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List of all Manufacturers, Suppliers & Exporters of Dronedarone API listed on PharmaCompass with details of regulatory filings

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01 ChemWerth Inc (1)

02 Jai Radhe Sales (1)

03 Sanofi (1)

04 LGM Pharma (1)

05 HRV Global Life Sciences (1)

06 ALP Pharm (1)

07 Acura Labs (1)

08 Alembic Pharmaceuticals Limited (2)

09 Alkem Laboratories (1)

10 Apotex Pharmachem (1)

11 Aspire Lifesciences Pvt Ltd (1)

12 Aurobindo Pharma Limited (1)

13 Aurore Life Sciences (1)

14 CHEMO (1)

15 Cambrex Corporation (1)

16 DEAFARMA (1)

17 Dalian Richon Chem (1)

18 Emcure Pharmaceuticals (1)

19 Enaltec Labs Private Limited (2)

20 Glenmark Life Sciences (1)

21 Glenmark Pharmaceuticals (1)

22 Guangzhou Tosun Pharmaceutical (1)

23 Haoyuan Chemexpress Co.Ltd (1)

24 Hoventa Pharma (1)

25 Jin Dun Medical (1)

26 Lupin Ltd (1)

27 MSN Laboratories (2)

28 Piramal Pharma Solutions (1)

29 Raks Pharma (1)

30 Sinopep Pharmaceutical Inc (1)

31 Sun Pharmaceutical Industries Limited (1)

32 Symed Labs (1)

33 Unimark Remedies Limited (1)

34 Viatris (1)

35 Wisdom Pharmaceutical Co., Ltd. (2)

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01 Canada (1)

02 China (8)

03 France (1)

04 India (22)

05 Italy (1)

06 Spain (1)

07 U.S.A (5)

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01 Active (19)

02 Inactive (3)

03 Blank (17)

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01 Valid (5)

02 Blank (34)

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01 Blank (39)

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01 WC-0021 (1)

02 WC-0021n (1)

03 WC-0049 (1)

04 WC-0057n (1)

05 WC-0072 (1)

06 WC-0082 (1)

07 WC-0082A5 (1)

08 WC-0119 (1)

09 WC-0170 (1)

10 WC-0424 (1)

11 Blank (29)

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USDMF

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Application Number
26479
Status
Active
Fees Paid
Reviewed
 
Filing Details
DRONEDARONE HYDROCHLORIDE NON-STERI...
Issue/Submission Date
2013-05-02
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Application Number
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Filing Details
Issue/Submission Date
Jai Radhe Sales

Festival of Biologics

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USDMF

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Application Number
18409
Status
Active
Fees Paid
N/A
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2005-06-08
Sanofi Company Banner

Festival of Biologics

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Application Number
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HRV Global Life Sciences Company Banner

Festival of Biologics

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USDMF

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Application Number
27161
Status
Active
Fees Paid
Reviewed
 
Filing Details
DRONEDARONE HYDROCHLORIDE USP
Issue/Submission Date
2013-05-31
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USDMF

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Application Number
25669
Indian CDSCO WC-0170
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-21
Filing Details
DRONEDARONE HYDROCHLORIDE
Dronedarone Hydrochloride (IH)
Issue/Submission Date
2012-02-16
2019-07-22
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USDMF

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Written Confirmation

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Application Number
26976
Indian CDSCO WC-0082
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-02
Filing Details
DRONEDARONE HYDROCHLORIDE USP
Dronedarone Hydrochloride
Issue/Submission Date
2013-03-26
2022-06-17
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USDMF

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Application Number
26963
Indian CDSCO WC-0049
Status
Active
Fees Paid
Reviewed
 
Valid
2025-06-16
Filing Details
DRONEDARONE HYDROCHLORIDE USP
Dronedarone Hydrochloride IH
Issue/Submission Date
2013-06-28
2022-06-07
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USDMF

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CEP/COS

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Application Number
35913
R0-CEP 2020-266 - Rev 01
Indian CDSCO WC-0119
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-02
Filing Details
DRONEDARONE HYDROCHLORIDE USP
Dronedarone hydrochloride
Dronedarone Hydrochloride Ph.Eur I...
Issue/Submission Date
2021-05-31
2023-04-27
2022-09-19
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USDMF

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Application Number
26593
CEP 2022-277 - Rev 00
Status
Active
Fees Unpaid
N/A
Valid
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Dronedarone hydrochloride
Issue/Submission Date
2012-12-23
2024-03-12
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USDMF

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Application Number
37247
Status
Active
Fees Unpaid
N/A
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2022-06-29
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USDMF

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Application Number
27223
Status
Active
Fees Paid
N/A
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-06-29
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USDMF

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Application Number
28200
Status
Active
Fees Unpaid
N/A
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2014-04-18
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USDMF

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Written Confirmation

Caution WC

Application Number
30229
Indian CDSCO WC-0072
Status
Active
Fees Paid
Reviewed
 
Expired
2022-09-08
Filing Details
DRONEDARONE HYDROCHLORIDE
Dronedarone Hydrochloride IH
Issue/Submission Date
2016-01-22
2019-10-07
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USDMF

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Application Number
27102
Status
Active
Fees Paid
Reviewed
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-05-13
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USDMF

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Application Number
31486
Status
Active
Fees Paid
N/A
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2017-03-29
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USDMF

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Application Number
26901
Status
Active
Fees Paid
Reviewed
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-03-26
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USDMF

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Application Number
26085
Indian CDSCO WC-0057n
Status
Active
Fees Unpaid
Reviewed
 
Valid
2025-06-25
Filing Details
DRONEDARONE HYDROCHLORIDE USP
Dronedarone Hydrochloride (1H)
Issue/Submission Date
2012-06-28
2022-06-07
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USDMF

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Application Number
31265
CEP 2020-051 - Rev 01
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
DRONEDARONE HYDROCHLORIDE USP
Dronedarone hydrochloride
Issue/Submission Date
2016-12-30
2024-01-16
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USDMF

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Application Number
26956
R0-CEP 2020-033 - Rev 00
Indian CDSCO WC-0021n
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-14
Filing Details
DRONEDARONE HYDROCHLORIDE USP [ROUT...
Dronedarone hydrochloride
Dronedarone Hydrochloride IH
Issue/Submission Date
2013-03-29
2022-08-09
2022-06-17
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USDMF

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Application Number
36931
Indian CDSCO WC-0021
Status
Active
Fees Paid
Reviewed
 
Expired
2022-07-14
Filing Details
DRONEDARONE HYDROCHLORIDE USP
Dronedarone Hydrochloride
Issue/Submission Date
2022-03-31
2019-07-15
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USDMF

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Application Number
27088
Status
Inactive
Fees Paid
N/A
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-05-08
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USDMF

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Application Number
27591
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
DRONEDARONE HYDROCHLORIDE
Issue/Submission Date
2013-10-30
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USDMF

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Application Number
Indian CDSCO WC-0082A5
Status
 
Expired
2022-07-02
Filing Details
Dronedarone HCl USP
Issue/Submission Date
2019-10-22
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Application Number
R0-CEP 2019-341 - Rev 00
Indian CDSCO WC-0424
Status
Valid
 
Expired
2021-07-09
Filing Details
Dronedarone hydrochloride
Dronedarone HCl IH
Issue/Submission Date
2023-04-11
2018-12-03
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Looking for 141625-93-6 / Dronedarone Hydrochloride API manufacturers, exporters & distributors?

Dronedarone Hydrochloride manufacturers, exporters & distributors 1

34

PharmaCompass offers a list of Dronedarone Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dronedarone Hydrochloride manufacturer or Dronedarone Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dronedarone Hydrochloride manufacturer or Dronedarone Hydrochloride supplier.

PharmaCompass also assists you with knowing the Dronedarone Hydrochloride API Price utilized in the formulation of products. Dronedarone Hydrochloride API Price is not always fixed or binding as the Dronedarone Hydrochloride Price is obtained through a variety of data sources. The Dronedarone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Dronedarone Hydrochloride

Synonyms

141625-93-6, Dronedarone hcl, N-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)methanesulfonamide hydrochloride, Dronedarone, hcl, Dronedarone (hydrochloride), Dronedarone hydrochloride [usan]

Cas Number

141625-93-6

Unique Ingredient Identifier (UNII)

FA36DV299Q

Dronedarone Manufacturers

A Dronedarone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dronedarone, including repackagers and relabelers. The FDA regulates Dronedarone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dronedarone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Dronedarone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Dronedarone Suppliers

A Dronedarone supplier is an individual or a company that provides Dronedarone active pharmaceutical ingredient (API) or Dronedarone finished formulations upon request. The Dronedarone suppliers may include Dronedarone API manufacturers, exporters, distributors and traders.

click here to find a list of Dronedarone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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