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Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

USDMF

US DMFs Filed

0

CEP/COS

CEP/COS Certifications

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EU WC

EU WC

0

KDMF

KDMF

0

NDC API

NDC API

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VMF

NDC API

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

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US Patents

0

US Exclusivities

API REF. PRICE (USD/KG)

$
$ 0

GLOBAL SALES INFORMATION

Regulatory FDF Prices

NA

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MARKET PLACE

0

FDF

Chemistry

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API SUPPLIERS

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01

Shanghai Minbiotech

China

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

Flag China
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
Shanghai Minbiotech CB

02

Beijing Mesochem Technology

China

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

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMesochem is focused on incessant innovation along with the R&D of new APIs.

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

03

Regeneron Pharmaceuticals

U.S.A

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

ISPE Annual Meeting
Not Confirmed
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Regeneron Pharmaceuticals

U.S.A

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

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ISPE Annual Meeting
Not Confirmed
USDMF CEP/COS JDMF arrow-down EU-WC NDC KDMF VMF Others AUDIT
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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothShanghai Minbiotech is the leading producer of biopharmaceuticals and a variety of high-end generic & innovative drugs.

Flag China
Digital Content Digital Content

Dupilumab

About the Company : ​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological API...

​Headquartered in Fengxian District, Shanghai Minbiotech Co., Ltd. is a company specializing in the R&D and production of advanced pharmaceutical intermediates and biological APIs. There are more than 1000 square meters of R&D centers in Nantong, Jiangsu and Jinan, Shandong, with more than 13,000㎡ of production sites. While supplying products to customers, the company also provides services such as technology development, technology transfer and technology exchange, aiming to provide customers with comprehensive supply and solutions in the biomedical industry.
Shanghai Minbiotech CB

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothMesochem is focused on incessant innovation along with the R&D of new APIs.

Flag China
Digital Content Digital Content

Dupilumab

About the Company : Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine c...

Beijing Mesochem Technology Co. Ltd., which is located in the national economic and technological development area of Yizhuang, China, manufactures pharmaceutical chemicals, fine chemicals and fundamental chemical materials. It has an efficient research and development team. Beijing Mesochem provides its customers customized development, craft optimization, contract customization and outsourcing services. The company has a well-established industrial base in Weinan, Shanxi Province. The production base features a 20,000 ㎡ plant with a production capacity of over 8,000 MT per year.
Mesochem Company Banner
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FDF Dossiers

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01

Sanofi

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dupilumab

Brand Name : Dupixent

Dosage Form : Solution For Injection

Dosage Strength : 200mg

Packaging :

Approval Date : 06/05/2019

Application Number : 20180307000072

Regulatory Info : Approved

Registration Country : Sweden

Sanofi Company Banner

02

Sanofi

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dupilumab

Brand Name : Dupixent

Dosage Form : Solution For Injection

Dosage Strength : 200mg

Packaging :

Approval Date : 06/05/2019

Application Number : 20180307000065

Regulatory Info : Approved

Registration Country : Sweden

Sanofi Company Banner

03

Sanofi

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dupilumab

Brand Name : Dupixent

Dosage Form : Solution For Injection

Dosage Strength : 300mg

Packaging :

Approval Date : 17/10/2019

Application Number : 20191129000010

Regulatory Info : Approved

Registration Country : Sweden

Sanofi Company Banner

04

Sanofi

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Approved

Registration Country : Sweden

Dupilumab

Brand Name : Dupixent

Dosage Form : Solution For Injection

Dosage Strength : 300mg

Packaging :

Approval Date : 26/09/2017

Application Number : 20161109000064

Regulatory Info : Approved

Registration Country : Sweden

Sanofi Company Banner

05

Sanofi

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Deregistered

Registration Country : Sweden

Dupilumab

Brand Name : Dupixent

Dosage Form : Solution For Injection

Dosage Strength : 100mg

Packaging :

Approval Date : 04/04/2022

Application Number : 20210308000020

Regulatory Info : Deregistered

Registration Country : Sweden

Sanofi Company Banner

06

Sanofi

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Schedule D

Registration Country : Canada

DUPILUMAB

Brand Name : DUPIXENT

Dosage Form : SOLUTION

Dosage Strength : 300MG/2ML

Packaging : 2ML

Approval Date :

Application Number : 2470365

Regulatory Info : Schedule D

Registration Country : Canada

Sanofi Company Banner

07

Sanofi

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Prescription

Registration Country : Canada

DUPILUMAB

Brand Name : DUPIXENT

Dosage Form : SOLUTION

Dosage Strength : 200MG/1.14ML

Packaging :

Approval Date :

Application Number : 2492504

Regulatory Info : Prescription

Registration Country : Canada

Sanofi Company Banner

08

Sanofi

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Schedule D

Registration Country : Canada

DUPILUMAB

Brand Name : DUPIXENT

Dosage Form : SOLUTION

Dosage Strength : 300MG/2ML

Packaging :

Approval Date :

Application Number : 2510049

Regulatory Info : Schedule D

Registration Country : Canada

Sanofi Company Banner

09

Sanofi

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Prescription

Registration Country : Canada

DUPILUMAB

Brand Name : DUPIXENT

Dosage Form : SOLUTION

Dosage Strength : 200MG/1.14ML

Packaging :

Approval Date :

Application Number : 2524252

Regulatory Info : Prescription

Registration Country : Canada

Sanofi Company Banner

10

Sanofi

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

Flag France
Digital Content Digital Content

Regulatory Info : Originator

Registration Country : South Africa

Dupilumab

Brand Name : Dupixent 200mg

Dosage Form : INJ

Dosage Strength : 200mg

Packaging : 1.14X2mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Sanofi Company Banner
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FDA Orange Book

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01

ISPE Annual Meeting
Not Confirmed
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ISPE Annual Meeting
Not Confirmed

DUPILUMAB

Brand Name : DUPIXENT

Dosage Form : INJECTABLE; INJECTION

Dosage Strength : 150MG/ML

Approval Date :

Application Number : 761055

RX/OTC/DISCN :

RLD :

TE Code :

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Patents & EXCLUSIVITIES

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