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List of Drug Master Files (DMF) of Dronedarone Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 ChemWerth Inc (1)

02 Sanofi (1)

03 ALP Pharm (1)

04 Alembic Pharmaceuticals Limited (1)

05 Alkem Laboratories (1)

06 Apotex Pharmachem (1)

07 Aurobindo Pharma Limited (1)

08 Aurore Life Sciences (1)

09 Emcure Pharmaceuticals (1)

10 Glenmark Life Sciences (1)

11 Lupin Ltd (1)

12 MSN Laboratories (2)

13 Piramal Pharma Solutions (1)

14 Raks Pharma (1)

15 Sinopep Pharmaceutical Inc (1)

16 Sun Pharmaceutical Industries Limited (1)

17 Symed Labs (1)

18 Unimark Remedies Limited (1)

19 Viatris (1)

20 Wisdom Pharmaceutical Co., Ltd. (2)

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01 DRONEDARONE HYDROCHLORIDE (13)

02 DRONEDARONE HYDROCHLORIDE NON-STERILE BULK DRUG (1)

03 DRONEDARONE HYDROCHLORIDE USP (7)

04 DRONEDARONE HYDROCHLORIDE USP [ROUTE CODE-DD] (1)

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01 Canada (1)

02 China (4)

03 France (1)

04 India (13)

05 U.S.A (3)

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01 Active (19)

02 Inactive (3)

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01 Complete (12)

02 Blank (10)

URL Supplier Web Content
18409
Active
2005-06-08
N/A
II
Sanofi Company Banner

Iran Expo

Not Confirmed

envelop Contact Supplier
URL Supplier Web Content
26976
Active
2013-03-26
Complete
2013-07-19
2013-06-24
II
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URL Supplier Web Content
26901
Active
2013-03-26
Complete
2013-07-11
2013-04-08
II
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URL Supplier Web Content
26085
Active
2012-06-28
Complete
2013-11-12
2013-05-24
II
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URL Supplier Web Content
26963
Active
2013-06-28
Complete
2013-07-19
2013-06-19
II
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URL Supplier Web Content
26956
Active
2013-03-29
Complete
2013-09-27
2013-04-03
II
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URL Supplier Web Content
27102
Active
2013-05-13
Complete
2013-06-28
2013-05-02
II
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URL Supplier Web Content
25669
Active
2012-02-16
Complete
2013-07-30
2013-06-24
II
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URL Supplier Web Content
26593
Active
2012-12-23
N/A
II
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Looking for 141625-93-6 / Dronedarone Hydrochloride API manufacturers, exporters & distributors?

Dronedarone Hydrochloride manufacturers, exporters & distributors 1

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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.

Dronedarone USDMF

A Dronedarone DMF (Drug Master File) is a document detailing the whole manufacturing process of Dronedarone active pharmaceutical ingredient (API) in detail. Different forms of Dronedarone DMFs exist exist since differing nations have different regulations, such as Dronedarone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Dronedarone DMF submitted to regulatory agencies in the US is known as a USDMF. Dronedarone USDMF includes data on Dronedarone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dronedarone USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Dronedarone suppliers with USDMF 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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