Info : Prescription

Registration Country : Denmark

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