Dronedarone Hydrochloride | FDA Orange Book | Approved Drug Product List | PharmaCompass.com

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Dronedarone Hydrochloride
FDA Orange Book

Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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Jai Radhe Sales is your partner for all your sourcing needs.

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xyz-pharma-m-2024-10-07

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Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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xyz-pharma-m-2024-10-07

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Dronedarone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 22 USDMF, 5 CEP/COS, 10 EU WC, 2 KDMF, 7 NDC API, 23 Listed Suppliers, $ API Reference Price

39 API Suppliers
22 USDMF
5 CEP/COS
10 EU WC
2 KDMF
7 NDC API
23 Listed Suppliers
$ API Reference Price

INTERMEDIATES

22 Intermediates Suppliers

22 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

19 FDF Dossiers, 8 FDA Orange Book, 7 Europe, 1 Canada, 3 Listed Dossiers

19 FDF Dossiers
8 FDA Orange Book
7 Europe
1 Canada
3 Listed Dossiers

RELATED EXCIPIENT COMPANIES

3 SPI Pharma, 3 DKSH, 3 Faran Shimi Pharmaceutical, 8 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 10 Corel Pharma Chem, 2 DFE Pharma, 5 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 26 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 8 Microlex e.U, 1 Nanjing Bold Chemical, 1 Novo Excipients, 3 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 8 Roquette, 7 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Sigachi Industries, 2 The Dow Chemical Company, 1 Vasa Pharmachem

3 SPI Pharma
3 DKSH
3 Faran Shimi Pharmaceutical
8 Gangwal Healthcare
3 Nanjing Well Pharmaceutical
1 ACG Worldwide
4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
2 BASF
10 Corel Pharma Chem
2 DFE Pharma
5 Gangwal Chemicals
4 Ideal Cures Pvt Ltd
2 Ingredion Pharma Solutions
26 Kerry
3 Kima Chemical
6 Lonza Capsugel
8 Microlex e.U
1 Nanjing Bold Chemical
1 Novo Excipients
3 Pluviaendo
1 Prachin Chemical
1 Qianhao Chemical (Hebei) Co., Ltd
1 Qualicaps
8 Roquette
7 Seppic
3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd
3 Sigachi Industries
2 The Dow Chemical Company
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

43 Fillers, Diluents & Binders, 42 Coating Systems & Additives, 18 Direct Compression, 17 Controlled & Modified Release, 12 Lubricants & Glidants, 9 Co-Processed Excipients, 8 Film Formers & Plasticizers, 8 Granulation, 7 Thickeners and Stabilizers, 5 Chewable & Orodispersible Aids, 5 Disintegrants & Superdisintegrants, 5 Empty Capsules, 5 Taste Masking, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Coloring Agents, 4 Solubilizers, 4 Emulsifying Agents, 3 Topical, 2 Parenteral, 1 Rheology Modifiers

43 Fillers, Diluents & Binders
42 Coating Systems & Additives
18 Direct Compression
17 Controlled & Modified Release
12 Lubricants & Glidants
9 Co-Processed Excipients
8 Film Formers & Plasticizers
8 Granulation
7 Thickeners and Stabilizers
5 Chewable & Orodispersible Aids
5 Disintegrants & Superdisintegrants
5 Empty Capsules
5 Taste Masking
4 Vegetarian Capsules
4 API Stability Enhancers
4 Coloring Agents
4 Solubilizers
4 Emulsifying Agents
3 Topical
2 Parenteral
1 Rheology Modifiers

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 5 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
5 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 Finished Drug Prices, 5 Annual Reports

6 Finished Drug Prices
5 Annual Reports

MARKET PLACE

4 APIs, 1 FDF Dossiers

4 APIs
1 FDF Dossiers

PATENTS & EXCLUSIVITIES

5 US Patents, 2 Health Canada Patents

5 US Patents
2 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 USP, 6 Others

5 USP
6 Others

$ API Ref.Price (USD/KG) : 495 Xls

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01 1SANOFI AVENTIS US

02 1ALKEM LABS LTD

03 1AMNEAL PHARMS

04 1AUROBINDO PHARMA LTD

05 1GLENMARK GENERICS

06 1LUPIN

07 1SANDOZ INC

08 1WATSON LABS INC

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8 All

01 8TABLET;ORAL

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8 All

01 2RX

02 6Blank

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8 All

01 2DRONEDARONE

02 5DRONEDARONE HYDROCHLORIDE

03 1MULTAQ

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8 All

01 1No

02 1Yes

03 6Blank

List of Suppliers

Product Main Page

01

SANOFI AVENTIS US

CPhI India 2024

Not Confirmed

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

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Digital Content

RLD : Yes

TE Code : AB

DRONEDARONE HYDROCHLORIDE

Brand Name : MULTAQ

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 2009-07-01

Application Number : 22425

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Sanofi Company Banner

Portfolio PDF

Product Web Link

Digital Content

02

WATSON LABS INC

CPhI India 2024

Not Confirmed

WATSON LABS INC

CPhI India 2024

Not Confirmed

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RLD :

TE Code :

DRONEDARONE HYDROCHLORIDE

Brand Name : DRONEDARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date :

Application Number : 205682

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

ALKEM LABS LTD

CPhI India 2024

Not Confirmed

ALKEM LABS LTD

CPhI India 2024

Not Confirmed

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RLD :

TE Code :

DRONEDARONE HYDROCHLORIDE

Brand Name : DRONEDARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date :

Application Number : 205895

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Digital Content

Corporate PDF

04

AMNEAL PHARMS

CPhI India 2024

Not Confirmed

AMNEAL PHARMS

CPhI India 2024

Not Confirmed

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Digital Content

RLD :

TE Code :

DRONEDARONE

Brand Name : DRONEDARONE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date :

Application Number : 206649

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

AUROBINDO PHARMA LTD

CPhI India 2024

Not Confirmed

AUROBINDO PHARMA LTD

CPhI India 2024

Not Confirmed

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Digital Content

RLD :

TE Code :

DRONEDARONE

Brand Name : DRONEDARONE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date :

Application Number : 210678

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

06

GLENMARK GENERICS

CPhI India 2024

Not Confirmed

GLENMARK GENERICS

CPhI India 2024

Not Confirmed

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RLD :

TE Code :

DRONEDARONE HYDROCHLORIDE

Brand Name : DRONEDARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date :

Application Number : 205903

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

LUPIN

CPhI India 2024

Not Confirmed

LUPIN

CPhI India 2024

Not Confirmed

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Digital Content

RLD : No

TE Code : AB

DRONEDARONE HYDROCHLORIDE

Brand Name : DRONEDARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 2024-01-31

Application Number : 205904

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Product Web Link

Digital Content

Corporate PDF

08

SANDOZ INC

CPhI India 2024

Not Confirmed

SANDOZ INC

CPhI India 2024

Not Confirmed

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Digital Content

RLD :

TE Code :

DRONEDARONE HYDROCHLORIDE

Brand Name : DRONEDARONE HYDROCHLORIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG

Approval Date :

Application Number : 205744

RX/OTC/DISCN :

RLD :

TE Code :

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Digital Content

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