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List of Certificates of Suitability (CEPs) for Dronedarone Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 APITORIA PHARMA PRIVATE LIMITED Hyderabad IN (1)

02 AURORE LIFE SCIENCES PRIVATE LIMITED Hyderabad IN (1)

03 ENALTEC LABS PRIVATE LIMITED Navi Mumbai IN (1)

04 MSN LABORATORIES PRIVATE LIMITED Rudraram Village IN (1)

05 Wisdom Pharmaceutical Co., Ltd. Haimen CN (1)

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01 Dronedarone hydrochloride (5)

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01 China (1)

02 India (4)

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01 Valid (5)

URL Supplier Web Content
CEP 2020-051 - Rev 01
Valid
Chemical
2024-01-16
3039
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R0-CEP 2020-266 - Rev 01
Valid
Chemical
2023-04-27
3039
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R0-CEP 2019-341 - Rev 00
Valid
Chemical
2023-04-11
3039
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R0-CEP 2020-033 - Rev 00
Valid
Chemical
2022-08-09
3039
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CEP 2022-277 - Rev 00
Valid
Chemical
2024-03-12
3039
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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 CEP

A Dronedarone CEP of the European Pharmacopoeia monograph is often referred to as a Dronedarone Certificate of Suitability (COS). The purpose of a Dronedarone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Dronedarone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Dronedarone to their clients by showing that a Dronedarone CEP has been issued for it. The manufacturer submits a Dronedarone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Dronedarone CEP holder for the record. Additionally, the data presented in the Dronedarone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Dronedarone DMF.

A Dronedarone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dronedarone CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Dronedarone suppliers with CEP (COS) on PharmaCompass.

Dronedarone Manufacturers | Traders | Suppliers

Dronedarone Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Dronedarone

Get in contact with the supplier of your choice:

  1. Aurobindo Pharma Limited
  2. Aurore Life Sciences
  3. Enaltec Labs Private Limited
  4. MSN Laboratories
  5. Wisdom Pharmaceutical Co., Ltd.
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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