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List of Drug Master Files (KDMF) for Dronedarone Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 SANOFI CHIMIE@EUROAPI France (1)

02 SANOFI CHIMIE_x000D_ (1)

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01 Sanofi-Aventis Korea Co., Ltd. (2)

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01 Dronedarone hydrochloride (micronized) (1)

02 dronedarone hydrochloride (1)

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01 France (2)

URL Supplier Web Content
Sanofi-Aventis Korea Co., Ltd.
2009-09-24
3052-3-ND
SANOFI CHIMIE_x000D_
France
Route d'Avignon 30390 ARA...
URL Supplier Web Content
Sanofi-Aventis Korea Co., Ltd.
2009-09-24
3052-4-ND
SANOFI CHIMIE@EUROAPI Fra...
France
45 chemin de Meteline BP ...

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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Dronedarone Drug Master File in Korea (Dronedarone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dronedarone. The MFDS reviews the Dronedarone KDMF as part of the drug registration process and uses the information provided in the Dronedarone KDMF to evaluate the safety and efficacy of the drug.

After submitting a Dronedarone KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dronedarone API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Dronedarone suppliers with KDMF on PharmaCompass.

Dronedarone Manufacturers | Traders | Suppliers

Dronedarone Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Dronedarone

Get in contact with the supplier of your choice:

  1. EUROAPI
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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