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

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Dronedarone Hydrochloride
FDA Orange Book

SPI Pharma has been solving formulation challenges using superior functional materials.

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Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Chirogate is a professional Prostaglandin manufacturer.

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Temad- We think of world-class quality.

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Dronedarone Hydrochloride

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

40 API Suppliers, 22 USDMF, 5 CEP/COS, 10 EU WC, 7 NDC API, 24 Listed Suppliers, $ API Reference Price

40 API Suppliers
22 USDMF
5 CEP/COS
10 EU WC
7 NDC API
24 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

24 Intermediate Suppliers

24 Intermediate 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, 5 DKSH, 3 Faran Shimi Pharmaceutical, 2 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, 1 Silverline Chemicals, 2 The Dow Chemical Company, 1 Vasa Pharmachem

3 SPI Pharma
5 DKSH
3 Faran Shimi Pharmaceutical
2 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
1 Silverline Chemicals
2 The Dow Chemical Company
1 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

42 Coating Systems & Additives, 39 Fillers, Diluents & Binders, 16 Controlled & Modified Release, 12 Lubricants & Glidants, 11 Direct Compression, 8 Granulation, 8 Thickeners and Stabilizers, 8 Film Formers & Plasticizers, 5 Empty Capsules, 5 Taste Masking, 5 Chewable & Orodispersible Aids, 5 Co-Processed Excipients, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Coloring Agents, 4 Solubilizers, 4 Emulsifying Agents, 4 Disintegrants & Superdisintegrants, 3 Topical, 3 Rheology Modifiers, 2 Parenteral

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

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 5 News #PharmaBuzz

1 Data Compilation #PharmaFlow
5 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 Regulatory FDF Prices, 5 Annual Reports

6 Regulatory FDF 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

6 Others

6 Others

$ API Ref.Price (USD/KG) : 456 Xls

Filters

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8 All

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

filter Dosage Reset all filters

8 All

01 8TABLET;ORAL

filter Regulatory Info Reset all filters

8 All

01 2RX

02 6Blank

filter Brand Name Reset all filters

8 All

01 2DRONEDARONE

02 5DRONEDARONE HYDROCHLORIDE

03 1MULTAQ

filter RLD Reset all filters

8 All

01 1No

02 1Yes

03 6Blank

List of Suppliers

Product Main Page

01

SANOFI AVENTIS US

BIO International Convention

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

Contact Supplier

Contact Supplier

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

STLE Annual Meeting

Not Confirmed

WATSON LABS INC

STLE Annual Meeting

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 : 205682

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

ALKEM LABS LTD

STLE Annual Meeting

Not Confirmed

ALKEM LABS LTD

STLE Annual Meeting

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 : 205895

RX/OTC/DISCN :

RLD :

TE Code :

Product Web Link

Digital Content

Corporate PDF

04

AMNEAL PHARMS

STLE Annual Meeting

Not Confirmed

AMNEAL PHARMS

STLE Annual Meeting

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

STLE Annual Meeting

Not Confirmed

AUROBINDO PHARMA LTD

STLE Annual Meeting

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

STLE Annual Meeting

Not Confirmed

GLENMARK GENERICS

STLE Annual Meeting

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 : 205903

RX/OTC/DISCN :

RLD :

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

LUPIN

STLE Annual Meeting

Not Confirmed

LUPIN

STLE Annual Meeting

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

STLE Annual Meeting

Not Confirmed

SANDOZ INC

STLE Annual Meeting

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

Post an Enquiry

Post an Enquiry

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 :

Product Web Link

Digital Content

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